Spastic Diplegia Cerebral PalsyNCT06966609
Additional Effects of Cuevas Medek Exercises Along With Conventional Physical Therapy on Gross Motor Proficiency and Quality of Life, in Children With Spastic Diplegic Cerebral Palsy
A study testing Experimental Group in people with Spastic Diplegia Cerebral Palsy and Quality of Lifte, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Cerebral palsy (CP) is a prevalent pediatric neurological disorder hindering movement and posture development due to non-progressive disruptions in brain development. Motor disorders along with dysfunctions in sensations, perception, cognition, communication, behavior and secondary musculoskeletal problems are also… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Spastic Diplegia Cerebral Palsy, Quality of Lifte, Motor Function
- What is being tested?
- Experimental Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2024to 20 Dec 2024
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed spastic diplegic cerebral palsy children
- age group 6-12 years old
- both male and female
- GMFCS II \& III
- parents of spastic diplegic CP child
Who cannot join
- diagnosed cognitive impairment
- diagnosed hearing impairment and visual impairment
- children with planned surgical procedures during study period
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Thrapy
Islamabad, 44000
About this study
Cerebral palsy (CP) is a prevalent pediatric neurological disorder hindering movement and posture development due to non-progressive disruptions in brain development. Motor disorders along with dysfunctions in sensations, perception, cognition, communication, behavior and secondary musculoskeletal problems are also present in children with CP.
Cuevas Medek Exercises (CME) is an innovative, intensive and dynamic therapy approach for management of movement disorders. It evoke automatic postural responses in children with motor delay problems by application of distal support, triggering stronger gravity induced reactions to enhanced motor output by compelling both mind and body responses.
It incorporates antigravity posture, ROM, weight-bearing, and stretching into functional exercises; for improved agility, flexibility, balance and coordination.
Read the detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the additional effect of Cuevas Medek Exercises with conventional exercises on gross motor proficiency in children with spastic diplegic cerebral palsy.
- To determine the additional effect of Cuevas Medek Exercises with conventional exercises on quality of life of caregiver and children with spastic diplegic cerebral palsy.
HYPOTHESIS:
Alternate Hypothesis:
- There is a statistically significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on gross motor proficiency in children with spastic diplegic cerebral palsy. (p\<0.05)
- There is a statistically significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on quality of life in children with spastic diplegic cerebral palsy. (p\<0.05)
Null Hypothesis:
- There is a statistically no significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on gross motor proficiency in children with spastic diplegic cerebral palsy. (p\>0.05)
- There is a statistically no significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on quality of life in children with spastic diplegic cerebral palsy. (p\>0.05)
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Fauji Foundation Hospital Study duration 1 year following synopsis approval.(Feb 2024- Jan 2025)
Selection Criteria:
Inclusion Criteria
- diagnosed spastic diplegic cerebral palsy children
- age group 6-12 years old
- both male and female
- GMFCS II \& III
- parents of spastic diplegic CP child
Exclusion Criteria
- diagnosed cognitive impairment
- diagnosed hearing impairment and visual impairment
- children with planned surgical procedures during study period
Sampling technique: convenicence sampling
Outcome Measures:
- Gross motor function measure
- CP QOL - CHILD
Data analysis techniques:
Data will be analyzed using SPSS version 20.0.0.
Significance of the study:
- Till date no study has yet evaluated the effect of Cuevas Medek Exrcises on gross motor proficiency and quality of life in children with spastic diplegic cerebral palsy. Therefore, advancement in the scientific knowledge can be achieved.
- Caregivers of cerebral palsy suffer from a substantial psychosocial burden. Therefore, to determine whether CME Therapy effects functional dependency and quality of life of both patient and caregivers.
- This study will contribute to future research directions and encouraging further exploration of CME Therapy as a promising intervention for spastic diplegic cerebral palsy.
- Being tested
- Control Group, Experimental Group
- Keywords
- Spastic Diplegic Cerebral Palsy, Gross motor proficiency, quality of life
- Medical subject headings
- Cerebral palsy, spastic, diplegic, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupProcedure or surgery
Conventional Physical Therapy ( 12 weeks intervention) 24 randomly allocated participants will get the conventional physical therapy that includes the stretching exercises (PNF technique) for 6 weeks; targeting all the affected lower limb muscles, strengthening exercises of all the weak lower limb muscles for 12 weeks along with gait training on parallel bars. Duration of session is 45 min.
Experimental GroupProcedure or surgery
Conventional Physical Therapy and Cuevas Medek Exercises ( 12 weeks intervention) 24 randomly allocated participants will get the conventional physical therapy that includes the stretching exercises (PNF technique) for 6 weeks; targeting all the affected lower limb muscles, strengthening exercises of all the weak lower limb muscles for 12 weeks along with gait training on parallel bars.Along with conventional physical therapy, experimental group participants will get Cuevas Medek Exercises that includes antigravity exercises, specefic types of stretchings and balancing exercises. Types of exercises that will be performed on the patient out of 100 exercises,will depend on the patient's need that is affecting his or her gross motor proficiency.Total duration of session is 90 min.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group A | Experimental | It includes participants receiving cuevas medek exercise combined with conventional physical therapy for 12 weeks treatment.
1. Stretching Exercises (PNF stretching)
* 0-6 weeks; 3 sets (5 repetition of 20sec) 4 times a week
* 6-12 weeks; 3 sets(10 repetition of 60sec) 4 times a week
* Muscles included:
Flexors (hip, knee, ankle), extensors (hip, knee, ankle), abductor(hip) and adductors(hip)
2. Strengthening Exercises (Isometric muscle strengthening )
* 3 sets ( 10 repetition)
* Rest interval: 1min
* Frequency: 3 times a week
* Muscles included:
Flexors(hip, knee, ankle), extensors(hip, knee, ankle), abductor(hip) and adductors(hip) 3. Gait training Parallel bar walking 4. Cuevas Medek Exercise(99 exercises)
* Frequency: 3 times a week
* Duration: 45mins
* Repetition: 3-8 times
* Exercises divided into following, will be administered according to patient need/goal;
1. Head control
2. Trunk control
3. Trunk and hip control
4. Coordination
5. Balance reaction
6. Stability Receives: Procedure: Experimental Group |
| Interventional Group B | Active comparator | It includes participants receiving conventional physical therapy for 12 weeks treatment.
1. Stretching Exercises (PNF stretching)
* 0-6 weeks; 3 sets (5 repetition of 20sec) 4 times a week
* 6-12 weeks; 3 sets(10 repetition of 60sec) 4 times a week
* Muscles included:
Flexors (hip, knee, ankle), extensors (hip, knee, ankle), abductor(hip) and adductors(hip)
2. Strengthening Exercises (Isometric muscle strengthening )
* 3 sets ( 10 repetition)
* Rest interval: 1min
* Frequency: 3 times a week
* Muscles included:
Flexors(hip, knee, ankle), extensors(hip, knee, ankle), abductor(hip) and adductors(hip)
3. Gait training Parallel bar walking Treatment time: 45mins Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function
Gross Motor Function Measure-88 score, will be used to assess gross motor function in children with cerebral palsy. It is a four point scale, consists of 88 items divided into five dimensions of gross motor function: a. lying and rolling, b. crawling and kneeling, c. sitting, d. standing, e. walking, running and jumping. It takes about 45 to 60 minutes. Equipments required for this measure tool are; mat, bench, toy and access to stairs.
Item scores are summed to calculate raw and percent scores for each of the five dimensions. Then, Average the percent scores for each dimension to get the total score. Total score (in percent), will be compared on each assessment to find out the improvement in the individual through that specefic intervention.
Measured: 12 weeks
Quality of Life
CP QOL Child Primary Caregiver It is a validated questionnaire that assesses the subjective well- being and happiness of children with CP. It consist of 66 questions and should be answered by caregivers of CP child, who report their perception of their child's quality of life of areas: well being and social acceptance, functionality, participation and physical health, emotional well being and self esteem, access to services, pain and disability impact and family health. The questionnaire is scored by summing the items to get a total score, with higher scores representing better quality of life.
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 posted13 May 2025
- Study start10 Jun 2024
- Primary completion1 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Diplegia Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966609
- Sponsor's protocol ID
- FUI/CTR/2024/36
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Cuevas Medek Exercises Along With Conventional Physical Therapy on Gross Motor Proficiency and Quality of Life, in Children With Spastic Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06966609
- Acronym / sponsor ID
- FUI/CTR/2024/36
- Keywords
- Spastic Diplegic Cerebral Palsy, Gross motor proficiency, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 13 May 2025 (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.
Cerebral palsy (CP) is a prevalent pediatric neurological disorder hindering movement and posture development due to non-progressive disruptions in brain development. Motor disorders along with dysfunctions in sensations, perception, cognition, communication, behavior and secondary musculoskeletal problems are also present in children with CP.
Cuevas Medek Exercises (CME) is an innovative, intensive and dynamic therapy approach for management of movement disorders. It evoke automatic postural responses in children with motor delay problems by application of distal support, triggering stronger gravity induced reactions to enhanced motor output by compelling both mind and body responses.
It incorporates antigravity posture, ROM, weight-bearing, and stretching into functional exercises; for improved agility, flexibility, balance and coordination.
Detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the additional effect of Cuevas Medek Exercises with conventional exercises on gross motor proficiency in children with spastic diplegic cerebral palsy.
- To determine the additional effect of Cuevas Medek Exercises with conventional exercises on quality of life of caregiver and children with spastic diplegic cerebral palsy.
HYPOTHESIS:
Alternate Hypothesis:
- There is a statistically significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on gross motor proficiency in children with spastic diplegic cerebral palsy. (p\<0.05)
- There is a statistically significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on quality of life in children with spastic diplegic cerebral palsy. (p\<0.05)
Null Hypothesis:
- There is a statistically no significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on gross motor proficiency in children with spastic diplegic cerebral palsy. (p\>0.05)
- There is a statistically no significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on quality of life in children with spastic diplegic cerebral palsy. (p\>0.05)
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Fauji Foundation Hospital Study duration 1 year following synopsis approval.(Feb 2024- Jan 2025)
Selection Criteria:
Inclusion Criteria
- diagnosed spastic diplegic cerebral palsy children
- age group 6-12 years old
- both male and female
- GMFCS II \& III
- parents of spastic diplegic CP child
Exclusion Criteria
- diagnosed cognitive impairment
- diagnosed hearing impairment and visual impairment
- children with planned surgical procedures during study period
Sampling technique: convenicence sampling
Outcome Measures:
- Gross motor function measure
- CP QOL - CHILD
Data analysis techniques:
Data will be analyzed using SPSS version 20.0.0.
Significance of the study:
- Till date no study has yet evaluated the effect of Cuevas Medek Exrcises on gross motor proficiency and quality of life in children with spastic diplegic cerebral palsy. Therefore, advancement in the scientific knowledge can be achieved.
- Caregivers of cerebral palsy suffer from a substantial psychosocial burden. Therefore, to determine whether CME Therapy effects functional dependency and quality of life of both patient and caregivers.
- This study will contribute to future research directions and encouraging further exploration of CME Therapy as a promising intervention for spastic diplegic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group A | Experimental | Procedure: Experimental GroupIt includes participants receiving cuevas medek exercise combined with conventional physical therapy for 12 weeks treatment. 1. Stretching Exercises (PNF stretching) * 0-6 weeks; 3 sets (5 repetition of 20sec) 4 times a week * 6-12 weeks; 3 sets(10 repetition of 60sec) 4 times a week * Muscles included: Flexors (hip, knee, ankle), extensors (hip, knee, ankle), abductor(hip) and adductors(hip) 2. Strengthening Exercises (Isometric muscle strengthening ) * 3 sets ( 10 repetition) * Rest interval: 1min * Frequency: 3 times a week * Muscles included: Flexors(hip, knee, ankle), extensors(hip, knee, ankle), abductor(hip) and adductors(hip) 3. Gait training Parallel bar walking 4. Cuevas Medek Exercise(99 exercises) * Frequency: 3 times a week * Duration: 45mins * Repetition: 3-8 times * Exercises divided into following, will be administered according to patient need/goal; 1. Head control 2. Trunk control 3. Trunk and hip control 4. Coordination 5. Balance reaction 6. Stability |
| Interventional Group B | Active comparator | Procedure: Control GroupIt includes participants receiving conventional physical therapy for 12 weeks treatment. 1. Stretching Exercises (PNF stretching) * 0-6 weeks; 3 sets (5 repetition of 20sec) 4 times a week * 6-12 weeks; 3 sets(10 repetition of 60sec) 4 times a week * Muscles included: Flexors (hip, knee, ankle), extensors (hip, knee, ankle), abductor(hip) and adductors(hip) 2. Strengthening Exercises (Isometric muscle strengthening ) * 3 sets ( 10 repetition) * Rest interval: 1min * Frequency: 3 times a week * Muscles included: Flexors(hip, knee, ankle), extensors(hip, knee, ankle), abductor(hip) and adductors(hip) 3. Gait training Parallel bar walking Treatment time: 45mins |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- diagnosed spastic diplegic cerebral palsy children
- age group 6-12 years old
- both male and female
- GMFCS II \& III
- parents of spastic diplegic CP child
Key exclusion criteria (3 listed)
- diagnosed cognitive impairment
- diagnosed hearing impairment and visual impairment
- children with planned surgical procedures during study period
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 |
|---|---|---|
| Control GroupConventional Physical Therapy ( 12 weeks intervention) 24 randomly allocated participants will get the conventional physical therapy that includes the stretching exercises (PNF technique) for 6 weeks; targeting all the affected lower limb muscles, strengthening exercises of all the weak lower limb muscles for 12 weeks along with gait training on parallel bars. Duration of session is 45 min. | Procedure or surgery | Interventional Group B |
| Experimental GroupConventional Physical Therapy and Cuevas Medek Exercises ( 12 weeks intervention) 24 randomly allocated participants will get the conventional physical therapy that includes the stretching exercises (PNF technique) for 6 weeks; targeting all the affected lower limb muscles, strengthening exercises of all the weak lower limb muscles for 12 weeks along with gait training on parallel bars.Along with conventional physical therapy, experimental group participants will get Cuevas Medek Exercises that includes antigravity exercises, specefic types of stretchings and balancing exercises. Types of exercises that will be performed on the patient out of 100 exercises,will depend on the patient's need that is affecting his or her gross motor proficiency.Total duration of session is 90 min. | Procedure or surgery | Interventional Group A |
Primary outcome
Gross Motor Function
Time frame: 12 weeks
Gross Motor Function Measure-88 score, will be used to assess gross motor function in children with cerebral palsy. It is a four point scale, consists of 88 items divided into five dimensions of gross motor function: a. lying and rolling, b. crawling and kneeling, c. sitting, d. standing, e. walking, running and jumping. It takes about 45 to 60 minutes. Equipments required for this measure tool are; mat, bench, toy and access to stairs. Item scores are summed to calculate raw and percent scores for each of the five dimensions. Then, Average the percent scores for each dimension to get the total score. Total score (in percent), will be compared on each assessment to find out the improvement in the individual through that specefic intervention.
Quality of Life
Time frame: 12 weeks
CP QOL Child Primary Caregiver It is a validated questionnaire that assesses the subjective well- being and happiness of children with CP. It consist of 66 questions and should be answered by caregivers of CP child, who report their perception of their child's quality of life of areas: well being and social acceptance, functionality, participation and physical health, emotional well being and self esteem, access to services, pain and disability impact and family health. The questionnaire is scored by summing the items to get a total score, with higher scores representing better quality of life.
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 13 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Spastic Diplegia Cerebral Palsy and Quality of Lifte, run by Foundation University Islamabad 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 5 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: finished, as of the sponsor's last update on 13 May 2025. 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?
Gross Motor Function (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?
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 13 May 2025.