Effect of Lower Extremity Modified Constraint-induced Movement Therapy on Locomotion in Children With Hemiplegia

• To determine the effect of modified constraint-induced movement therapy on spatial and temporal gait parameters in children with hemiplegia.
• To determine the effect of modified constraint-induced movement therapy on functional mobility in children with hemiplegia.

Study Overview

• Status: Recruiting
• Conditions: Spastic Hemiplegic Cerebral Palsy
• Intervention / Treatment: Other: Modified constraint-induced movement therapy; Other: Conventional physical therapy

Detailed Description

Children with spastic hemiplegic cerebral palsy experience longer gait cycles, slower walking speeds, and longer support phases compared to healthy children, with substantial joint angle differences noted during ground contact and stride buffering. Although most can achieve independent walking, they often exhibit poor motor coordination, resulting in short strides and high stride frequencies for speed maintenance. Modified constraint-induced movement therapy has been employed to enhance lower-extremity function, but its effectiveness on key ambulation aspects like gait speed and balance remains unclear. The reliance on the unaffected limb further impacts locomotive behavior, leading to stiff knee gait and reduced functional mobility. This study aims to explore the therapy's effects on locomotion in hemiplegic children.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Ali Taha; Phone Number: 01022599920; Email: dr.mo7amed.ali224@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • outpatient clinic faculty of physical therapy, Cairo University
    • Contact: Mohamed Ali Taha; Phone Number: 01022599920; Email: dr.mo7amed.ali224@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. The age of the selected children will range from 6 to 8 years old.
2. Degree of spasticity will range from 1+ to 2 according to the modified Ashworth scale.
3. The level of motor function of the children will be levels I-II according to the Gross Motor Function Classification System.
4. Participants will present a score between 41 to 56 points on the pediatric balance scale.
5. They will be able to follow instructions and understand commands.

Exclusion Criteria:

1. Bone and tendon lengthening surgeries within the last 6 months.
2. Lung and heart diseases and disorders.
3. Vision or hearing problems.
4. Children with fixed deformities in the lower extremity.
5. Children with epilepsy.
6. Recent intramuscular Botulinum toxin injection.

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: Modified constraint induced movement therapy; Fifteen children will receive a conventional physical therapy program for 1 hour and modified constraint-induced movement therapy for 30 minutes 3 times per week for 4 weeks.	Other: Modified constraint-induced movement therapy; Three tasks will be designed to be performed for 10 min each while using the knee scooter as a method of constraint-induced movement therapy The 3 tasks will be as follows: Walking with knee scooter forward on 8 meter walkway; Walking with knee scooter backward on 8 meter walkway; Standing with the knee scooter on balance board; Other: Conventional physical therapy; Repetitive motor training following shaping taskStep on stool.Squat to stand.Pressing the pedal stepper.Walking on treadmill.Bicycle.Air walker.; Behavioral strategies:Walking with picking toys from groundPassing obstaclesWalking with a ball, moving it by the lower extremity
Active Comparator: Conventional physical therapy; Fifteen children will receive conventional physical therapy program only for 1 hour 3 times per week for 4 weeks.	Other: Conventional physical therapy; Repetitive motor training following shaping taskStep on stool.Squat to stand.Pressing the pedal stepper.Walking on treadmill.Bicycle.Air walker.; Behavioral strategies:Walking with picking toys from groundPassing obstaclesWalking with a ball, moving it by the lower extremity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of spatial gait parameters	Kinovea is a free 2D motion analysis software that facilitates inexpensive, sensor-free video-based motion assessments suitable for clinical practice. Its reliability has been established for measuring cervical range of motion (ROM) in both sagittal and frontal planes, dominant wrist joint ROM, shoulder ROM, and ankle joint ROM during walking. Additionally, it effectively measures spatial gait parameters, including stride length, step length, and hip, knee, and ankle angles at initial contact and mid-swing stages of the gait cycle. Required tools for its use include a walking area, digital camera, adhesive skin marks, and a tripod.	At baseline and after Four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of Temporal gait parameters	Kinovea is a free 2D motion analysis software that utilizes inexpensive, sensor-free video-based techniques for clinical motion analysis. Its reliability is essential for assessing important psychometric properties, especially in measuring various range of motion (ROM) for cervical, shoulder, and ankle joints, as well as capturing gait parameters like stance and swing phases. Required tools for its use include a walking area, digital camera, adhesive skin marks, and a tripod.	At baseline and after four weeks
assessment of the functional mobility	The Gross Motor Function Measure (GMFM-88) is a reliable and valid assessment tool for measuring gross motor function in children with cerebral palsy, specifically focusing on standing (segment D) and walking/running (segment E). It is widely used in clinical and research settings to track changes over time or assess the impact of interventions. Due to its lengthy administration time, it is best used for annual or biannual evaluations or research studies, and testers should be well-versed in its use prior to administration.	At baseline and after four weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Mohamed Ali-PhD

Drug and device information, study documents

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