- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06943144
Comparative Effects of Dual Task Training and Embodied Learning on Dual Task Performance in Children With Down Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Down Syndrome is Caused by an extra copy of chromosome 21, characterized by impaired motor skills, especially difficulties with coordination, and cognitive impairment. Improving these abilities is essential to raising the affected children's quality of life and everyday functioning. Dual task learning and embodied learning stand out among other interventions as effective strategies. While embodied learning uses physical motions to support cognitive growth, dual task learning mixes motor and cognitive tasks concurrently, testing the brain's capacity for multitasking. The purpose of this study is to compare how well embodied learning and dual task training work to improve dual task performance in kids with Down syndrome.
This study contains 22 participants age 7 to12 years and excludes participants with other neurological or orthopedic disorders, is focused on individuals who match the inclusion criteria Children that are being able to follow instructions. The Participants will be Referred by Civil hospital Sialkot. To test changes in motor coordination and balance, assessment tools such as the Pediatric Balance Scale (PBS), timed Up and Go Test, Single Leg Stance Test, Four Stage Balance Test, and 30-second Sit to Stand Test will be used. In order to evaluate cognitive engagement and the development of motor skills, dual task training setups (such as walking while labelling objects or balancing while solving puzzles) as well as embodied learning activities (such as Gesture-Based Learning, Physical Storytelling, Yoga, and Sensory Play Art) will be used. The purpose of this research is to offer useful knowledge about the effectiveness and practicality of various interventions in improving the everyday functioning and quality of life of children with Down syndrome.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 5400
- Imran Amjad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children diagnosed with Down Syndrome
- Age 7 to 12 years
- Ability to follow instructions effectively
Exclusion Criteria:
- Neurological conditions (cerebral palsy or epilepsy)
- Orthopedic conditions (Foot Abnormalities,s Hip Dysplasia)
- Significant sensory impairments (e.g., severe hearing or vision impairments.
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 |
|---|---|
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Active Comparator: Dual task Training
dual-task training, participants walk while doing cognitive tasks like counting or object identification to improve coordination and focus.
Sessions are 30 minutes, twice weekly, with varying task difficulty and breaks for rest.
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In dual-task training, participants walk while performing cognitive tasks such as object identification, counting backward, or solving math problems.
These exercises aim to improve coordination, attentional control, and dual-task performance by simultaneously engaging cognitive and motor functions.
Training sessions are held twice a week, each lasting 30 minutes with breaks for rest and reflection.
Tasks vary in complexity to progressively challenge participants and enhance both cognitive processing and gait stability.
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Active Comparator: Embodied Learning
Participants attend twice-weekly 45-60 minute sessions using movement-based activities like yoga, art, and storytelling to enhance learning.
Activities are tailored to individual needs.
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Participants in the embodied learning group engage in activities such as yoga, painting, sensory play, physical storytelling, gesture-based learning, and creative storytelling.
These exercises use full-body movement to support learning and cognitive development.
Examples include using gestures to reinforce concepts, acting out stories to blend movement with narrative, and engaging in yoga for focus and calmness.
Art and sensory activities further promote creativity and tactile exploration.
Sessions are held twice a week, lasting 45 to 60 minutes, and are tailored to individual needs and progress.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pediatric Balance Scale(PBS)
Time Frame: 8 weeks
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The Pediatric Balance Scale (PBS) is a reliable and valid tool used to assess functional balance in school-aged children with mild to moderate motor impairments.
It includes 14 items scored from 0 to 4, with a maximum score of 56.
The PBS has shown excellent test-retest and interrater reliability and demonstrates strong correlations with functional outcomes such as self-care and mobility.
It is also supported by its alignment with other motor assessments, making it an effective measure for evaluating and tracking balance skills in children with motor challenges.
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8 weeks
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Timed Up and Go (TUG)
Time Frame: 8 weeks
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The Timed Up and Go (TUG) test is a reliable and widely used tool for assessing mobility and fall risk across various populations.
It demonstrates strong inter-rater and test-retest reliability, particularly in individuals with joint conditions.
The test correlates well with key functional measures such as gait speed, postural control, and step length, and effectively predicts fall risk, making it a valuable tool for evaluating functional mobility.
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8 weeks
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Single Leg Stance (SLS)
Time Frame: 8 weeks
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The Single Leg Stance (SLS) Test evaluates static balance by measuring how long an individual can stand on one leg with eyes open and hands on hips.
It is useful for detecting balance impairments, particularly in conditions like Total Knee Arthroplasty and Hip Osteoarthritis, and can indicate fall risk in older adults.
The test demonstrates good reliability in these populations, though normative data remains limited.
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8 weeks
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30-Second Sit to Stand Test (30CST)
Time Frame: 8 weeks
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The 30-Second Sit to Stand Test (30CST) is a reliable and valid tool for assessing lower limb strength and endurance in diverse populations.
It shows excellent test-retest, inter-rater, and intra-rater reliability, with strong correlations to other measures of lower extremity function, such as leg press performance.
Widely used in clinical and research settings, the 30CST offers a consistent and objective measure of physical performance and functional capacity.
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8 weeks
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Four Stage Balance Test
Time Frame: 8 weeks
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The Four Stage Balance Test is reliable (interclass correlation = 0.66) over a 3-4-month interval with 187 subjects, indicating stable results.
It demonstrates robust validity through strong correlations with established balance measures, making it an effective tool for identifying fall risk in older adults and guiding targeted interventions.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Mahmood, MS-PPT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/0735
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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