CONSTRAINT-INDUCED MOVEMENT THERAPY VERSUS CROSS EDUCATION IN CHILDREN WITH CEREBRAL PALSY

Not Applicable

Not yet recruiting

• Conditions: Hemiplegic Cerebral Palsy

• Registration Number: NCT06704880
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

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.

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 Timeline

• Study First Submitted: 2024-09-09
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Study Start: 2024-11-30
• Primary Completion: 2025-02-28
• Study Completion: 2025-04-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Children with hemiplegic cerebral palsy aged age between 4 and 10.
2. (GMFCS) levels I, II and III.
3. Able to follow therapist instructions during training session.

Exclusion Criteria

1. Lack of patient's cooperation.
2. Difficulty wearing constraint method due to severe joint deformation or/and contracture.
3. Patients were treated with botulinum toxin during the last 3 months.
4. Seizure disorder not fully controlled by medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
gait speed	at base line then at the end of the 8 weeks	gait spatiotemporal parameter
cadence gait spatiotemporal parameter	at base line then at the end of the 8 weeks	gait spatiotemporal parameter
step length	at base line then at the end of the 8 weeks	gait spatiotemporal parameter
stride length	at base line then at the end of the 8 weeks	gait spatiotemporal parameter

Secondary Outcome Measures

Name	Time	Method
Pediatric balance scale	at base line then at the end of the 8 weeks	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.
6 Minute walk test (6MWT)	at base line then at the end of the 8 weeks	endurance measurement
Modified Ashworth scale	at base line then at the end of the 8 weeks	measuring muscle tone Scoring 0 No Increased in tone; 1. 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); 2. More marked increase in tone through most of the ROM, but the limb easily flexed; 3. Considerable increase in tone, passive movement difficult; 4. Limb rigid in flexion or extension
Handheld dynamometer	at base line then at the end of the 8 weeks	measuring muscles strength

Trial Locations

Locations (1)

Imam Abdulrahmn Alfaisal University; 🇸🇦 Dammam, Saudi Arabia