- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07251751
Forward Versus Backward Gait Training on Functional Abilities in Children With Spastic Cerebral Palsy
Study Overview
Status
Conditions
Detailed Description
> Cerebral palsy is a common neurological disorder in children that affects movement and posture. Spastic cerebral palsy is characterized by muscle stiffness and impaired motor control, which limits the child's functional mobility.
Gait training is an essential part of rehabilitation programs for children with cerebral palsy. Previous studies have shown that both forward and backward walking can improve motor performance, but limited evidence exists comparing the two methods directly.
The present randomized clinical trial aims to compare the effects of forward gait training versus backward gait training on functional abilities in children with spastic cerebral palsy. Participants will be randomly assigned into three groups: group (A) will receive a designed physical therapy program. group (B) will receive the same program with forward gait training on treadmill. group (C) will receive the same designed physical therapy program beside backward gait training on treadmill three times weekly over three successive months.
Outcome measures will include muscle strength of measurements, range of motion of lower limb,gait pattern changes and gross motor function measurements.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Monoufia
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Shibīn al Kawm, Monoufia, Egypt
- El Shohadaa Central Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:1-All children will be spastic diplegic cerebral palsy. 2- Age will be ranged from 6-9 years old. 3. They will have spasticity grade 1 to 1+ according to Modified Ashwarth's Scale (Appendix II).
4. Both genders will be included. 5. Their gross motor function ability will be selected at level I, II according to Gross Motor Function Classification System (GMFCS).
6. They will be able to understand and follow verbal commands included in evaluation and training.
Exclusion Criteria:
1- Any surgical intervention in upper or lower limbs. 2¬- Any type of fracture. 3- Visual and/or auditory defects. 4- Other neurological conditions rather than CP. 5- Significant tightness or fixed deformity of lower limbs and spine. 6- Congenital heart disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group (designed physical therapy program)
participants will receive designed physical therapy exercises only
|
Participants receive traditional physical therapy exercises focusing on stretching, strengthening, and balance training for the same duration as the experimental groups.
|
|
Experimental: forward gait training
participants will receive designed physical therapy exercises beside forward gait training.
|
The training program consists of forward walking exercises conducted three times per week for three successive months under the supervision of a physical therapist.
|
|
Experimental: backward gait training
participants will receive designed physical therapy exercises beside backward gait training.
|
The training program consists of backward walking exercises conducted three times per week for three successive months under the supervision of a physical therapist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function Measure (GMFM-88) score
Time Frame: Baseline and after three months of intervention
|
The GMFM-88 will be used to assess changes in gross motor function in children with spastic cerebral palsy before and after the intervention.
Higher scores indicate better motor performance.
|
Baseline and after three months of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ramy A Khidr, PhD, El Shohadaa Central Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ramy Gait training in C.P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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