NCT07686809

Brief Summary

  • 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jun 2026Aug 2026

First Submitted

Initial submission to the registry

May 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

May 29, 2026

Last Update Submit

July 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • assessment of Temporal gait parameters

    At baseline and after four weeks

  • assessment of the functional mobility

    At baseline and after four weeks

Study Arms (2)

Modified constraint induced movement therapy

EXPERIMENTAL

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 therapyOther: Conventional physical therapy

Conventional physical therapy

ACTIVE COMPARATOR

Fifteen children will receive conventional physical therapy program only for 1 hour 3 times per week for 4 weeks.

Other: Conventional physical therapy

Interventions

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

Modified constraint induced movement 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

Conventional physical therapyModified constraint induced movement therapy

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

outpatient clinic faculty of physical therapy, Cairo University

Cairo, Egypt

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 29, 2026

First Posted

July 7, 2026

Study Start

June 1, 2026

Primary Completion

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

July 7, 2026

Record last verified: 2026-07

Locations