NCT07289347

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?

Trial Health

75
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
0mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Sep 2025May 2026

Study Start

First participant enrolled

September 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2026

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Expected
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

December 4, 2025

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • step length

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

    At baseline and re assessed following 3 months

  • step width

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

    At baseline and re assessed following 3 months

  • spasticity

    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.

    At baseline and re assessed following 3 months

  • gross motor function

    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.

    At baseline and re assessed following 3 months

Study Arms (2)

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 .

Other: therapeutic exercise

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.

Other: therapeutic exerciseOther: gait training on light stimulated footsteps pathway

Interventions

Balance training from different positions. Weight shifting exercises by facilitation of single limb support while standing. Ascending and descending stairs. Gait training between parallel bars applied three times per week for three month

Group AGroup B

same routine program as the control group as well as 30 minutes of gait training on light stimulated footsteps pathway: 1. Walk on the light stimulated footsteps (Forward steps) 2. Walk on the light stimulated footsteps (backward steps) 3. Tandem gait over light yellow line applied three times per week for three month

Group B

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Individuals undergoing radiation therapy or chemotherapy.
  • Hepatic or pancreatic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of physical therapy

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

September 20, 2025

Primary Completion

April 27, 2026

Study Completion (Estimated)

May 20, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations