NCT05769556

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2023

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 3, 2023

Last Update Submit

March 7, 2024

Conditions

Keywords

Brain Gym ExercisesPostural Stability

Outcome Measures

Primary Outcomes (1)

  • Postural Stability

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

    3 months

Study Arms (2)

Group A

EXPERIMENTAL

will receive brain gym exercises and physiotherapy .

Other: Brain Gym Exercises

Group (B)

ACTIVE COMPARATOR

will receive physiotherapy alone.

Other: Traditional physiotherapy

Interventions

Brain gym exercises is a collection of simple movements that function to stimulate the development of all parts of the brain synergistically.

Group A

A Group of exercises

Group (B)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy

Kafr ash Shaykh, Kafrelshiekh, Egypt

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 15, 2023

Study Start

May 1, 2023

Primary Completion

November 28, 2023

Study Completion

November 28, 2023

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations