- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06822296
Effect of Core Stability Training on Segmental Trunk Control and Quality of Life in Children with Cerebral Palsy
Effect of Core Stability Training on Segmental Trunk Control and Quality of Life in Children with Spastic Diplegia: a Randomized Controlled Trial
Spastic diplegia is a common shape of cerebral palsy that significantly affects trunk control and quality of life in children. Core stability training (CST) has been utilized as a potential intervention to improve the trunk function. This study investigated the effects of CST on segmental trunk control and quality of life in children with spastic diplegia.
Forty children with spastic diplegia (age: 3 - 6 years) were randomly assigned to either a control group (n=20) receiving a selected physical therapy program or an experimental group (n=20) receiving the same program plus a 30-minute CST program three times weekly for 12 weeks. Segmental trunk control was assessed using the Segmental Assessment of Trunk Control (SATCO) scale, and quality of life was measured using the Pediatric Quality of Life Inventory (PedsQL). Both outcome measures were evaluated pre- and post-intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo
-
Giza, Cairo, Egypt, 12613
- Faculty of physical therapy, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 3-6 years
- 1 to 1+ spasticity according to modified Ashworth scale
- level II and III according to GMFCs
- able to follow instructions and understand commands
Exclusion Criteria:
- significant visual or auditory problems
- fixed deformities
- Botox injection
- orthopedic surgery
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: Core Stability Training
receive an experimental intervention in form of functional exercises to improve core
|
Program of exercises to enhance function
|
|
Active Comparator: Traditional physical therapy
Traditional physical therapy used to treat the same condition
|
Exercises to improve function of children with CP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Segmental Assessment of Trunk Control scale
Time Frame: Baseline and after 12 weeks of training
|
Higher scores mean a better outcome.
Minimum Score: 0 (No control at any level) Maximum Score: 14 (Full control at all seven levels, each scoring 2)
|
Baseline and after 12 weeks of training
|
|
Quality of Life Inventory Scale
Time Frame: Baseline and after 12 weeks of training
|
Higher scores mean a better outcome.
Minimum Score: 0 (poorest quality of life) Maximum Score: 100 (best quality of life)
|
Baseline and after 12 weeks of training
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004816
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
product manufactured in and exported from the U.S.
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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