Down SyndromeNCT06943144
Comparative Effects of Dual Task Training and Embodied Learning on Dual Task Performance in Children With Down Syndrome
A study testing Dual task Training and Embodied Learning in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Dual task Training and Embodied Learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Apr 2025to 16 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with Down Syndrome
- Age 7 to 12 years
- Ability to follow instructions effectively
Who cannot join
- Neurological conditions (cerebral palsy or epilepsy)
- Orthopedic conditions (Foot Abnormalities,s Hip Dysplasia)
- Significant sensory impairments (e.g., severe hearing or vision impairments.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Dual task Training, Embodied Learning
- Keywords
- Down Syndrome, Motor Coordination, Motor Skills, Psychomotor Performance, Cognitive Dysfunction
- Medical subject headings
- Down Syndrome, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual task TrainingOther
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.
Embodied LearningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Embodied Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start16 Apr 2025
- Primary completion10 Jun 2025
- Study completion16 Jun 2025
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.
- 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
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Mahmood, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943144
- Sponsor's protocol ID
- REC/RCR&AHS/24/0735
- Status last verified
- Jul 2025
- First submitted
- 17 Apr 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39815918
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Dual Task Training and Embodied Learning on Dual Task Performance in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06943144
- Acronym / sponsor ID
- REC/RCR&AHS/24/0735
- Conditions
- Down Syndrome
- Keywords
- Down Syndrome, Motor Coordination, Motor Skills, Psychomotor Performance, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 24 Apr 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 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dual task Training | Active comparator | Other: Dual task Trainingdual-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. |
| Embodied Learning | Active comparator | Other: Embodied LearningParticipants 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children diagnosed with Down Syndrome
- Age 7 to 12 years
- Ability to follow instructions effectively
Key exclusion criteria (3 listed)
- Neurological conditions (cerebral palsy or epilepsy)
- Orthopedic conditions (Foot Abnormalities,s Hip Dysplasia)
- Significant sensory impairments (e.g., severe hearing or vision impairments.
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 |
|---|---|---|
| Dual task TrainingIn 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. | Other | Dual task Training |
| Embodied LearningParticipants 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. | Other | Embodied Learning |
Primary outcome
Pediatric Balance Scale(PBS)
Time frame: 8 weeks
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.
Timed Up and Go (TUG)
Time frame: 8 weeks
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.
Single Leg Stance (SLS)
Time frame: 8 weeks
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.
30-Second Sit to Stand Test (30CST)
Time frame: 8 weeks
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.
Four Stage Balance Test
Time frame: 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 39815918Izquierdo-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.
- 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. This study is not recruiting at the moment.
Maria Mahmood, 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 Dual task Training and Embodied Learning 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Balance Scale(PBS) (time frame: 8 weeks). The study lists 5 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 NCT06943144, 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 9 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.