- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05316090
Effect of Core Stability Excercises Program on Reaching in Children With Cerebral Palsy
March 30, 2022 updated by: Mai Elsayed Abbass, Cairo University
Purpose of the study:
To evaluate effect of core stability exercises program on upper limb reaching in children with spastic hemiparetic cerebral palsy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Thirty spastic hemiparetic cerebral palsied children of both sexes will be selected from General hospitals and private centers in El-Minia government with the following criteria:
- The age of the selected children ranged from 3 To 6 years old.
- Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale
- Children in study group will be treated using core stability exercises program in addition to traditional program and children in the control group will be treated using traditional physical therapy program.
- Trunk control measurement scale and pediatric reach test will be used to evaluate each child individually before and after 6 successive weeks of treatment, three times per week.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11432
- Faculty of physical therapy, Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The age of the selected children ranged from 3 To 6 years old.
- Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale(Bohannon and Smith, 1987).
- Children with hemiparetic cerebral palsy
Exclusion Criteria:
1. Fructures and fixed deformities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: study group
Children in study group treated using core stability exercises program in addition to traditional program
|
Strengthening to the trunk muscles
Neurodevelopmental training excercises
|
|
Active Comparator: control group
Children in the control group treated using traditional physical therapy program.
|
Neurodevelopmental training excercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric reach test
Time Frame: assessment after 6 weeks of intervention
|
Reaching score
|
assessment after 6 weeks of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mai Abbass, Ph.D., Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2021
Primary Completion (Actual)
August 1, 2021
Study Completion (Actual)
August 8, 2021
Study Registration Dates
First Submitted
March 23, 2022
First Submitted That Met QC Criteria
March 30, 2022
First Posted (Actual)
April 7, 2022
Study Record Updates
Last Update Posted (Actual)
April 7, 2022
Last Update Submitted That Met QC Criteria
March 30, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.