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Recruiting NCT07686809

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

No phase Interventional Spastic Hemiplegic Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modified constraint-induced movement therapy, Conventional physical therapy.
Who it may be relevant to
Registry conditions: Spastic Hemiplegic Cerebral Palsy. Basic parameters: 6 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

* 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.

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.

Interventions

  • 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: 1. Walking with knee scooter forward on 8 meter walkway 2. Walking with knee scooter backward on 8 meter walkway 3. Standing with the knee scooter on balance board
  • Other Conventional physical therapy
    1. Repetitive motor training following shaping task * Step on stool. * Squat to stand. * Pressing the pedal stepper. * Walking on treadmill. * Bicycle. * Air walker. 2. Behavioral strategies: * Walking with picking toys from ground * Passing obstacles * Walking with a ball, moving it by the lower extremity

Primary outcome measures

  • assessment of spatial gait parameters [Time frame: At baseline and after Four weeks]
Secondary outcome measures (2)
  • assessment of Temporal gait parameters [Time frame: At baseline and after four weeks]
  • assessment of the functional mobility [Time frame: At baseline and after four weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • outpatient clinic faculty of physical therapy, Cairo University — Cairo

Identifiers

NCT: NCT07686809 · Mohamed Ali-PhD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗