- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534085
Effects of a Structured Physical Activity Program on Balance and Functional Performance in Children With Down Syndrome (DS-YOGA)
Effects of a Structured Yoga-Based Physical Activity Program on Balance and Functional Performance in Children With Down Syndrome: A Pilot Intervention Study
Children with Down syndrome commonly exhibit hypotonia, impaired balance, and reduced functional mobility. This study aimed to evaluate the effects of a structured yoga-based physical activity program on balance and functional performance in children with Down syndrome.
Fifteen children aged 7-12 years participated in a 12-week intervention program consisting of adaptive yoga exercises, breathing techniques, and relaxation practices. Outcome measures included balance assessment using a sensor-based digital system and functional performance tests.
The findings are expected to provide evidence on the effectiveness of structured physical activity interventions in improving motor performance in children with Down syndrome.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study was designed as a single-group interventional pilot study to investigate the effects of a structured yoga-based physical activity program on balance and functional performance in children with Down syndrome.
Participants aged between 7 and 12 years were recruited from a special education center. The intervention lasted 12 weeks and included adaptive yoga postures, breathing exercises, and relaxation techniques tailored to the functional abilities of the participants.
Balance was assessed using a sensor-based digital balance system, and functional performance was evaluated using standardized clinical tests including the Timed Up and Go test, Five Times Sit to Stand test, Two-Minute Walk Test, and One-Leg Balance Test.
Assessments were conducted before and after the intervention. The study aimed to explore whether structured physical activity can improve postural control and functional mobility in children with Down syndrome.
This pilot study provides preliminary evidence to support the integration of structured physical activity programs into rehabilitation strategies for children with Down syndrome.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey (Türkiye)
- Ankara University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 7-18 years with a clinical diagnosis of Down syndrome
- Ability to follow simple verbal instructions
- Ability to stand independently with or without assistive devices
- Participation in a structured physical activity program
- Informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Severe orthopedic, neurological, or cardiovascular conditions affecting balance or mobility
- Uncontrolled epilepsy
- Severe visual or vestibular impairments affecting balance
- Recent lower limb surgery or injury (within the past 6 months)
- Inability to complete assessment procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga Intervention
Participants received a structured yoga-based physical activity program designed for children with Down syndrome.
The program focused on improving balance, postural control, and functional performance.
Sessions were conducted 3 times per week for 8 weeks, each lasting approximately 45-60 minutes.
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A structured yoga-based exercise program including balance, coordination, and postural control exercises tailored for children with Down syndrome.
The intervention aimed to enhance motor performance and functional abilities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static Balance Performance
Time Frame: Baseline and 8 weeks intervention
|
Static balance was assessed using a sensor-based balance system (BOBO Pro 2).
Measurements included stability and postural sway parameters recorded during quiet standing in children with Down syndrome.
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Baseline and 8 weeks intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Balance Performance
Time Frame: Baseline and 8 weeks intervention
|
Dynamic balance was evaluated using functional balance tasks with a sensor-based system (BOBO Pro 2), assessing movement control and postural stability during dynamic activities in children with Down syndrome.
|
Baseline and 8 weeks intervention
|
|
Functional Performance (Timed Up and Go Test and Five Times Sit-to-Stand Test)
Time Frame: Baseline and 8 weeks intervention
|
Functional performance was assessed using standardized functional tests including the Timed Up and Go (TUG) test and the Five Times Sit-to-Stand (5xSTS) test.
The TUG test evaluates functional mobility, balance, and walking ability, and is recorded as the time in seconds required to stand up from a chair, walk 3 meters, turn, walk back, and sit down.
The 5xSTS test assesses lower limb strength and functional mobility and is recorded as the time in seconds required to complete five consecutive sit-to-stand repetitions.
All assessments were conducted in children with Down syndrome.
|
Baseline and 8 weeks intervention
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Genetic Diseases, Inborn
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Abnormalities, Multiple
- Intellectual Disability
- Chromosome Disorders
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Behavior
- Down Syndrome
- Motor Activity
Other Study ID Numbers
- 2025/373-ANKU-ETIK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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