NCT06943144

Brief Summary

This study aims to compare the effectiveness of embodied learning and dual-task training in improving coordination and cognitive function in children with Down syndrome. It involves 22 participants aged 7-12, excluding those with other neurological or orthopedic conditions. Participants will be referred from civil hospital Sialkot. Assessments include the Pediatric Balance Scale, Timed Up and Go Test, and other balance measures. Interventions include embodied learning (e.g., yoga, storytelling, sensory play) and dual-task activities (e.g., walking while solving puzzles). The goal is to enhance daily functioning and quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2025

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

April 17, 2025

Last Update Submit

July 3, 2025

Conditions

Keywords

Down SyndromeMotor CoordinationMotor SkillsPsychomotor PerformanceCognitive Dysfunction

Outcome Measures

Primary Outcomes (5)

  • Pediatric Balance Scale(PBS)

    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.

    8 weeks

  • Timed Up and Go (TUG)

    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.

    8 weeks

  • Single Leg Stance (SLS)

    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.

    8 weeks

  • 30-Second Sit to Stand Test (30CST)

    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.

    8 weeks

  • Four Stage Balance Test

    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.

    8 weeks

Study Arms (2)

Dual task Training

ACTIVE COMPARATOR

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.

Other: Dual task Training

Embodied Learning

ACTIVE COMPARATOR

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.

Other: Embodied Learning

Interventions

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.

Dual task Training

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.

Embodied Learning

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed with Down Syndrome
  • Age 7 to 12 years
  • Ability to follow instructions effectively

You may not qualify if:

  • Neurological conditions (cerebral palsy or epilepsy)
  • Orthopedic conditions (Foot Abnormalities,s Hip Dysplasia)
  • Significant sensory impairments (e.g., severe hearing or vision impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imran Amjad

Lahore, Punjab Province, 5400, Pakistan

Location

Related Publications (1)

  • Izquierdo-Gomez R, Esteban-Cornejo I, Cabanas-Sanchez V, Marcos A, Gomez-Martinez S, Castro-Pinero J, Veiga OL; UP&DOWN Study Group. Are obesity and physical fitness associated with cardiovascular disease risk in adolescents with Down syndrome? The longitudinal UP&DOWN study. J Intellect Dev Disabil. 2023 Sep;48(3):247-259. doi: 10.3109/13668250.2023.2188876. Epub 2023 Mar 30.

    PMID: 39815918BACKGROUND

MeSH Terms

Conditions

Down SyndromeCognitive Dysfunction

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Maria Mahmood, MS-PPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

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
Model Details: Participants will be referred by Civil Hospital Sialkot and screened for eligibility. Guardians of eligible participants will provide informed consent prior to enrollment. A total of 22 participants will be randomly assigned via computer-generated randomization into two groups: Group A (Dual Task Learning) and Group B (Embodied Learning), with 11 participants in each. This single-blinded study will ensure the outcome assessor remains unaware of group assignments. Group A will engage in dual-task training-such as walking while solving math problems or identifying objects-twice a week for 30 minutes to improve cognitive-motor coordination. Group B will participate in embodied learning activities-such as yoga, gesture-based learning, storytelling, art, and sensory play-twice a week for 45-60 minutes to promote cognitive development through full-body engagement.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 24, 2025

Study Start

April 16, 2025

Primary Completion

June 10, 2025

Study Completion

June 16, 2025

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations