Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07778654
Acronym
VESTIB-FIME
Enrollment
48
Registered
2026-08-21
Start date
2026-09-02
Completion date
2027-03-29
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance Impairment, Down Syndrome, Functional Mobility

Keywords

Down Syndrome, Vestibular Stimulation Exercises, Foot Intrinsic Muscle Exercises

Brief summary

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.

Detailed description

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.

Interventions

OTHERVestibular Stimulation Exercises

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.

OTHERFoot Intrinsic Muscle Exercises

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.

Sponsors

Shalamar Institute of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

No masking will be used. Participants, intervention providers, and outcome assessors will be aware of the group allocation

Intervention model description

This is a two-arm randomized controlled trial comparing vestibular stimulation exercises with foot intrinsic muscle exercises in children with Down syndrome aged 4-15 years. Participants will be randomly allocated to either the vestibular stimulation exercise group or the foot intrinsic muscle exercise group. Balance and functional mobility will be assessed before and after the intervention using the Pediatric Balance Scale (PBS) and Timed Up and Go (TUG) test.

Eligibility

Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
No

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 \[13\]

Design outcomes

Primary

MeasureTime frameDescription
Change in Balance Measured by the Pediatric Balance Scale (PBS)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

MeasureTime frameDescription
Change in Functional Mobility Measured by the Timed Up and Go (TUG) TestBaseline (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.

Contacts

CONTACTlaiba shad, DPT
laibashad27@gmail.com03066493073
CONTACTarooj hanif, DPT
aroojhanif6@gmail.com03206550216
STUDY_CHAIRDR SADAF TABASSAM, PHD

Shalamar Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026