An interventional study of Vestibular Stimulation Exercises and Foot Intrinsic Muscle Exercises in Down Syndrome, Balance Impairment and Functional Mobility, sponsored by Shalamar Institute of Health Sciences. Not yet recruiting. Open to participants aged 4 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Shalamar Institute of Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
This study's planned enrollment of 48 is above the median of 37 across 286 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →Shalamar Institute of Health Sciences is the lead sponsor of 17 studies on the registry; 13 are open to participants now.
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Participants in this group will receive vestibular stimulation exercises 3 times per week for 8 weeks, for a total of 24 sessions. Each session will last 20 minutes, with a 5-minute rest interval. The intervention will include spinning while sitting on a Swiss ball, sliding while lying on a large roller pillow, and vertical bouncing while sitting on a roller. Balance and functional mobility will be assessed at baseline (Week 0), immediately after the intervention (Week 8), and at follow-up (Week 12). Balance will be measured using the Pediatric Balance Scale (PBS), and functional mobility will be assessed using the Timed Up and Go (TUG) test.
Other: Vestibular Stimulation Exercises
Participants in this group will receive foot intrinsic muscle exercises 3 times per week for 8 weeks, for a total of 24 sessions. Each session will last 20 minutes, with a 5-minute rest interval. The intervention will include toe curls, marble pickups, short foot exercises, ball rolling, heel raises, step-ups, and football kicking. Seated calf stretching will be performed as a warm-up and cool-down before and after strengthening exercises. Balance and functional mobility will be assessed at baseline (Week 0), immediately after the intervention (Week 8), and at follow-up (Week 12). Balance will be measured using the Pediatric Balance Scale (PBS), and functional mobility will be assessed using the Timed Up and Go (TUG) test.
Other: Foot Intrinsic Muscle 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.
Also known as: VSE
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.
Also known as: FIME
Change in Balance Measured by the Pediatric Balance Scale (PBS)
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.
Time frame: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
Change in Functional Mobility Measured by the Timed Up and Go (TUG) Test
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.
Time frame: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be made available to other researchers.
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 163 non-industry interventional studies with no phase under Down Syndrome, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 35. This study's planned 5 months is below that.
Counting every sponsor, half of 165 studies reached it within 11 months; a quarter within 3 and three quarters within 35.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Shalamar Institute of Health Sciences