Clinical trial NCT06955052: The Effects Of "Minds In Motion The Maze" on Balance and Gate In Children With Down Syndrome
Official title: The Effects Of "Minds In Motion The Maze" on Balance and Gate In Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Down syndrome
Minds in Motion
Cognitive behavior
Therapeutic approaches
Quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be randomized controlled trial. Total 20__ subjects will be assigned by non probability convenient sampling technique. They were randomly assigned to experimental and control groups. The Berg balance scale, limits of stability test, GOAL test, Timed up and go tools will be used. Tests will be used as outcome measure tools for balance, walk, coordination and Physical activity. All measures will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0 version. If data will be normally distributed then parametric if not normally distributed than non-parametric test will be apply.
Primary purpose: OTHER

Brief summary: This study explores the impact of "Minds In Motion: The Maze" on balance and gait in children with Down syndrome-a population often facing motor and coordination challenges. A randomized controlled trial will be conducted with 20 participants selected through non-probability convenience sampling and randomly assigned to experimental and control groups. The intervention group will engage in the "Minds In Motion: The Maze" program, designed to enhance motor skills through interactive activities. Balance and gait will be assessed using the Berg Balance Scale, Limits of Stability Test, GOAL Test, and Timed Up and Go test at baseline and post-intervention. Data will be analyzed using SPSS version 25.0, applying parametric or non-parametric tests based on distribution. Qualitative feedback from participants, parents, and instructors will also be gathered to assess the program's broader impact. This research aims to inform therapeutic strategies to improve motor function and independence in children with Down syndrome.

Detailed description: This project aims to explore the effects of "Minds In Motion: The Maze" on the balance and gait of children diagnosed with Down syndrome. Down syndrome is a genetic disorder characterized by cognitive delays and physical challenges, including issues with balance and gait. "Minds In Motion: The Maze" is a specialized program designed to engage children in dynamic, interactive activities that target motor skills, coordination, and cognitive functions. The study will involve a sample of children diagnosed with Down syndrome, who will participate in the "Minds In Motion: The Maze" program for a specified duration. Their balance and gait will be assessed before and after the intervention using standardized tests and observational measures. Additionally, qualitative feedback from participants, parents, and instructors will be collected to gain insights into the perceived impact of the program. By investigating the effects of "Minds In Motion: The Maze" on balance and gait in children with Down syndrome, this research aims to contribute to the existing knowledge on interventions for enhancing motor skills and overall functioning in this population. The findings have the potential to inform the development of tailored therapeutic approaches to address the specific needs of children with Down syndrome, ultimately improving their quality of life and functional independence.

The study will be randomized controlled trial. Total 20__ subjects will be assigned by non probability convenient sampling technique. They were randomly assigned to experimental and control groups. The Berg balance scale, limits of stability test, GOAL test, Timed up and go tools will be used. Tests will be used as outcome measure tools for balance, walk, coordination and Physical activity. All measures will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0 version. If data will be normally distributed then parametric if not normally distributed than non-parametric test will be apply.

Eligibility criteria: Inclusion Criteria:

* Age group from 8 to 12 years
* Both male and female
* Children must have the physical and cognitive ability to engage in the activities
* Children should be in generally good health, without severe medical conditions or orthopedic issues
* Family consents

Exclusion Criteria:

* Uncontrolled seizures
* Any kind of orthopedic condition
* Registered visually impaired
* Atlanto Axial instability
* Any chest infection

Primary outcomes:
measure: Balance berg scale
timeFrame: 7 weeks
measure: Limits of stability test
timeFrame: 7 weeks
measure: GOAL Test
timeFrame: 7 weeks
measure: Timed up and Go test
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Rising sun institute
state: Punjab
Study officials:
affiliation: Riphah International University
name: Wajeeha Saeed, MS-PPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terson de Paleville DGL, Immekus JC. A Randomized Study on the Effects of Minds in Motion and Yoga on Motor Proficiency and Academic Skills Among Elementary School Children. J Phys Act Health. 2020 Aug 15;17(9):907-914. doi: 10.1123/jpah.2019-0454.