CONSTRAINT-INDUCED MOVEMENT THERAPY VERSUS CROSS EDUCATION IN CHILDREN WITH CEREBRAL PALSY
NEUROLOGY
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.
1 other identifier
interventional
40
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2024
CompletedFirst Posted
Study publicly available on registry
November 26, 2024
CompletedStudy Start
First participant enrolled
November 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2025
CompletedNovember 26, 2024
November 1, 2024
3 months
September 9, 2024
November 25, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
gait speed
gait spatiotemporal parameter
at base line then at the end of the 8 weeks
cadence gait spatiotemporal parameter
gait spatiotemporal parameter
at base line then at the end of the 8 weeks
step length
gait spatiotemporal parameter
at base line then at the end of the 8 weeks
stride length
gait spatiotemporal parameter
at base line then at the end of the 8 weeks
Secondary Outcomes (4)
Pediatric balance scale
at base line then at the end of the 8 weeks
6 Minute walk test (6MWT)
at base line then at the end of the 8 weeks
Modified Ashworth scale
at base line then at the end of the 8 weeks
Handheld dynamometer
at base line then at the end of the 8 weeks
Study Arms (2)
CIMT GROUP
EXPERIMENTALSTRENGHTH TRAINING GROUP (cross education)
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imam Abdulrahmn Alfaisal University
Dammam, Saudi Arabia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHYSIOTHERAPIST
Study Record Dates
First Submitted
September 9, 2024
First Posted
November 26, 2024
Study Start
November 30, 2024
Primary Completion
February 28, 2025
Study Completion
April 29, 2025
Last Updated
November 26, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share