Cerebral PalsyNCT06673823
Effects of Mirror Therapy on Lower Extremity in CP Children
A study testing Mirror therapy and conventional therapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
A non-progressive condition that harms the developing brain both during and after birth is cerebral palsy (CP). It is a multifaceted syndrome marked by abnormalities in movement and posture, along with concomitant sensory-motor, cognitive, and behavioral impairments and seizures. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Mirror therapy and conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Oct 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-12 years.
- Motor tone of effected lower extremity is 1 to 2 according to modified Ashworth scale.
- Patient with enough cognition to understand and follow instructions
Who cannot join
- Patients with any other neurological illness affecting their lower extremities (e.g., MS, Parkinson's, peripheral neuropathy).
- Patients with prior fractures of the lower limb (ankle or foot).
- Patients with other forms of musculoskeletal diseases such as severe arthritis, ankle surgery, leg length difference.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Lahore, Punjab Province, 54000
Imran Amjad, 33224390125, Imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS, 03224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects Of Lower Extremity Mirror Therapy On Gait Parameters In Children With Hemiplegic Cerebral Palsy.
A non-progressive condition that harms the developing brain both during and after birth is cerebral palsy (CP). It is a multifaceted syndrome marked by abnormalities in movement and posture, along with concomitant sensory-motor, cognitive, and behavioral impairments and seizures. CP can be divided into three types based on neurological classification: spastic, athetoid, and ataxic, impairments in motor skills and posture are hallmarks of cerebral palsy. Various strategies have been employed in motor skill improvement interventions. One of them, mirror-mediated treatment, works by stimulating mirror neurons in a specific region of the brain cortex. Mirror-mediated therapy involves the patient observing movement of his or her own limb reflected in a mirror, which activates mirror neurons. The application of mirror treatment improved gait capacity by elevating physical perception and balance ability. The purpose of the study will be to evaluate the effects of mirror therapy in lower limb hemiplegic cerebral palsy.
Read the detailed description
A randomized controlled trial will be conducted to investigate the effects of mirror therapy in children with hemiplegic cerebral palsy. Data will be collected at the National Institute of Rehabilitation Medicine in Islamabad following ethical clearance. 26 patients will be enrolled in the study based on inclusion criteria. Patients will be randomly assigned into 2 equal groups for the study. Children in the control group will receive conventional therapy for 60 minutes, while Children in the experimental group will receive 30 minutes of mirror therapy and 30 minutes of conventional therapy, for 12 weeks, 3 days every week. The primary outcome will be measured by Selective Control Assessment of Lower Extremity scale (SCALE), while the secondary outcome will be measured by the Pediatric Balance Scale (PBS). All gait parameters (stride length, step length, step width, cadence and foot angle) will be measured before and after the application of intervention. Data will be analyzed using SPSS 27.0.
- Conditions
- Cerebral Palsy
- Being tested
- Mirror therapy, conventional therapy
- Keywords
- lower limb, mirror therapy, conventional therapy, spastic CP
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror therapyDevice
Mirror Therapy (MT) is a non-invasive treatment method aimed at addressing unilateral conditions impacting either the upper or lower limbs. This technique involves placing a mirror along the patient's sagittal plane, allowing the reflection of the unaffected limb to visually overlay the affected limb.
conventional therapyOther
conventional therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In the Experimental Group, Mirror Therapy will be applied by covering any birthmarks or scars on the less affected lower extremity (LE) if they obstruct the child's view. The therapy will take place in a distraction-free environment to help each child maintain focus and concentration. A mirror, at least 35 × 25 inches in size, will be placed between both LEs, with the more affected LE concealed behind a black curtain, allowing a clear reflection of the less affected LE. The child will be instructed to observe the mirror image of their more affected LE for one to two minutes. To begin, the therapist will visually demonstrate the technique. Receives: Device: Mirror therapy |
| Control group | Active comparator | In the Control Group, conventional therapy will include exercises such as stride standing to allow weight shifting between extremities, single leg standing, stooping and recovering from a standing position, standing on a balance board, and various balance training exercises. Additionally, the program will incorporate stretching exercises for the hip flexors, adductors, hamstrings, and calf muscles, along with gait training exercises conducted in an open environment. Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective Control Assessment of Lower Extremity scale (SCALE):
The Selective Control Assessment of the Lower Extremity (SCALE) is a clinical tool used to measure motor control in individuals with cerebral palsy. In this assessment, participants perform specific isolated movements at each joint, and each joint is scored to produce a total score per limb, with a maximum of 10 points per limb. SCALE demonstrates high interrater reliability, with intraclass correlation coefficients between 0.88 and 0.915. The assessment requires minimal training and takes approximately 10 to 15 minutes to complete.
Measured: 12 weeks
Pediatric Balance Scale (PBS);
The Pediatric Balance Scale is an adaptation of the Berg Balance Scale, designed to evaluate functional balance skills in children. It includes 14 items, each scored from 0 (indicating lowest function) to 4 (indicating highest function), with a maximum possible score of 56 points.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start29 Oct 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
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
- A randomized controlled trial will be conducted to investigate the effects of mirror therapy in children with hemiplegic cerebral palsy. Children in the control group will receive conventional therapy for 60 minutes, while Children in the experimental group will receive 30 minutes of mirror therapy and 30 minutes of conventional therapy, for 12 weeks, 3 days every week
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharmeen Arif, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673823
- Sponsor's protocol ID
- REC/RCR/AHA/24/sharmeen arif
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morris C. Definition and classification of cerebral palsy: a historical perspective. Dev Med Child Neurol Suppl. 2007 Feb;109:3-7. doi: 10.1111/j.1469-8749.2007.tb12609.x.
PubMed 17370476
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Lower Extremity Mirror Therapy On Gait Parameters In Children With Hemiplegic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT06673823
- Acronym / sponsor ID
- REC/RCR/AHA/24/sharmeen arif
- Conditions
- Cerebral Palsy
- Keywords
- lower limb, mirror therapy, conventional therapy, spastic CP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 5 Nov 2024 (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.
A non-progressive condition that harms the developing brain both during and after birth is cerebral palsy (CP). It is a multifaceted syndrome marked by abnormalities in movement and posture, along with concomitant sensory-motor, cognitive, and behavioral impairments and seizures. CP can be divided into three types based on neurological classification: spastic, athetoid, and ataxic, impairments in motor skills and posture are hallmarks of cerebral palsy. Various strategies have been employed in motor skill improvement interventions. One of them, mirror-mediated treatment, works by stimulating mirror neurons in a specific region of the brain cortex. Mirror-mediated therapy involves the patient observing movement of his or her own limb reflected in a mirror, which activates mirror neurons. The application of mirror treatment improved gait capacity by elevating physical perception and balance ability. The purpose of the study will be to evaluate the effects of mirror therapy in lower limb hemiplegic cerebral palsy.
Detailed description
A randomized controlled trial will be conducted to investigate the effects of mirror therapy in children with hemiplegic cerebral palsy. Data will be collected at the National Institute of Rehabilitation Medicine in Islamabad following ethical clearance. 26 patients will be enrolled in the study based on inclusion criteria. Patients will be randomly assigned into 2 equal groups for the study. Children in the control group will receive conventional therapy for 60 minutes, while Children in the experimental group will receive 30 minutes of mirror therapy and 30 minutes of conventional therapy, for 12 weeks, 3 days every week. The primary outcome will be measured by Selective Control Assessment of Lower Extremity scale (SCALE), while the secondary outcome will be measured by the Pediatric Balance Scale (PBS). All gait parameters (stride length, step length, step width, cadence and foot angle) will be measured before and after the application of intervention. Data will be analyzed using SPSS 27.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized controlled trial will be conducted to investigate the effects of mirror therapy in children with hemiplegic cerebral palsy. Children in the control group will receive conventional therapy for 60 minutes, while Children in the experimental group will receive 30 minutes of mirror therapy and 30 minutes of conventional therapy, for 12 weeks, 3 days every week
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Mirror therapyIn the Experimental Group, Mirror Therapy will be applied by covering any birthmarks or scars on the less affected lower extremity (LE) if they obstruct the child's view. The therapy will take place in a distraction-free environment to help each child maintain focus and concentration. A mirror, at least 35 × 25 inches in size, will be placed between both LEs, with the more affected LE concealed behind a black curtain, allowing a clear reflection of the less affected LE. The child will be instructed to observe the mirror image of their more affected LE for one to two minutes. To begin, the therapist will visually demonstrate the technique. |
| Control group | Active comparator | Other: conventional therapyIn the Control Group, conventional therapy will include exercises such as stride standing to allow weight shifting between extremities, single leg standing, stooping and recovering from a standing position, standing on a balance board, and various balance training exercises. Additionally, the program will incorporate stretching exercises for the hip flexors, adductors, hamstrings, and calf muscles, along with gait training exercises conducted in an open environment. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6-12 years.
- Motor tone of effected lower extremity is 1 to 2 according to modified Ashworth scale.
- Patient with enough cognition to understand and follow instructions
Key exclusion criteria (3 listed)
- Patients with any other neurological illness affecting their lower extremities (e.g., MS, Parkinson's, peripheral neuropathy).
- Patients with prior fractures of the lower limb (ankle or foot).
- Patients with other forms of musculoskeletal diseases such as severe arthritis, ankle surgery, leg length difference.
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 |
|---|---|---|
| Mirror therapyMirror Therapy (MT) is a non-invasive treatment method aimed at addressing unilateral conditions impacting either the upper or lower limbs. This technique involves placing a mirror along the patient's sagittal plane, allowing the reflection of the unaffected limb to visually overlay the affected limb. | Device | Experimental group |
| conventional therapyconventional therapy | Other | Control group |
Primary outcome
Selective Control Assessment of Lower Extremity scale (SCALE):
Time frame: 12 weeks
The Selective Control Assessment of the Lower Extremity (SCALE) is a clinical tool used to measure motor control in individuals with cerebral palsy. In this assessment, participants perform specific isolated movements at each joint, and each joint is scored to produce a total score per limb, with a maximum of 10 points per limb. SCALE demonstrates high interrater reliability, with intraclass correlation coefficients between 0.88 and 0.915. The assessment requires minimal training and takes approximately 10 to 15 minutes to complete.
Pediatric Balance Scale (PBS);
Time frame: 12 weeks
The Pediatric Balance Scale is an adaptation of the Berg Balance Scale, designed to evaluate functional balance skills in children. It includes 14 items, each scored from 0 (indicating lowest function) to 4 (indicating highest function), with a maximum possible score of 56 points.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 17370476Morris C. Definition and classification of cerebral palsy: a historical perspective. Dev Med Child Neurol Suppl. 2007 Feb;109:3-7. doi: 10.1111/j.1469-8749.2007.tb12609.x.
- 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.
Sharmeen Arif, MS* 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 Mirror therapy and conventional therapy 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 3 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: looking for participants now, as of the sponsor's last update on 5 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (: 9233224390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective Control Assessment of Lower Extremity scale (SCALE): (time frame: 12 weeks). The study lists 2 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 NCT06673823, 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 5 Nov 2024.