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NCT Number: NCT06955052

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

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rising sun institute

Lahore, Punjab Province, 54900, Pakistan

Location status: Recruiting

Location contact

Muhammad Asif Javed, MS-PT(Neuro)

CONTACT

[email protected]

923224209422

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Minds In Motion The Maze"

Other

"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.

conventional treatment

Other

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

Primary outcomes

  1. Balance berg scale

    Time frame: 7 weeks

    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

  2. Limits of stability test

    Time frame: 7 weeks

    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)

  3. GOAL Test

    Time frame: 7 weeks

    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.

  4. Timed up and Go test

    Time frame: 7 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, phd

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS-PT

CONTACT

[email protected]

923224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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