Vestibular Stimulation Versus Foot Intrinsic Muscle Exercises in Children With Down Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-15
SponsorShalamar Institute of Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
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]
Trial design
Design model
Parallel
Treatments tested in this trial
Vestibular Stimulation Exercises
Other interventionA 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.
Foot Intrinsic Muscle Exercises
Other interventionA 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Vestibular Stimulation Exercise GroupExperimental treatment 1 intervention
Group B: Foot Intrinsic Muscle ExercisesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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