Down SyndromeNCT06955052
The Effects Of "Minds In Motion The Maze" on Balance and Gate In Children With Down Syndrome
A study testing "Minds In Motion The Maze" and conventional treatment in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- "Minds In Motion The Maze" and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Apr 2025to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Uncontrolled seizures
- Any kind of orthopedic condition
- Registered visually impaired
- Atlanto Axial instability
- Any chest infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Rising sun institute
Lahore, Punjab Province, 54900
Muhammad Asif Javed, MS-PT(Neuro), 923224209422, a.javed@riphah.edu.pk
About this study
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.
- Conditions
- Down Syndrome
- Being tested
- "Minds In Motion The Maze", conventional treatment
- Keywords
- Down syndrome, Minds in Motion, Cognitive behavior, Therapeutic approaches, Quality of life
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"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 treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start17 Apr 2025
- Primary completion5 Jun 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajeeha Saeed, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955052
- Sponsor's protocol ID
- REC/RCR&AHS/24/0746
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of "Minds In Motion The Maze" on Balance and Gate In Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06955052
- Acronym / sponsor ID
- REC/RCR&AHS/24/0746
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, Minds in Motion, Cognitive behavior, Therapeutic approaches, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 5 Jun 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group(MINDS IN MOTION THE MAZE) | Experimental | Other: "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 |
| control group ( conventional treatment) | Active comparator | Other: conventional treatmentDocument 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 |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Uncontrolled seizures
- Any kind of orthopedic condition
- Registered visually impaired
- Atlanto Axial instability
- Any chest infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Other | experimental group(MINDS IN MOTION THE MAZE) |
| conventional treatmentDocument 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 | control group ( conventional treatment) |
Primary outcome
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
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)
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 32805715Terson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wajeeha Saeed, MS-PPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Minds In Motion The Maze" and conventional treatment in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, phd (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance berg scale (time frame: 7 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06955052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.