NCT07534085

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 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

June 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 9, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

Down SyndromeYoga TherapyBalancePhysical PerformanceRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 8 weeks intervention

Secondary Outcomes (2)

  • Dynamic Balance Performance

    Baseline and 8 weeks intervention

  • Functional Performance (Timed Up and Go Test and Five Times Sit-to-Stand Test)

    Baseline and 8 weeks intervention

Study Arms (1)

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.

Behavioral: Yoga Program

Interventions

Yoga ProgramBEHAVIORAL

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.

Yoga Intervention

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Down SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

June 1, 2025

Primary Completion

September 3, 2025

Study Completion

October 5, 2025

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations