- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07675343
Functional Progressive Resistive Training and Cerebral Palsy
Effect of Functional Progressive Resistance Training on Bone Mineral Density and Balance in Children With Cerebral Palsy
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alaa Alnemr
- Phone Number: +201003727467
- Email: alaaalnemr28@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A diagnosis of spastic diplegic CP
- Degree of spasticity ranges from 1+ and 2, according to modified Ashworth scale (MAS)
- The age of the selected children will range from 6 to 10 years old.
- Children are levels II and III according to GMFCS
Exclusion Criteria:
1 - Children with visual or auditory problems. 2. Children with severe intellectual disability (IQ less than 65 according to Stanford Binet intelligence scale).
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: designed physical therapy program
|
conventional physical therapy program including reinforcement of the normal motor development, reflex inhibiting patterns, postural reaction, stretching, strengthening exercises, and gait training was applied to children in the control group
|
|
Experimental: functional progressive resistive exercise and designed physical therapy program
|
specially designed physical therapy program in addition to functional progressive resistive exercises for 60 min (30 min designed P.T program and other 30 min for brain gym exercises), 3 sessions/ week for 3 successive months. 6 functional progressive resistive exercises will be selected:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dual-energy X-ray absorptiometry (DXA)
Time Frame: 3month
|
The most common test for bone mineral density is a Dual-energy X-ray absorptiometry (DXA) scan. It is: Painless and non-invasive Quick (usually 10-20 minutes) Low radiation exposure Most often performed on the hip and lower spine. Bone mineral density (BMD) is a measure of the amount of mineral (mainly calcium and phosphorus) present in a specific volume of bone. It reflects bone strength and is used to assess the risk of fractures and diagnose osteoporosis. |
3month
|
|
biodex balance system
Time Frame: 3 month
|
The Biodex Balance System is a computerized device used to assess and improve static and dynamic balance, postural stability, and neuromuscular control.
It consists of a movable platform that can be adjusted to different levels of stability, allowing clinicians and researchers to evaluate an individual's ability to maintain balance under varying conditions.
|
3 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
- P.T.REC/012/006023
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
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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