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RecruitingNCT06955052Updated May 2, 2025

The Effects Of "Minds In Motion The Maze" on Balance and Gate In Children With Down Syndrome

An interventional study of "Minds In Motion The Maze" and conventional treatment in Down Syndrome, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Riphah International University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Down Syndrome

Keywords

  • Down syndrome
  • Minds in Motion
  • Cognitive behavior
  • Therapeutic approaches
  • Quality of life
03

In context

Down Syndrome

432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.

This study's planned enrollment of 20 is below the median of 36 across 283 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Uncontrolled seizures
  • Any kind of orthopedic condition
  • Registered visually impaired
  • Atlanto Axial instability
  • Any chest infection
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    experimental group(MINDS IN MOTION THE MAZE)

    Clinical experimental: For group -mind in motion the maze at least for 7 weeks for 3 times per week during a period of 7 weeks intervention protocol : Balance board linear balance power skip jump rope tumble roll step ups midline touch

    Other: "Minds In Motion The Maze"

  • Active comparator
    control group ( conventional treatment)

    Document any specific motor challenges or deficits typical in children with down syndrome. walk for 10 to 20 minutes warm up for 5 minutes cool down for 5 minutes rest period as per the subject convenience 6 stretching exercise performed during the warm and cool down period ,standing with feet together, standing with feet shoulder apart sitting with feet together ,sitting with feet shoulder width apart standing with only on leg extended , sitting with only one leg standing extended

    Other: conventional treatment

Interventions

  • Other"Minds In Motion The Maze"

    "Minds in Motion the Maze" is a program that combines physical activity with cognitive training. Research suggests that MIM can positively impact balance and gait in children with Down syndrome. Some potential benefits include: * Improved balance and stability * Enhanced gross motor skills * Better coordination and overall physical function * Increased confidence in physical abilities The program's effectiveness may vary depending on individual needs and program implementation.

  • Otherconventional treatment

    Document any specific motor challenges or deficits typical in children with down syndrome. walk for 10 to 20 minutes warm up for 5 minutes cool down for 5 minutes rest period as per the subject convenience 6 stretching exercise performed during the warm and cool down period ,standing with feet together, standing with feet shoulder apart sitting with feet together ,sitting with feet shoulder width apart standing with only on leg extended , sitting with only one leg standing extended

06

What researchers measure

Primary outcomes

  1. Balance berg scale

    The Berg Balance Scale has been shown to have both high intra-rater and inter-rater reliability. Intra-rater reliability is when the same person who is administering the test can achieve the same results. Inter-rater reliability is when the test can be performed by different persons and achieve the same results. A systematic review conducted by Downs evaluated the Berg Balance Scale for individuals with various neurological conditions, including acute stroke, recent stroke, multiple sclerosis, cognitively impaired patients, and Parkinson disease patients, in different settings such as acute inpatient rehabilitation, outpatient rehabilitation, outpatient clinic, and home visits. The intra-rater relative reliability was found to be 0.98, with a 95% conference interval

    Time frame: 7 weeks

  2. Limits of stability test

    Limits of Stability (LoS) is a significant variable in assessing stability and voluntary motor control in dynamic states. It provides valuable information by tracking the instantaneous change in the center of mass (COM) velocity and position. LoS is a useful measure for evaluating postural instability and identifying individuals at higher risk of falling, making it a valuable screening tool. Test-retest reliability ranged from high to low across the 5 LOS measures (intraclass correlation coefficient \[2,k\] = 0.82 to 0.48). Pearson correlations revealed 4 significant relationships (P \< .05) between and within the 2 computerized posturography devices (r = 0.42 to -0.65)

    Time frame: 7 weeks

  3. GOAL Test

    The Goal-Oriented Assessment of Life skills (GOAL) is an innovative new evaluation of functional motor abilities needed for daily living. Designed for children 7 to 17, the GOAL consists of seven Activities, fun and motivating tasks based on real occupations of a child's daily life. Each activity is linked to Intervention Targets that help you turn assessment results into a specific, goal-oriented treatment plan. This standardized, psycho metrically precise instrument offers an ecologically valid description of a child's competencies and opportunities for growth in both fine and gross motor domains.

    Time frame: 7 weeks

  4. Timed up and Go test

    Timed Up and Go test (TUG) is a relatively simple test used to assess a person's mobility and requires both static and dynamic balance. The TUG is used frequently in the elderly population, as it is easy to administer and can generally be completed by most older adults has excellent inter-rater correlation (ICC) = 0.99, and high intra-rater reliability (ICC = 0.99

    Time frame: 7 weeks

07

Study locations

1 of 1 sites recruiting
  • Rising sun institute
    Lahore, Punjab 54900, Pakistan
    Recruiting
08

References and documents

Publications

  • 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. PubMed 32805715 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06955052
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
May 2, 2025
Start date
Apr 17, 2025
Primary completion
Jun 5, 2025 (estimated)
Completion
Jun 5, 2025 (estimated)
Last update
May 2, 2025

Study contacts

Imran Amjad, phd
Contact
imran.amjad@riphah.edu.pk
9233224390125
Muhammad Asif Javed, MS-PT
Contact
a.javed@riphah.edu.pk
923224209422
Wajeeha Saeed, MS-PPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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