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Clinical Trials/NCT07289347
NCT07289347
Active, not recruiting
Not Applicable

Effect of a Light Stimulated Footsteps Pathway on Kinematics of Gait in Spastic Diplegic Children

Amira saad mohamed1 site in 1 country30 target enrollmentStarted: September 20, 2025Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Amira saad mohamed
Enrollment
30
Locations
1
Primary Endpoint
step length

Overview

Brief Summary

PURPOSE: The purpose of this study will be investigation of the effect oflight stimulated footsteps pathway on kinematics of gait in spastic diplegic children BACKGROUND: The goal of most therapy procedures for children with spastic cerebral palsy is to increase their walking abilities. Locomotor training usinglight stimulated footsteps pathwayhas been recommended for the rehabilitation of children with cerebral palsy in an effort to improve walking independence and gait speed.

HYPOTHESES: Walking on light stimulated footsteps pathway may not affect kinematics of gait in spastic diplegic children RESEARCH QUESTION: Does walking on light stimulated footsteps pathway have any effect onkinematics of gait in spastic diplegic children?

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
4 Years to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age will range between5 and 8 years old.
  • They had Grade 1 and 1+ hypertonia according to Modified Ashworth Scale (Bohannon and Smith, 1987)
  • Motor Classification System, they were at level I and II (GMFCS)
  • They will capable of following commands and comprehend them.
  • They will exhibit defective gait kinematics, which can be determined through gait kinematics evaluation.
  • All patients who will be enrolled to the study will have their informed consent.

Exclusion Criteria

  • Epilepsy history.
  • Taking any anti spastic drugs.
  • Both lower limbs had permanent deformity.
  • Surgical intervention history.
  • Have visual or auditory defects.
  • Chest infections or unstable cardiac status.
  • Infective skin conditions.
  • Markedly high or low blood pressure.
  • Individuals with cardiopulmonary conditions.
  • Individuals with any pelvic disease.

Arms & Interventions

Control Group (A)

Active Comparator

This group of fifteen children received a regular traditional therapeutic exercise program three times per week for three month based on the Pragmatic approach .

Intervention: therapeutic exercise (Other)

Study Group (B)

Experimental

The fifteen children in this group got the same therapeutic exercise program as the control group, as well as 30 minutes of gait training on light stimulated footsteps pathway three times per week for three month.

Intervention: therapeutic exercise (Other)

Study Group (B)

Experimental

The fifteen children in this group got the same therapeutic exercise program as the control group, as well as 30 minutes of gait training on light stimulated footsteps pathway three times per week for three month.

Intervention: gait training on light stimulated footsteps pathway (Other)

Outcomes

Primary Outcomes

step length

Time Frame: At baseline and re assessed following 3 months

kinovea software used to evaluate step length The unit of measurement for Step Length is centimeter (cm)

step width

Time Frame: At baseline and re assessed following 3 months

kinovea software used to evaluate step width The unit of measurement for Step width is centimeter (cm)

spasticity

Time Frame: At baseline and re assessed following 3 months

The Modified Ashworth Scale (MAS) used for evaluation MAS assigns a grade of spasticity from a 0-4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch.

gross motor function

Time Frame: At baseline and re assessed following 3 months

The Gross Motor Function Measure (GMFM) is a standardized tool used to assess changes in gross motor function in children, particularly those with cerebral palsy. The GMFM uses a four-point ordinal scale for scoring each item, where: 0: Does not initiate 1. Initiates (but does not complete) 2. Partially completes 3. Completes the task fully Scores can be summed to calculate raw and percent scores for each dimension and a total GMFM score.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Amira saad mohamed
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Amira saad mohamed

lecturer of physical therapy

Cairo University

Study Sites (1)

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