- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289347
Effect of a Light Stimulated Footsteps Pathway on Gait in Spastic Children
Effect of a Light Stimulated Footsteps Pathway on Kinematics of Gait in Spastic Diplegic Children
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Giza, Egypt
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
- Individuals undergoing radiation therapy or chemotherapy.
- Hepatic or pancreatic diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group (A)
This group of fifteen children received a regular traditional therapeutic exercise program three times per week for three month based on the Pragmatic approach .
|
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 |
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Experimental: Study Group (B)
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.
|
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 same routine program as the control group as well as 30 minutes of gait training on light stimulated footsteps pathway:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
At baseline and re assessed following 3 months
|
|
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)
|
At baseline and re assessed following 3 months
|
|
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. |
At baseline and re assessed following 3 months
|
|
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
|
At baseline and re assessed following 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012/006097
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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