- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06927869
Pully System Exercise Role in Management of Spasticity
Effect of Pully System Exercise in Management of Spasticity in Cerebral Palsy Children: A Randomized Clinical Trial
The goal of this clinical trial is to investigate the effect of pully system exercise in in management of spasticity in cerebral palsy children
Does pully system exercise has role in management of spasticity in cerebral palsy children ?
Participants will:
The participants assigned to the control group will receive a standard care program. This program is designed to provide basic supportive therapies without the specialized pulley system exercises
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt
- Elsalam university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Inclusion criteria
- The degree of spasticity is (1) according to Modified Ashwarth's scale
- They able to understand orders given to them.
- All children evaluated before and after the suggested period of the physical therapy program (3months).
Exclusion Criteria:
- - No fixed deformities.
- They have neither visual nor auditory problems.
- They have neither perceptual nor cognitive problems.
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 |
|---|---|
|
Experimental: group 1
the l group will receive a standard care program.
|
Participants assigned to the intervention group will engage in a specially designed physical therapy program focusing on pulley system exercises.
The program is scheduled to occur three times per week, which is frequent enough to potentially induce meaningful improvements while allowing adequate rest between sessions to prevent fatigue and overtraining
|
|
Experimental: study
study group will received pulley system exercises
|
Participants assigned to the intervention group will engage in a specially designed physical therapy program focusing on pulley system exercises.
The program is scheduled to occur three times per week, which is frequent enough to potentially induce meaningful improvements while allowing adequate rest between sessions to prevent fatigue and overtraining
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gross motor function of children with cerebral palsy using GMFMS
Time Frame: 3 months
|
evaluate change that occurs over time in the gross motor function of children with cerebral palsy
|
3 months
|
|
pediatric balance scale
Time Frame: 3 months
|
A 14-item criterion-referenced measure that examines functional balance in the context of everyday tasks in the pediatric population.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
spasticity with EMG
Time Frame: 3 months
|
In assessing muscle tone it is important to consider all the inputs and outputs affecting it, using biomechanical-EMG techniques for measuring active tone
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
erobic capacity
Time Frame: 3 months
|
6m walk test
|
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 (Estimated)
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
- KFSIRB200-193
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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