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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05769556
Other study ID # EG, KFS lab Research7
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date November 28, 2023

Study information

Verified date March 2024
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be conducted to detect the effect of brain gym exercises on postural stability in children with down syndrome .


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date November 28, 2023
Est. primary completion date November 28, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Brain Gym Exercises
Brain gym exercises is a collection of simple movements that function to stimulate the development of all parts of the brain synergistically.
Traditional physiotherapy
A Group of exercises

Locations

Country Name City State
Egypt Physical Therapy Kafr Ash Shaykh Kafrelshiekh

Sponsors (1)

Lead Sponsor Collaborator
Aliaa Altohamy Goda

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postural Stability we will use
Single leg stance TEST (SLS)
Timed up and Go Test ( TUG)
Paediatric Balance Scale (PBS)
3 months
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