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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemiplegic Cerebral Palsy
• Intervention / Treatment: Other: rehabilitation

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: abdullah owaid Alanazi, PhD student; Phone Number: 800-555-5555; Email: aalanazi112@moh.gov.sa
• Study Contact Backup: Name: alaa ibrahim ismail, professor; Email: aiibrahim@iau.edu.sa

Study Locations

• Saudi Arabia
  • Dammam, Saudi Arabia
    • Imam Abdulrahmn Alfaisal University
    • Contact: abdullah owaid alanazi, PhD student; Phone Number: 00966503035285; Email: aalanazi112@moh.gov.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CIMT GROUP	Other: rehabilitation; 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
Experimental: STRENGHTH TRAINING GROUP (cross education)	Other: rehabilitation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at base line then at the end of the 8 weeks
6 Minute walk test (6MWT)	endurance measurement	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	at base line then at the end of the 8 weeks
Handheld dynamometer	measuring muscles strength	at base line then at the end of the 8 weeks

Collaborators and Investigators

• Sponsor: Imam Abdulrahman Bin Faisal University

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): April 29, 2025

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: IRB-PGS-2024-03-156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No