Hemiplegic Cerebral PalsyNEUROLOGYNCT06704880
CONSTRAINT-INDUCED MOVEMENT THERAPY VERSUS CROSS EDUCATION IN CHILDREN WITH CEREBRAL PALSY
A study testing rehabilitation in people with Hemiplegic Cerebral Palsy, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
This clinical trial aims to Compare the effectiveness of lower limb CIMT and the Strength Training of the Non-Hemiplegic lower limb on motor performance in hemiplegic children with CP. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Nov 2024to 29 Apr 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with hemiplegic cerebral palsy aged age between 4 and 10.
- (GMFCS) levels I, II and III.
- Able to follow therapist instructions during training session.
Who cannot join
- Lack of patient's cooperation.
- Difficulty wearing constraint method due to severe joint deformation or/and contracture.
- Patients were treated with botulinum toxin during the last 3 months.
- Seizure disorder not fully controlled by medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
alaa ibrahim ismail, professor contact
Saudi Arabia1 site
Imam Abdulrahmn Alfaisal University
Dammam
abdullah owaid alanazi, PhD student, 00966503035285, aalanazi112@moh.gov.sa
About this study
Official title: Lower Limb Constraint-induced Movement Training Versus Strength Training of the Non-hemiplegic Lower Limb on Motor Performance in Children With Hemiplegic Cerebral Palsy: A Randomized Control Trial.
This clinical trial aims to Compare the effectiveness of lower limb CIMT and the Strength Training of the Non-Hemiplegic lower limb on motor performance in hemiplegic children with CP.
Participants will:
diagnosed with hemiplegic cerebral palsy treated with CIMT or Strength training (cross-education) for a non-hemiplegic limb for 8 weeks.
3 sessions per week. Measurements will be taken at baseline and then at the end of the 8 weeks.
Read the detailed description
Method:
32 children with hemiplegic CP will be equally and randomly allocated to two groups (group A and B). group A will receive lower limb CIMT for the non- hemiplegic limb using whole leg orthosis and Group B will receive strengthen training for the non-hemiplegic lower limb. Both groups will receive routine physical therapy for the hemiplegic lower limb. Both groups will receive 60 minutes training session for 3 sessions per week for 8 consecutive weeks. Assessment will be at baseline then at the end of trial.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitationOther
children in the CIMT group will RECIEVE lower limb CIMT for the non-hemiplegic limb using whole leg orthosis. Children in cross-education group will receive strengthening training for the non-hemiplegic lower limb
| Study group | Role | What they receive |
|---|---|---|
| CIMT GROUP | Experimental | Not described Receives: Other: rehabilitation |
| STRENGHTH TRAINING GROUP (cross education) | Experimental | Not described Receives: Other: rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait speed
gait spatiotemporal parameter
Measured: at base line then at the end of the 8 weeks
cadence gait spatiotemporal parameter
gait spatiotemporal parameter
Measured: at base line then at the end of the 8 weeks
step length
gait spatiotemporal parameter
Measured: at base line then at the end of the 8 weeks
stride length
gait spatiotemporal parameter
Measured: at base line then at the end of the 8 weeks
Secondary outcomes (4)
Pediatric balance scale
Pediatric balance scale The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: at base line then at the end of the 8 weeks
6 Minute walk test (6MWT)
endurance measurement
Measured: at base line then at the end of the 8 weeks
Modified Ashworth scale
measuring muscle tone Scoring 0 No Increased in tone
- Slight increase in tone giving a catch when the limb is moved in flexion or extension 1+ Slight increase in muscle tone, indicated by a catch followed by minimal resistance throughout range of motion (ROM)
- More marked increase in tone through most of the ROM, but the limb easily flexed
- Considerable increase in tone, passive movement difficult
- Limb rigid in flexion or extension
Measured: at base line then at the end of the 8 weeks
Handheld dynamometer
measuring muscles strength
Measured: at base line then at the end of the 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start30 Nov 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion29 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Owaid Kerdi Alanazi, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704880
- Sponsor's protocol ID
- IRB-PGS-2024-03-156
- Acronym
- NEUROLOGY
- Status last verified
- Nov 2024
- First submitted
- 9 Sep 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb Constraint-induced Movement Training Versus Strength Training of the Non-hemiplegic Lower Limb on Motor Performance in Children With Hemiplegic Cerebral Palsy: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT06704880
- Acronym / sponsor ID
- NEUROLOGY / IRB-PGS-2024-03-156
- Conditions
- Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 29 Apr 2025 (estimated)
- First posted
- 26 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.
This clinical trial aims to Compare the effectiveness of lower limb CIMT and the Strength Training of the Non-Hemiplegic lower limb on motor performance in hemiplegic children with CP.
Participants will:
diagnosed with hemiplegic cerebral palsy treated with CIMT or Strength training (cross-education) for a non-hemiplegic limb for 8 weeks.
3 sessions per week. Measurements will be taken at baseline and then at the end of the 8 weeks.
Detailed description
Method:
32 children with hemiplegic CP will be equally and randomly allocated to two groups (group A and B). group A will receive lower limb CIMT for the non- hemiplegic limb using whole leg orthosis and Group B will receive strengthen training for the non-hemiplegic lower limb. Both groups will receive routine physical therapy for the hemiplegic lower limb. Both groups will receive 60 minutes training session for 3 sessions per week for 8 consecutive weeks. Assessment will be at baseline then at the end of trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIMT GROUP | Experimental | Other: rehabilitation |
| STRENGHTH TRAINING GROUP (cross education) | Experimental | Other: rehabilitation |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with hemiplegic cerebral palsy aged age between 4 and 10.
- (GMFCS) levels I, II and III.
- Able to follow therapist instructions during training session.
Key exclusion criteria (4 listed)
- Lack of patient's cooperation.
- Difficulty wearing constraint method due to severe joint deformation or/and contracture.
- Patients were treated with botulinum toxin during the last 3 months.
- Seizure disorder not fully controlled by medication.
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 |
|---|---|---|
| rehabilitationchildren in the CIMT group will RECIEVE lower limb CIMT for the non-hemiplegic limb using whole leg orthosis. Children in cross-education group will receive strengthening training for the non-hemiplegic lower limb | Other | CIMT GROUP, STRENGHTH TRAINING GROUP (cross education) |
Primary outcome
gait speed
Time frame: at base line then at the end of the 8 weeks
gait spatiotemporal parameter
cadence gait spatiotemporal parameter
Time frame: at base line then at the end of the 8 weeks
gait spatiotemporal parameter
step length
Time frame: at base line then at the end of the 8 weeks
gait spatiotemporal parameter
stride length
Time frame: at base line then at the end of the 8 weeks
gait spatiotemporal parameter
4 secondary outcomes
Pediatric balance scale
Time frame: at base line then at the end of the 8 weeks
6 Minute walk test (6MWT)
Time frame: at base line then at the end of the 8 weeks
Modified Ashworth scale
Time frame: at base line then at the end of the 8 weeks
Handheld dynamometer
Time frame: at base line then at the end of the 8 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 26 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Hemiplegic Cerebral Palsy
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Active, not recruiting
Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
Children With Hemiplegic cp
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
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.
alaa ibrahim ismail, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation in people with Hemiplegic Cerebral Palsy, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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: opening soon, as of the sponsor's last update on 26 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 Saudi Arabia. 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 abdullah owaid Alanazi, PhD student (800-555-5555, aalanazi112@moh.gov.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait speed (time frame: at base line then at the end of the 8 weeks). The study lists 4 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 26 Nov 2024.