Spastic Hemiplegic Cerebral PalsyNCT07686809
Effect of Lower Extremity Modified Constraint-induced Movement Therapy on Locomotion in Children With Hemiplegia
A study testing Modified constraint-induced movement therapy and Conventional physical therapy in people with Spastic Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
To determine the effect of modified constraint-induced movement therapy on spatial and temporal gait parameters in children with hemiplegia. To determine the effect of modified constraint-induced movement therapy on functional mobility in children with hemiplegia. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Spastic Hemiplegic Cerebral Palsy
- What is being tested?
- Modified constraint-induced movement therapy and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 30 Aug 2026
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The age of the selected children will range from 6 to 8 years old.
- Degree of spasticity will range from 1+ to 2 according to the modified Ashworth scale.
- The level of motor function of the children will be levels I-II according to the Gross Motor Function Classification System.
- Participants will present a score between 41 to 56 points on the pediatric balance scale.
- They will be able to follow instructions and understand commands.
Who cannot join
- Bone and tendon lengthening surgeries within the last 6 months.
- Lung and heart diseases and disorders.
- Vision or hearing problems.
- Children with fixed deformities in the lower extremity.
- Children with epilepsy.
- Recent intramuscular Botulinum toxin injection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
outpatient clinic faculty of physical therapy, Cairo University
Cairo
Mohamed Ali Taha, 01022599920, dr.mo7amed.ali224@gmail.com
About this study
- To determine the effect of modified constraint-induced movement therapy on spatial and temporal gait parameters in children with hemiplegia.
- To determine the effect of modified constraint-induced movement therapy on functional mobility in children with hemiplegia.
Read the detailed description
Children with spastic hemiplegic cerebral palsy experience longer gait cycles, slower walking speeds, and longer support phases compared to healthy children, with substantial joint angle differences noted during ground contact and stride buffering. Although most can achieve independent walking, they often exhibit poor motor coordination, resulting in short strides and high stride frequencies for speed maintenance. Modified constraint-induced movement therapy has been employed to enhance lower-extremity function, but its effectiveness on key ambulation aspects like gait speed and balance remains unclear. The reliance on the unaffected limb further impacts locomotive behavior, leading to stiff knee gait and reduced functional mobility. This study aims to explore the therapy's effects on locomotion in hemiplegic children.
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Being tested
- Modified constraint-induced movement therapy, Conventional physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified constraint-induced movement therapyOther
Three tasks will be designed to be performed for 10 min each while using the knee scooter as a method of constraint-induced movement therapy
The 3 tasks will be as follows:
- Walking with knee scooter forward on 8 meter walkway
- Walking with knee scooter backward on 8 meter walkway
- Standing with the knee scooter on balance board
Conventional physical therapyOther
- Repetitive motor training following shaping task
- Step on stool.
- Squat to stand.
- Pressing the pedal stepper.
- Walking on treadmill.
- Bicycle.
- Air walker.
- Behavioral strategies:
- Walking with picking toys from ground
- Passing obstacles
- Walking with a ball, moving it by the lower extremity
| Study group | Role | What they receive |
|---|---|---|
| Modified constraint induced movement therapy | Experimental | Fifteen children will receive a conventional physical therapy program for 1 hour and modified constraint-induced movement therapy for 30 minutes 3 times per week for 4 weeks. Receives: Other: Modified constraint-induced movement therapy; Other: Conventional physical therapy |
| Conventional physical therapy | Active comparator | Fifteen children will receive conventional physical therapy program only for 1 hour 3 times per week for 4 weeks. Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of spatial gait parameters
Kinovea is a free 2D motion analysis software that facilitates inexpensive, sensor-free video-based motion assessments suitable for clinical practice. Its reliability has been established for measuring cervical range of motion (ROM) in both sagittal and frontal planes, dominant wrist joint ROM, shoulder ROM, and ankle joint ROM during walking. Additionally, it effectively measures spatial gait parameters, including stride length, step length, and hip, knee, and ankle angles at initial contact and mid-swing stages of the gait cycle. Required tools for its use include a walking area, digital camera, adhesive skin marks, and a tripod.
Measured: At baseline and after Four weeks
Secondary outcomes (2)
assessment of Temporal gait parameters
Kinovea is a free 2D motion analysis software that utilizes inexpensive, sensor-free video-based techniques for clinical motion analysis. Its reliability is essential for assessing important psychometric properties, especially in measuring various range of motion (ROM) for cervical, shoulder, and ankle joints, as well as capturing gait parameters like stance and swing phases. Required tools for its use include a walking area, digital camera, adhesive skin marks, and a tripod.
Measured: At baseline and after four weeks
assessment of the functional mobility
The Gross Motor Function Measure (GMFM-88) is a reliable and valid assessment tool for measuring gross motor function in children with cerebral palsy, specifically focusing on standing (segment D) and walking/running (segment E). It is widely used in clinical and research settings to track changes over time or assess the impact of interventions. Due to its lengthy administration time, it is best used for annual or biannual evaluations or research studies, and testers should be well-versed in its use prior to administration.
Measured: At baseline and after four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jun 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali Elsayed Taha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686809
- Sponsor's protocol ID
- Mohamed Ali-PhD
- Status last verified
- Jul 2026
- First submitted
- 29 May 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lower Extremity Modified Constraint-induced Movement Therapy on Locomotion in Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT07686809
- Acronym / sponsor ID
- Mohamed Ali-PhD
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 7 Jul 2026 (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.
- To determine the effect of modified constraint-induced movement therapy on spatial and temporal gait parameters in children with hemiplegia.
- To determine the effect of modified constraint-induced movement therapy on functional mobility in children with hemiplegia.
Detailed description
Children with spastic hemiplegic cerebral palsy experience longer gait cycles, slower walking speeds, and longer support phases compared to healthy children, with substantial joint angle differences noted during ground contact and stride buffering. Although most can achieve independent walking, they often exhibit poor motor coordination, resulting in short strides and high stride frequencies for speed maintenance. Modified constraint-induced movement therapy has been employed to enhance lower-extremity function, but its effectiveness on key ambulation aspects like gait speed and balance remains unclear. The reliance on the unaffected limb further impacts locomotive behavior, leading to stiff knee gait and reduced functional mobility. This study aims to explore the therapy's effects on locomotion in hemiplegic children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified constraint induced movement therapy | Experimental | Other: Modified constraint-induced movement therapy, Other: Conventional physical therapyFifteen children will receive a conventional physical therapy program for 1 hour and modified constraint-induced movement therapy for 30 minutes 3 times per week for 4 weeks. |
| Conventional physical therapy | Active comparator | Other: Conventional physical therapyFifteen children will receive conventional physical therapy program only for 1 hour 3 times per week for 4 weeks. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The age of the selected children will range from 6 to 8 years old.
- Degree of spasticity will range from 1+ to 2 according to the modified Ashworth scale.
- The level of motor function of the children will be levels I-II according to the Gross Motor Function Classification System.
- Participants will present a score between 41 to 56 points on the pediatric balance scale.
- They will be able to follow instructions and understand commands.
Key exclusion criteria (6 listed)
- Bone and tendon lengthening surgeries within the last 6 months.
- Lung and heart diseases and disorders.
- Vision or hearing problems.
- Children with fixed deformities in the lower extremity.
- Children with epilepsy.
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 |
|---|---|---|
| Modified constraint-induced movement therapyThree tasks will be designed to be performed for 10 min each while using the knee scooter as a method of constraint-induced movement therapy The 3 tasks will be as follows: 1. Walking with knee scooter forward on 8 meter walkway 2. Walking with knee scooter backward on 8 meter walkway 3. Standing with the knee scooter on balance board | Other | Modified constraint induced movement therapy |
| Conventional physical therapy1. Repetitive motor training following shaping task * Step on stool. * Squat to stand. * Pressing the pedal stepper. * Walking on treadmill. * Bicycle. * Air walker. 2. Behavioral strategies: * Walking with picking toys from ground * Passing obstacles * Walking with a ball, moving it by the lower extremity | Other | Conventional physical therapy, Modified constraint induced movement therapy |
Primary outcome
assessment of spatial gait parameters
Time frame: At baseline and after Four weeks
Kinovea is a free 2D motion analysis software that facilitates inexpensive, sensor-free video-based motion assessments suitable for clinical practice. Its reliability has been established for measuring cervical range of motion (ROM) in both sagittal and frontal planes, dominant wrist joint ROM, shoulder ROM, and ankle joint ROM during walking. Additionally, it effectively measures spatial gait parameters, including stride length, step length, and hip, knee, and ankle angles at initial contact and mid-swing stages of the gait cycle. Required tools for its use include a walking area, digital camera, adhesive skin marks, and a tripod.
2 secondary outcomes
assessment of Temporal gait parameters
Time frame: At baseline and after four weeks
assessment of the functional mobility
Time frame: At baseline and after four weeks
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 7 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified constraint-induced movement therapy and Conventional physical therapy in people with Spastic Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
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 6 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 7 Jul 2026. 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 Egypt. 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 Mohamed Ali Taha (01022599920, dr.mo7amed.ali224@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of spatial gait parameters (time frame: At baseline and after Four weeks). 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 7 Jul 2026.