- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05769556
Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Evaluation procedures:
History of the patients was carefully taken to collect data about their general conditions, physical activity and current medication. The procedures of this study were divided in the following main parts:
-Preparatory Procedures:
- All medical and demographic data of subjects will be collected
- The role of physical therapy importance in improving their life will be explained.
- The basic vital signs of all patients will be monitored (BP, temperature, respiratory rate, and HR).
- The patients will be instructed to report any side effects during the treatment sessions .
explained to the children and to their parents, before conducting the study. All the participants were screened (examined) according to inclusion and exclusion criteria. then met the parents of the participants, told them about the study, and received a written approval from them .
All the children were firstly screened for balance deficit (static , dynamic and functional balance) by using
- Single leg stance Test (SLS) for static balance assessment
- Timed up and Go Test (TUG) for dynamic balance assessment
Paediatric Balance Scale (PBS) for functional balance assessment
- the assessment and the treatment program, were conducted for each child individually, before and after the treatment period.
assessment :
- Single leg stance Test (SLS) for static balance assessment
- Timed up and Go Test (TUG) for dynamic balance assessment
- Paediatric Balance Scale (PBS) for functional balance assessment
TTT :
Group A will receive brain gym exercises and physiotherapy, while Group (B) will receive physiotherapy alone.
brain gym exercises will be applied for 12 weeks , 3 per week .
Therapist Will ask the child to drink a cup of water ,then investigators apply these exercises :
Cross Crawl - Elephant - Belly breathing -The owl - Arm activation -positive points - Energizer - foot flex - neck rolls -the grounder -Brain Buttons -Hook Up Sitting position - Thinking Caps- Lazy Eights - The Rocker-Calf pump - The gravity glider exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aliaa Al Goda, bachelor's
- Phone Number: +20 01142141734
- Email: aliaatohamey@gmail.com
Study Locations
-
-
Kafrelshiekh
-
Kafr Ash Shaykh, Kafrelshiekh, Egypt
- Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-
Child characteristics:
- Their age ranged from six to twelve years.
- Both genders will be included.
- ALL children were mentally sub-normal and they were able to understand the command that will give to them (IQ ranged from 60 - 70) according to the national research centre reports.
- Their weight and height will be within normal ranges.
- They were able to stand on the balance check system and maintain stability on it.
Exclusion Criteria:
hildren with DS, who might have one or more of the following will be excluded:
- Children with severe mental retardation.
- Children who have any associated disorders or any congenital abnormalities that may affect balance.
- Children with visual defects that can affect their performance.
- Obese children.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
will receive brain gym exercises and physiotherapy .
|
Brain gym exercises is a collection of simple movements that function to stimulate the development of all parts of the brain synergistically.
|
Active Comparator: Group (B)
will receive physiotherapy alone.
|
A Group of exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postural Stability
Time Frame: 3 months
|
we will use
|
3 months
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EG, KFS lab Research7
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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