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NCT Number: NCT07778654

Vestibular Stimulation Versus Foot Intrinsic Muscle Exercises in Children With Down Syndrome

This study will compare the effects of vestibular stimulation exercises and foot intrinsic muscle exercises on balance and functional mobility in children with Down syndrome aged 4-15 years. Children with Down syndrome commonly experience balance and mobility difficulties due to hypotonia, ligamentous laxity, and impaired postural control. The study will determine which of the two exercise approaches is more effective in improving balance and functional mobility, using the Pediatric Balance Scale (PBS) and Timed Up and Go (TUG) test. The findings may help physiotherapists select appropriate rehabilitation strategies to improve functional independence in children with Down syndrome.

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Key information

About this study

Down syndrome (DS) is a genetic disorder commonly associated with hypotonia, ligamentous laxity, impaired postural control, motor incoordination, and balance difficulties. These impairments can negatively affect functional mobility and participation in activities of daily living. Balance is one of the major functional domains affected in children and adolescents with Down syndrome. Postural instability may result in increased displacement of the center of mass during gait and center of pressure during standing, which can further affect gait performance, transfers, and other functional activities.

Pes planus (flat foot) is also frequently observed in individuals with Down syndrome and may contribute to impaired balance, physical activity, and quality of life. Vestibular stimulation exercises (VSE) provide repetitive sensory information regarding body position, movement, and orientation in space and may improve postural control and balance. Similarly, foot intrinsic muscle exercises (FIMEs) aim to strengthen the muscles responsible for foot stability and may improve foot function, postural control, gait, and functional mobility.

Previous studies have reported beneficial effects of vestibular stimulation and foot intrinsic muscle exercises when used independently in individuals with Down syndrome or balance-related impairments. However, there is limited research directly comparing these two approaches in children with Down syndrome. Therefore, this study will compare the effects of vestibular stimulation exercises and foot intrinsic muscle exercises on balance and functional mobility in children aged 4-15 years with Down syndrome.

Balance will be assessed using the Pediatric Balance Scale (PBS), while functional mobility will be evaluated using the Timed Up and Go (TUG) test. The study aims to determine which intervention provides greater improvement in balance and functional mobility. The findings may help physiotherapists and rehabilitation professionals select an appropriate exercise approach for children with Down syndrome and contribute to the development of more effective pediatric rehabilitation strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Children with Down syndrome with age range (4-15 years) both male and female children included [12]. • Children who are able to stand and walk/ambulate independently and follow verbal instructions and commands and comply with intervention protocol [13]. • No visual and hearing impairment • Parent/guardian willing to provide consent for participant

Exclusion criteria

  • Associated congenital heart disease • Hearing impairment, eye problems such as cataract or other visual impairment • Dementia and cognitive decline. • Lower limb trauma or surgical intervention within the previous 6 months affecting comprehension or ability to perform balance/mobility activities [13]

Treatment and study plan

Vestibular Stimulation Exercises

Other

A structured vestibular stimulation exercise program designed to improve postural control, balance, and functional mobility in children with Down syndrome. The program includes sensory-motor activities involving controlled rotational, linear, and vertical movements.

Other names: VSE

Foot Intrinsic Muscle Exercises

Other

A structured foot muscle strengthening program designed to improve foot stability, postural control, balance, and functional mobility in children with Down syndrome. The program targets the intrinsic muscles of the foot through functional strengthening activities.

Other names: FIME

Primary outcomes

  1. Change in Balance Measured by the Pediatric Balance Scale (PBS)

    Time frame: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)

    Balance will be assessed using the Pediatric Balance Scale (PBS), a 14-item clinical measure of functional balance in children. The total score ranges from 0 to 56, with higher scores indicating better balance. The change in PBS score from baseline will be evaluated to determine the effect of the interventions on balance.

Secondary outcomes

  1. Change in Functional Mobility Measured by the Timed Up and Go (TUG) Test

    Time frame: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)

    Functional mobility will be assessed using the Timed Up and Go (TUG) test. The TUG measures the time, in seconds, required for a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. A shorter completion time indicates better functional mobility. The change in TUG completion time from baseline will be evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

arooj hanif, DPT

CONTACT

[email protected]

03206550216

laiba shad, DPT

CONTACT

[email protected]

03066493073

Sponsors and collaborators

Lead sponsor

Shalamar Institute of Health Sciences

Other

Registry information

Official study title

Effects of Vestibular Stimulation VS Foot Intrinsic Muscles Exercises on Balance and Functional Mobility in Children With Down's Syndrome

Acronym: VESTIB-FIME

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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