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Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome

Primary Purpose

Down Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Brain Gym Exercises
Traditional physiotherapy
Sponsored by
Aliaa Altohamy Goda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Brain Gym Exercises, Postural Stability

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group (B)

Arm Description

will receive brain gym exercises and physiotherapy .

will receive physiotherapy alone.

Outcomes

Primary Outcome Measures

Postural Stability
we will use Single leg stance TEST (SLS) Timed up and Go Test ( TUG) Paediatric Balance Scale (PBS)

Secondary Outcome Measures

Full Information

First Posted
March 3, 2023
Last Updated
July 5, 2023
Sponsor
Aliaa Altohamy Goda
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1. Study Identification

Unique Protocol Identification Number
NCT05769556
Brief Title
Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome
Official Title
Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
July 28, 2023 (Anticipated)
Study Completion Date
October 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aliaa Altohamy Goda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Brain Gym Exercises, Postural Stability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
will receive brain gym exercises and physiotherapy .
Arm Title
Group (B)
Arm Type
Active Comparator
Arm Description
will receive physiotherapy alone.
Intervention Type
Other
Intervention Name(s)
Brain Gym Exercises
Intervention Description
Brain gym exercises is a collection of simple movements that function to stimulate the development of all parts of the brain synergistically.
Intervention Type
Other
Intervention Name(s)
Traditional physiotherapy
Intervention Description
A Group of exercises
Primary Outcome Measure Information:
Title
Postural Stability
Description
we will use Single leg stance TEST (SLS) Timed up and Go Test ( TUG) Paediatric Balance Scale (PBS)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aliaa Al Goda, bachelor's
Phone
01142141734
Ext
+20
Email
aliaatohamey@gmail.com
Facility Information:
Facility Name
Physical Therapy
City
Kafr Ash Shaykh
State/Province
Kafrelshiekh
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome

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