- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06955052
The Effects Of "Minds In Motion The Maze" on Balance and Gate In Children With Down Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54900
- Recruiting
- Rising Sun Institute
-
Contact:
- Muhammad Asif Javed, MS-PT(Neuro)
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
"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:
The program's effectiveness may vary depending on individual needs and program implementation. |
|
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 |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
7 weeks
|
|
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)
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7 weeks
|
|
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.
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7 weeks
|
|
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
|
7 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wajeeha Saeed, MS-PPT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/0746
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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