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NCT Number: NCT07686809

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.

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Key information

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

outpatient clinic faculty of physical therapy, Cairo University

Cairo, Egypt

Location status: Recruiting

Location contact

Mohamed Ali Taha

CONTACT

[email protected]

01022599920

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified Constraint-Induced Movement Therapy

Other

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

Conventional physical therapy

Other
  • Repetitive motor training following shaping task
  • Step on stool.
  • Squat to stand.
  • Pressing the pedal stepper.
  • Walking on treadmill.
  • Bicycle.
  • Air walker.
  • Behavioral strategies:
  • Walking with picking toys from ground
  • Passing obstacles
  • Walking with a ball, moving it by the lower extremity

Primary outcomes

  1. assessment of spatial gait parameters

    Time frame: At baseline and after Four weeks

    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.

Secondary outcomes

  1. assessment of Temporal gait parameters

    Time frame: At baseline and after four weeks

    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.

  2. assessment of the functional mobility

    Time frame: At baseline and after four weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Ali Taha

CONTACT

[email protected]

01022599920

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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