Down Syndrome (DS)DS-YOGANCT07534085
Effects of a Structured Physical Activity Program on Balance and Functional Performance in Children With Down Syndrome
A study testing Yoga Program in people with Down Syndrome (DS) and Balance Assessment, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Down Syndrome (DS), Balance Assessment, Physical Activities
- What is being tested?
- Yoga Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 5 Oct 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Yoga Program
- Keywords
- Down Syndrome, Yoga Therapy, Balance, Physical Performance, Rehabilitation
- Medical subject headings
- Down Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Intervention | Experimental | 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. Receives: Behavioral: Yoga Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance Performance
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.
Measured: Baseline and 8 weeks intervention
Secondary outcomes (2)
Dynamic Balance Performance
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.
Measured: Baseline and 8 weeks intervention
Functional Performance (Timed Up and Go Test and Five Times Sit-to-Stand Test)
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.
Measured: Baseline and 8 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jun 2025
- Primary completion3 Sep 2025
- Study completion5 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down Syndrome (DS)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants were assigned to a single group and received the same structured yoga-based physical activity intervention. Outcomes were assessed before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senem Guner, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534085
- Sponsor's protocol ID
- 2025/373-ANKU-ETIK
- Acronym
- DS-YOGA
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Structured Yoga-Based Physical Activity Program on Balance and Functional Performance in Children With Down Syndrome: A Pilot Intervention Study
- ClinicalTrials.gov ID
- NCT07534085
- Acronym / sponsor ID
- DS-YOGA / 2025/373-ANKU-ETIK
- Keywords
- Down Syndrome, Yoga Therapy, Balance, Physical Performance, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 5 Oct 2025 (actual)
- First posted
- 16 Apr 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants were assigned to a single group and received the same structured yoga-based physical activity intervention. Outcomes were assessed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Yoga Intervention | Experimental | Behavioral: Yoga ProgramParticipants 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Yoga ProgramA 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. | Behavioural | Yoga Intervention |
Primary outcome
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.
2 secondary outcomes
Dynamic Balance Performance
Time frame: 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
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 16 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Program in people with Down Syndrome (DS) and Balance Assessment, run by Ankara University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 16 Apr 2026. 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 Turkey (Türkiye). 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?
Static Balance Performance (time frame: Baseline and 8 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2026.