- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04615793
Effect of Pilates Exercises on Gross Motor Function and Balance
June 13, 2021 updated by: hanaa mohsen, Badr University
Effect of Pilates Exercises on Gross Motor Function and Balance in Children With Diplegic Cerebral Palsy
the study aimed to asses the effect of Pilate exercise on motor function and balance in diplegic children
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
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
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Cairo, Egypt
- Badr Univesity in Cairo (BUC)
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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
7 years to 9 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 7 to 9 years,
- mild spasticity of lower limb
- able to understand and follow instructions
Exclusion Criteria:
- fixed contracture
- visual or respiratory disorders,
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: CONTROL GROUP
The control group will receive flexibility exercises and strength training focusing on the trunk and lower limb muscles, postural control exercise in different positions and different surfaces and general endurance training .
Control group will receive intervention in the form of five minutes warm up followed by 12 minutes of walking at their comfortable pace and concluded with a five minutes cool down
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Experimental: EXPERMINTAL GROUP
The experimental group will obtain Pilate exercises, consist of strengthening,stretching and coordinated exercises on lower and trunk muscle
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The experimental group will receive Pilates exercises focusing on lower limb strength, flexibility and coordination in addition to exercises given to control group.
Exercises or movements were done on a mat, on an exercise ball or in standing position while emphasizing on spinal and pelvic alignment, maintaining core contraction and the rhythm of respiration.
All exercises were done for 10 repetitions with a rest period of two minutes before commencing the next exercise, and lasted for about 45 minutes.
All the groups will receive the above mentioned interventions thrice in a week for a period of 10 week
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Pediatric Balance Scale
Time Frame: pre and after 10 week of intervention, the maximum score is 56, so increase the score indicate improvement
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The PBS is a modified version of the Berg balance scale, which is designed to evaluate balance in children with mild to moderate motor impairment.
Fifty-six points is the maximum score .
This scale evaluates performance of fourteen activities common in everyday life.
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pre and after 10 week of intervention, the maximum score is 56, so increase the score indicate improvement
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gross motor function
Time Frame: pre and after 10 week of intervension. increase the percentage indicate improvement
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gross motor function consist of 5 dimensions.
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pre and after 10 week of intervension. increase the percentage indicate improvement
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 3, 2020
Primary Completion (Actual)
January 1, 2021
Study Completion (Actual)
January 31, 2021
Study Registration Dates
First Submitted
October 28, 2020
First Submitted That Met QC Criteria
November 3, 2020
First Posted (Actual)
November 4, 2020
Study Record Updates
Last Update Posted (Actual)
June 15, 2021
Last Update Submitted That Met QC Criteria
June 13, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- P.T.REC/012/002914
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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.
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