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

NCT06955052 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/24/0746
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

  7 weeks

• 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)

  7 weeks

• 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.

  7 weeks

• 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

  7 weeks

Study Arms (2)

experimental group(MINDS IN MOTION THE MAZE)

EXPERIMENTAL

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"

control group ( conventional treatment)

ACTIVE COMPARATOR

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

"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.

experimental group(MINDS IN MOTION THE MAZE)

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

control group ( conventional treatment)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rising sun institute

Lahore, Punjab Province, 54900, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 32805715 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Wajeeha Saeed, MS-PPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, phd

CONTACT

9233224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: April 17, 2025
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)