- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07578896
Maze Balance Board Training Effects on Mobility and Motor Skills in Cognitively Impaired Children
Effects of Maze Balance Board Training on Functional Mobility and Gross Motor Skills in Children With Cognitive Impairment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Difficulties with Functional Mobility, Gross and fine motor skills are common in children with Cognitive Impairment, significantly impacting their ability to perform everyday activities and acquire new motor skills. These difficulties often arise from impaired integration of sensory information and deficits in motor planning, resulting in poor functional mobility and increased risk of instability. As a result, affected children may struggle with maintaining upright positions, transitioning between movements, and executing coordinated actions, all of which are essential for functional mobility and participation in age-appropriate activities. To address these concerns, this study will assess the effects of Maze Balance Board Training on Functional Mobility and Gross Motor Skills in Children with Cognitive Impairment.
The study design will be a Randomized Controlled Trial. The study will recruit 22 children aged 6-10 years with identified deficits in Functional Mobility and Gross motor skills.
Participants will be randomly assigned to either the experimental group (n=11) which will follow a seven-stage progressive Maze Balance board protocol, and a control group (n=11) receiving standard Conventional physical therapy exercises. These interventions will be performed for 30 mins, thrice a week over 8 weeks. All the referred participants will be assessed on the basis of eligibility criteria. Guardians of participants fulfilling the eligibility criteria will be asked to sign the consent forms before entering them to study. This study will utilize three standardized assessment tools to objectively measure Cognition level, Functional Mobility and gross motor skills in children with Cognitive Impairment: Montreal Cognitive Assessment (MoCA) to measure cognition, Time Up and Go (TUG) Test for the functional mobility, While the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for Gross Motor Skills. The synopsis will be presented to the Research Ethical Committee of Riphah International University, Lahore, for ethical approval to conduct this study. Data will be analyzed through SPSS version 27.0.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Asif Javed
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Contact Backup
- Name: Imran Amjad, MS-PT
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab Province
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Lahore, Punjab Province, Pakistan, 05450
- Recruiting
- Imran Amjad, PhD
-
Contact:
- IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
-
Contact:
- Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
-
Principal Investigator:
- Maryam Shafique, MS-PT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 6-10 years
- Mild to Moderate Cognitive Impairment (MoCA score =18 to 25)
- Gross motor skill delay (10).
- Ability to follow verbal instructions
- Parents are willing to make sure their child's participation
Exclusion Criteria:
- Use of medications that may influence neuromotor functions (e.g., sedatives, antiepileptic's)
- Children with visual and hearing impairments
- Receiving concurrent therapies
- Recent lower limb injuries , surgeries, or musculoskeletal conditions
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: Maze Balance Board Training
The experimental group (n=11) will receive Maze Balance Board Training in a one-on-one setting, conducted three times per week for 8 weeks.
A seven-stage progressive protocol will be followed, where participants advance only after successfully completing each stage, with earlier stages revisited to reinforce learning.
Stage 1 involves rotating a marble with hands; Stage 2 focuses on manual maze navigation; Stage 3 develops static balance on a board; Stage 4 includes unassisted rotational balance; Stage 5 introduces foot-mediated marble rotation; Stage 6 requires foot-based maze navigation; and Stage 7 combines dynamic balance with precise marble placement as a dual task.
Progression will depend on task performance over consecutive days, aiming to improve functional mobility and gross motor skills in children with cognitive impairment.
|
The experimental group (n=11) will receive Maze Balance Board Training in a one-on-one setting, conducted three times per week for 8 weeks.
A seven-stage progressive protocol will be followed, where participants advance only after successfully completing each stage, with earlier stages revisited to reinforce learning.
Stage 1 involves rotating a marble with hands; Stage 2 focuses on manual maze navigation; Stage 3 develops static balance on a board; Stage 4 includes unassisted rotational balance; Stage 5 introduces foot-mediated marble rotation; Stage 6 requires foot-based maze navigation; and Stage 7 combines dynamic balance with precise marble placement as a dual task.
Progression will depend on task performance over consecutive days, aiming to improve functional mobility and gross motor skills in children with cognitive impairment.
|
|
Other: Conventional Physical Therapy
The control group (n=11) will receive conventional physical therapy as a standard-of-care baseline, conducted to improve postural control and gross motor skills.
Sessions will include structured exercises performed regularly throughout the study.
Activities include animal walks (bear walk, bunny hops, frog jumps) to enhance core and limb strength; bridging exercises to strengthen glutes and hamstrings; sit-to-stand training to improve lower limb strength and functional movement; tandem walking to challenge balance; standing on varied surfaces (foam/cushions) to improve proprioception; beam/line walking forward and backward for coordination and dynamic balance; and obstacle negotiation involving stepping over or around objects.
These exercises will be consistently practiced to enhance mobility and motor performance in children with cognitive impairment.
|
The control group (n=11) will receive conventional physical therapy as a standard-of-care baseline, conducted to improve postural control and gross motor skills.
Sessions will include structured exercises performed regularly throughout the study.
Activities include animal walks (bear walk, bunny hops, frog jumps) to enhance core and limb strength; bridging exercises to strengthen glutes and hamstrings; sit-to-stand training to improve lower limb strength and functional movement; tandem walking to challenge balance; standing on varied surfaces (foam/cushions) to improve proprioception; beam/line walking forward and backward for coordination and dynamic balance; and obstacle negotiation involving stepping over or around objects.
These exercises will be consistently practiced to enhance mobility and motor performance in children with cognitive impairment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Mobility
Time Frame: Baseline, 8 weeks
|
Functional mobility will be assessed using the Timed Up and Go (TUG) test as the primary outcome measure.
It evaluates a child's ability to stand up from a chair, walk a short distance, turn, return, and sit down, measuring mobility, balance, and functional movement efficiency.
|
Baseline, 8 weeks
|
|
Gross motor Skills
Time Frame: Baseline, 8 weeks
|
Gross motor skills will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) as a primary outcome measure.
It evaluates motor abilities including balance, coordination, strength, and agility through standardized tasks, providing a reliable measure of overall gross motor performance in children with cognitive impairment.
|
Baseline, 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maryam Shafique, MS-PT, Riphah International University Lahore
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/Maryam Shafique
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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