Effects of Vestibular Stimulation VS Foot Intrinsic Muscles Exercises on Balance and Functional Mobility in Children With Down's Syndrome
| Registry | NCT07778654, acronym VESTIB-FIME |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 48 (Estimated) |
| Sponsor | Shalamar Institute of Health Sciences (Other) |
| Conditions | Down Syndrome, Balance Impairment, Functional Mobility |
| Interventions | Vestibular Stimulation Exercises, Foot Intrinsic Muscle Exercises (Other) |
| Dates | start 2026-09-02 (estimated), primary completion 2027-02-28 (estimated), completion 2027-03-29 (estimated), first posted 2026-08-21, last updated 2026-08-21 |
Related Papers Related Patents Related Grants Related Experts
All trials for Down Syndrome All trials for Balance Impairment All trials of Vestibular Stimulation Exercises All trials of Foot Intrinsic Muscle Exercises
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Vestibular Stimulation Exercise Group | Experimental | Other: Vestibular Stimulation Exercises | 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. |
| Foot Intrinsic Muscle Exercises | Experimental | Other: Foot Intrinsic Muscle 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. |
Sex: All, ages: 4 Years to 15 Years
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 \[13\]