Cerebral PalsyNCT05751135
Impact of Focal Muscle Vibration on Bio-psychosocial Outcomes in Cerebral Palsy
A study testing Focal muscle vibration, Stretching and Strengthening in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to determine the effects of focal muscle vibration on bio-psychosocial outcomes in subjects with cerebral palsy. Mixed methods will be used and the study will be conducted in 2 phases; 1st phase is determining the effects of intervention, whereas second step is prediction of outcomes. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Focal muscle vibration, Stretching and Strengthening
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Mar 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed spastic diplegic cerebral palsy cases with following characteristics;
- Gross motor function classification scale levels II-IV
- Receiving standard physical therapy care
Who cannot join
- Severe cognitive, visual and hearing impairments.
- History of metabolic diseases.
- History of recent fractures.
- Children with severe musculo-skeletal anomalies
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Al-Farabi Special Education Center For (P.H.C)
Islamabad, 44000
About this study
This study aims to determine the effects of focal muscle vibration on bio-psychosocial outcomes in subjects with cerebral palsy. Mixed methods will be used and the study will be conducted in 2 phases; 1st phase is determining the effects of intervention, whereas second step is prediction of outcomes. A qualitative gait analysis will also be done.
Read the detailed description
The literature suggests the positive effects of focal muscle vibration on various motor components of cerebral palsy. Although there is a gap regarding it's effects with perspective of bio-psychosocial model, which will be the main focus of this study. The study will look for the effects of focal muscle vibration on biological, psychological and social aspects of subjects with cerebral palsy (CP). The intervention in form of focal muscle vibration and standard physical therapy will be provided for 12 weeks and the subjects will then be followed for 4 weeks to look for retention effects, and till 24 weeks for prediction of outcomes.
- Conditions
- Cerebral Palsy
- Being tested
- Focal muscle vibration, Stretching, Strengthening, Positioning
- Keywords
- Cerebral palsy, Focal muscle vibration, Biopsychosocial, Functional near-infrared spectroscopy, Electroencephalography, Emotional reactivity
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal muscle vibrationDevice
Focal muscle vibration will be provided by a longitudinal muscle vibrator on muscles of lower limb; hamstrings, quadriceps, illiopsoas, calf, gluteus maximus and medius. Each muscle will be targeted 3 times with 30 seconds time period and keeping 10 second interval.
StretchingProcedure or surgery
Stretching of shortened lower extremity muscle
StrengtheningProcedure or surgery
Strengthening exercises for weak lower extremity muscles
PositioningProcedure or surgery
Positioning of participant to maintain a good body posture
| Study group | Role | What they receive |
|---|---|---|
| Focal muscle vibration group 1 | Experimental | Focal muscle vibration with frequency of 80 Hz will be provided 3 days along with stretching, strengthening and positioning for 8 weeks Receives: Device: Focal muscle vibration; Procedure: Stretching; Procedure: Strengthening; Procedure: Positioning |
| Focal muscle vibration group 2 | Experimental | Focal muscle vibration with frequency of 100 Hz will be provided 3 days a week along with stretching, strengthening and positioning for 8 weeks. Receives: Device: Focal muscle vibration; Procedure: Stretching; Procedure: Strengthening; Procedure: Positioning |
| Control group | Active comparator | Stretching, strengthening and positioning in 3 sessions a week for 8 weeks Receives: Procedure: Stretching; Procedure: Strengthening; Procedure: Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional near-infrared spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.
Measured: Baseline
Functional near-infrared spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.
Measured: After 4 weeks
Functional near-infrared spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.
Measured: After 8 weeks
Electroencephalogram (EEG)
The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.
Measured: Baseline
Electroencephalogram (EEG)
The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.
Measured: After 4 weeks
Electroencephalogram (EEG)
The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.
Measured: After 8 weeks
Gross Motor Function Measure
Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity
Measured: Baseline
Gross Motor Function Measure
Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity
Measured: After 4 weeks
Gross Motor Function Measure
Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity
Measured: After 8 weeks
Gross Motor Function Measure
Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity
Measured: After 12 weeks
Modified Ashworth scale
It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension
Measured: Baseline
Modified Ashworth scale
It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension
Measured: After 4 weeks
Modified Ashworth scale
It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension
Measured: After 8 weeks
Modified Ashworth scale
It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension
Measured: After 12 weeks
Child Behavior Checklist (CBCL)
The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.
Measured: Baseline
Child Behavior Checklist (CBCL)
The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.
Measured: After 4 weeks
Child Behavior Checklist (CBCL)
The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.
Measured: After 8 weeks
Child Behavior Checklist (CBCL)
The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.
Measured: After 12 weeks
Social support questionnaire
A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support
Measured: Baseline
Social support questionnaire
A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support
Measured: After 4 weeks
Social support questionnaire
A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support
Measured: After 8 weeks
Social support questionnaire
A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support
Measured: After 12 weeks
Self perception profile
Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.
Measured: Baseline
Self perception profile
Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.
Measured: After 4 weeks
Self perception profile
Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.
Measured: After 8 weeks
Self perception profile
Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.
Measured: After 12 weeks
Perth Emotional Reactivity Scale (PERS-S)
The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.
Measured: Baseline
Perth Emotional Reactivity Scale (PERS-S)
The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.
Measured: After 4 weeks
Perth Emotional Reactivity Scale (PERS-S)
The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.
Measured: After 8 weeks
Perth Emotional Reactivity Scale (PERS-S)
The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.
Measured: After 12 weeks
Modified Caregiver Strain Index (MCSI)
The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.
Measured: Baseline
Modified Caregiver Strain Index (MCSI)
The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.
Measured: After 4 weeks
Modified Caregiver Strain Index (MCSI)
The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.
Measured: After 8 weeks
Modified Caregiver Strain Index (MCSI)
The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.
Measured: After 12 weeks
Electromyography (EMG)
EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.
Measured: Baseline
Electromyography (EMG)
EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.
Measured: After 4 weeks
Electromyography (EMG)
EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.
Measured: After 8 weeks
Trunk control measurement scale (TCMS)
Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.
Measured: Baseline
Trunk control measurement scale (TCMS)
Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.
Measured: After 4 weeks
Trunk control measurement scale (TCMS)
Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.
Measured: After 8 weeks
Trunk control measurement scale (TCMS)
Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.
Measured: After 12 weeks
Pediatric Balance Scale (PBS)
Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.
Measured: Baseline
Pediatric Balance Scale (PBS)
Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.
Measured: After 4 weeks
Pediatric Balance Scale (PBS)
Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.
Measured: After 8 weeks
Pediatric Balance Scale (PBS)
Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance, while score closer to zero indicate impaired balance.
Measured: After 12 weeks
Dynamometer
The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects
Measured: Bassline
Dynamometer
The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects
Measured: After 4 weeks
Dynamometer
The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects
Measured: After 8 weeks
Dynamometer
The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects
Measured: After 12 weeks
Cerebral Palsy Quality of Life (CPQOL)
Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain
Measured: Baseline
Cerebral Palsy Quality of Life (CPQOL)
Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain
Measured: After 4 weeks
Cerebral Palsy Quality of Life (CPQOL)
Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain
Measured: After 8 weeks
Cerebral Palsy Quality of Life (CPQOL)
Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain
Measured: After 12 weeks
Edinburgh Visual Gait Assessment Score
Edinburgh Visual Gait Assessment (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.
Measured: Baseline
Edinburgh Visual Gait Assessment Score
Edinburgh Visual Gait Assessment (EVGA ) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.
Measured: After 4 weeks
Edinburgh Visual Gait Assessment Score
Edinburgh Visual Gait Assessment Score (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.
Measured: After 8 weeks
Edinburgh Visual Gait Assessment Score
Edinburgh Visual Gait Assessment Score (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.
Measured: After 12 weeks
Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children
Measured: Baseline
Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children
Measured: After 4 weeks
Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children
Measured: After 8 weeks
Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children
Measured: After 12 weeks
Immune Response Questionnaire (IRQ)
The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status
Measured: Baseline
Immune Response Questionnaire (IRQ)
The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status
Measured: After 4 weeks
Immune Response Questionnaire (IRQ)
The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status
Measured: After 8 weeks
Immune Response Questionnaire (IRQ)
The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status
Measured: After 12 weeks
Reaction Time
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.
Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.
More accurate reaction in less time inclines toward good reaction time
Measured: Baseline
Reaction Time
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.
Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.
More accurate reaction in less time inclines toward good reaction time
Measured: After 4 weeks
Reaction Time
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.
Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.
More accurate reaction in less time inclines toward good reaction time
Measured: After 8 weeks
Reaction Time
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity.
Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission.
More accurate reaction in less time inclines toward good reaction time
Measured: After 12 weeks
Heart rate variability (HRV)
Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention.
Measured: Baseline
Heart rate variability (HRV)
Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention
Measured: After 4 weeks
Heart rate variability (HRV)
Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention
Measured: After 8 weeks
Heart rate variability (HRV)
Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention
Measured: After 12 weeks
Manual Muscle Testing (MMT)
Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.
Measured: Baseline
Manual Muscle Testing (MMT)
Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.
Measured: After 4 weeks
Manual Muscle Testing (MMT)
Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.
Measured: After 8 weeks
Manual Muscle Testing (MMT)
Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.
Measured: After 12 weeks
Semi structured interview
A semi-structured interview will be conducted with parents/ caregivers of CP subjects focusing on the feedback about treatment protocols and social, psychological and physical status and needs, and any observed change in needs or status
Measured: After 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start3 Mar 2023
- Primary completion30 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 parallel group mixed methods
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International UniversityKiran Khushnood, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751135
- Sponsor's protocol ID
- REC-01289 KiranKhushnood
- Status last verified
- Jan 2024
- First submitted
- 20 Feb 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ashfaque M, Khushnood K, Naik GR, Niazi IK, Amjad I, Pujari AN. Eight weeks of focal muscle vibration shows improvements in muscle co-ordination and co-contraction in cerebral palsy children: a randomized control trial. J Neuroeng Rehabil. 2026 Jul 30;23(1):250. doi: 10.1186/s12984-026-02066-8.
PubMed 42642763
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Focal Muscle Vibration on Bio-psychosocial Outcomes in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05751135
- Acronym / sponsor ID
- REC-01289 KiranKhushnood
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Focal muscle vibration, Biopsychosocial, Functional near-infrared spectroscopy, Electroencephalography, Emotional reactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effects of focal muscle vibration on bio-psychosocial outcomes in subjects with cerebral palsy. Mixed methods will be used and the study will be conducted in 2 phases; 1st phase is determining the effects of intervention, whereas second step is prediction of outcomes. A qualitative gait analysis will also be done.
Detailed description
The literature suggests the positive effects of focal muscle vibration on various motor components of cerebral palsy. Although there is a gap regarding it's effects with perspective of bio-psychosocial model, which will be the main focus of this study. The study will look for the effects of focal muscle vibration on biological, psychological and social aspects of subjects with cerebral palsy (CP). The intervention in form of focal muscle vibration and standard physical therapy will be provided for 12 weeks and the subjects will then be followed for 4 weeks to look for retention effects, and till 24 weeks for prediction of outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 parallel group mixed methods
| Arm | Type | Receives |
|---|---|---|
| Focal muscle vibration group 1 | Experimental | Device: Focal muscle vibration, Procedure: Stretching, Procedure: Strengthening, Procedure: PositioningFocal muscle vibration with frequency of 80 Hz will be provided 3 days along with stretching, strengthening and positioning for 8 weeks |
| Focal muscle vibration group 2 | Experimental | Device: Focal muscle vibration, Procedure: Stretching, Procedure: Strengthening, Procedure: PositioningFocal muscle vibration with frequency of 100 Hz will be provided 3 days a week along with stretching, strengthening and positioning for 8 weeks. |
| Control group | Active comparator | Procedure: Stretching, Procedure: Strengthening, Procedure: PositioningStretching, strengthening and positioning in 3 sessions a week for 8 weeks |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed spastic diplegic cerebral palsy cases with following characteristics;
- Gross motor function classification scale levels II-IV
- Receiving standard physical therapy care
Key exclusion criteria (4 listed)
- Severe cognitive, visual and hearing impairments.
- History of metabolic diseases.
- History of recent fractures.
- Children with severe musculo-skeletal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focal muscle vibrationFocal muscle vibration will be provided by a longitudinal muscle vibrator on muscles of lower limb; hamstrings, quadriceps, illiopsoas, calf, gluteus maximus and medius. Each muscle will be targeted 3 times with 30 seconds time period and keeping 10 second interval. | Device | Focal muscle vibration group 1, Focal muscle vibration group 2 |
| StretchingStretching of shortened lower extremity muscle | Procedure or surgery | Control group, Focal muscle vibration group 1, Focal muscle vibration group 2 |
| StrengtheningStrengthening exercises for weak lower extremity muscles | Procedure or surgery | Control group, Focal muscle vibration group 1, Focal muscle vibration group 2 |
| PositioningPositioning of participant to maintain a good body posture | Procedure or surgery | Control group, Focal muscle vibration group 1, Focal muscle vibration group 2 |
Primary outcome
Functional near-infrared spectroscopy (fNIRS)
Time frame: Baseline
Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.
Functional near-infrared spectroscopy (fNIRS)
Time frame: After 4 weeks
Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.
Functional near-infrared spectroscopy (fNIRS)
Time frame: After 8 weeks
Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks.
Electroencephalogram (EEG)
Time frame: Baseline
The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.
Electroencephalogram (EEG)
Time frame: After 4 weeks
The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.
Electroencephalogram (EEG)
Time frame: After 8 weeks
The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention.
Gross Motor Function Measure
Time frame: Baseline
Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity
Gross Motor Function Measure
Time frame: After 4 weeks
Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity
Gross Motor Function Measure
Time frame: After 8 weeks
Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity
Gross Motor Function Measure
Time frame: After 12 weeks
Gross motor function measure is a standard instrument which measures the change in motor function with time in CP subjects. It assess the amount of motor task a child can perform. an 88 point tool with scoring of 0-3 for each item, with 0 = doesn't initate activity to 3= complete the activity
Modified Ashworth scale
Time frame: Baseline
It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension
Modified Ashworth scale
Time frame: After 4 weeks
It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension
Modified Ashworth scale
Time frame: After 8 weeks
It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension
Modified Ashworth scale
Time frame: After 12 weeks
It is standard tool for measuring the spasticity with scoring 0-5, 0=no increase in muscle tone to 5=rigid in flexion and extension
Child Behavior Checklist (CBCL)
Time frame: Baseline
The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.
Child Behavior Checklist (CBCL)
Time frame: After 4 weeks
The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.
Child Behavior Checklist (CBCL)
Time frame: After 8 weeks
The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.
Child Behavior Checklist (CBCL)
Time frame: After 12 weeks
The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioral problems in children and adolescents. There are 2 checklists; 1 for ages 1.5 to 5 years and other for 6 to 18 years of age.
Social support questionnaire
Time frame: Baseline
A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support
Social support questionnaire
Time frame: After 4 weeks
A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support
Social support questionnaire
Time frame: After 8 weeks
A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support
Social support questionnaire
Time frame: After 12 weeks
A 6 item questionnaire designed to measure perceptions of social support and satisfaction with that social support
Self perception profile
Time frame: Baseline
Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.
Self perception profile
Time frame: After 4 weeks
Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.
Self perception profile
Time frame: After 8 weeks
Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.
Self perception profile
Time frame: After 12 weeks
Targeting the self-perception this tool is used to determine global psychosocial function and encompasses major domains; scholastic, social, athletic competence, physical appearance, behavioral conduct and global self-worth. There are 6 domains with 36 items in total with in each item is scored on a four-point scale from 1 to 4.
Perth Emotional Reactivity Scale (PERS-S)
Time frame: Baseline
The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.
Perth Emotional Reactivity Scale (PERS-S)
Time frame: After 4 weeks
The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.
Perth Emotional Reactivity Scale (PERS-S)
Time frame: After 8 weeks
The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.
Perth Emotional Reactivity Scale (PERS-S)
Time frame: After 12 weeks
The Perth Emotional Reactivity Scale (PERS-S) is 18 item self-report measure of trait levels of emotional reactivity, derived from original version of 30 item.
Modified Caregiver Strain Index (MCSI)
Time frame: Baseline
The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.
Modified Caregiver Strain Index (MCSI)
Time frame: After 4 weeks
The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.
Modified Caregiver Strain Index (MCSI)
Time frame: After 8 weeks
The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.
Modified Caregiver Strain Index (MCSI)
Time frame: After 12 weeks
The Modified Caregiver Strain Index (MCSI) is used to screen for caregiver strain with long-term family caregivers. It is short and quick with 13 questions, which measures strain related to care provision.
Electromyography (EMG)
Time frame: Baseline
EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.
Electromyography (EMG)
Time frame: After 4 weeks
EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.
Electromyography (EMG)
Time frame: After 8 weeks
EMG will identify any changes in co-contraction between the muscles; quadriceps and hamstrings.
Trunk control measurement scale (TCMS)
Time frame: Baseline
Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.
Trunk control measurement scale (TCMS)
Time frame: After 4 weeks
Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.
Trunk control measurement scale (TCMS)
Time frame: After 8 weeks
Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.
Trunk control measurement scale (TCMS)
Time frame: After 12 weeks
Trunk control measurement scale will determine the level of trunk control in a child with CP. It comprises of static and dynamic sitting balance along with reaching activities which determine the equilibrium. The maximum score is 58, the higher the scores indicate better trunk control.
Pediatric Balance Scale (PBS)
Time frame: Baseline
Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.
Pediatric Balance Scale (PBS)
Time frame: After 4 weeks
Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.
Pediatric Balance Scale (PBS)
Time frame: After 8 weeks
Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance while score closer to zero indicate impaired balance.
Pediatric Balance Scale (PBS)
Time frame: After 12 weeks
Pediatric Balance Scale will determine the level of balance and postural control in a child with CP. The maximum score is 56 and higher scores indicate better level of balance, while score closer to zero indicate impaired balance.
Dynamometer
Time frame: Bassline
The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects
Dynamometer
Time frame: After 4 weeks
The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects
Dynamometer
Time frame: After 8 weeks
The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects
Dynamometer
Time frame: After 12 weeks
The dynamometer will be used to determine the strength in lower limb muscles; quadriceps, hamstrings, adductors and abductors of the CP subjects
Cerebral Palsy Quality of Life (CPQOL)
Time frame: Baseline
Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain
Cerebral Palsy Quality of Life (CPQOL)
Time frame: After 4 weeks
Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain
Cerebral Palsy Quality of Life (CPQOL)
Time frame: After 8 weeks
Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain
Cerebral Palsy Quality of Life (CPQOL)
Time frame: After 12 weeks
Cerebral Palsy Quality of Life is tool to access the quality of life of children with CP it incorporates parental impact and family functioning along with concepts of illness, functional status, mental health, and comfort. Items are transformed to range of 0-100, the algebraic mean of item values is computer for each domain
Edinburgh Visual Gait Assessment Score
Time frame: Baseline
Edinburgh Visual Gait Assessment (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.
Edinburgh Visual Gait Assessment Score
Time frame: After 4 weeks
Edinburgh Visual Gait Assessment (EVGA ) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.
Edinburgh Visual Gait Assessment Score
Time frame: After 8 weeks
Edinburgh Visual Gait Assessment Score (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.
Edinburgh Visual Gait Assessment Score
Time frame: After 12 weeks
Edinburgh Visual Gait Assessment Score (EVGA) is an assessment tool which qualitatively asses various parameters of gait via video recordings. It uses lateral and anterior views of gait to identify the quality of gait patterns and movements.
Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
Time frame: Baseline
A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children
Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
Time frame: After 4 weeks
A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children
Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
Time frame: After 8 weeks
A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children
Child friendly Depression Anxiety Stress Scale 21 (DASS-21)
Time frame: After 12 weeks
A 21 item scale derive from DASS 42 to access the depression, anxiety and stress among children
Immune Response Questionnaire (IRQ)
Time frame: Baseline
The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status
Immune Response Questionnaire (IRQ)
Time frame: After 4 weeks
The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status
Immune Response Questionnaire (IRQ)
Time frame: After 8 weeks
The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status
Immune Response Questionnaire (IRQ)
Time frame: After 12 weeks
The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. Assessment of participants will be repeated after 6 weeks of intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the "raw" IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status
Reaction Time
Time frame: Baseline
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time
Reaction Time
Time frame: After 4 weeks
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time
Reaction Time
Time frame: After 8 weeks
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time
Reaction Time
Time frame: After 12 weeks
Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time
Heart rate variability (HRV)
Time frame: Baseline
Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention.
Heart rate variability (HRV)
Time frame: After 4 weeks
Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention
Heart rate variability (HRV)
Time frame: After 8 weeks
Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention
Heart rate variability (HRV)
Time frame: After 12 weeks
Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention
Manual Muscle Testing (MMT)
Time frame: Baseline
Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.
Manual Muscle Testing (MMT)
Time frame: After 4 weeks
Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.
Manual Muscle Testing (MMT)
Time frame: After 8 weeks
Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.
Manual Muscle Testing (MMT)
Time frame: After 12 weeks
Manual muscle testing will be used to determine the strength of lower limb muscles. It has scores from 0 to 5, with 5 being the movement against maximum resistance and 0 being no contraction.
Semi structured interview
Time frame: After 8 weeks
A semi-structured interview will be conducted with parents/ caregivers of CP subjects focusing on the feedback about treatment protocols and social, psychological and physical status and needs, and any observed change in needs or status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Derived from this study: PubMed 42642763Ashfaque M, Khushnood K, Naik GR, Niazi IK, Amjad I, Pujari AN. Eight weeks of focal muscle vibration shows improvements in muscle co-ordination and co-contraction in cerebral palsy children: a randomized control trial. J Neuroeng Rehabil. 2026 Jul 30;23(1):250. doi: 10.1186/s12984-026-02066-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Amjad, PhD principal investigator
Riphah International University
Kiran Khushnood, MSNMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal muscle vibration, Stretching and Strengthening in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional near-infrared spectroscopy (fNIRS) (time frame: Baseline). The study lists 78 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05751135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.