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

NCT ID: NCT06704880

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-04-29

Brief Summary

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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

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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

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Hemiplegic Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CIMT GROUP

Group Type EXPERIMENTAL

rehabilitation

Intervention Type OTHER

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

STRENGHTH TRAINING GROUP (cross education)

Group Type EXPERIMENTAL

rehabilitation

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role lead

Responsible Party

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Abdullah Owaid Kerdi Alanazi

PHYSIOTHERAPIST

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Imam Abdulrahmn Alfaisal University

Dammam, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Central Contacts

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abdullah owaid Alanazi, PhD student

Role: CONTACT

800-555-5555

alaa ibrahim ismail, professor

Role: CONTACT

Facility Contacts

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abdullah owaid alanazi, PhD student

Role: primary

00966503035285

Other Identifiers

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IRB-PGS-2024-03-156

Identifier Type: -

Identifier Source: org_study_id

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