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

NCT07778654 | Not Yet Recruiting DMC

• 1 other identifier: SSAHS-2026-1126
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Down Syndrome; Balance Impairment; Functional Mobility

Keywords

Down Syndrome; Vestibular Stimulation Exercises; Foot Intrinsic Muscle Exercises

Outcome Measures

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.

  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

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

Study Arms (2)

Vestibular Stimulation Exercise Group

EXPERIMENTAL

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

Foot Intrinsic Muscle Exercises

EXPERIMENTAL

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

Interventions

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.

Also known as: VSE

Vestibular Stimulation Exercise Group

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.

Also known as: FIME

Foot Intrinsic Muscle Exercises

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 \[13\]

Sponsors & Collaborators

• Shalamar Institute of Health Sciences: lead

Related Publications (1)

• Bu Q, Qiang R, Cheng H, et al. Front Pediatr. 2022;10:882722. Khan F, Rahiyab M, Hussain I, et al. Int Health Rev. 2025;5(2):19-44. Giustino V, Messina G, Alesi M, et al. Hum Mov. 2021;22(1):66-71. Nahla IM, El-Sayed SE, Ragaa AE, et al. Afr Health Sci. 2022;22(1):377-383. Tuncer D, Erekdag A, Senaran H, et al. Eur J Pediatr. 2025;184:636. Halwsh SD, Algabbani MF, Alqabbani S, et al. Brain Sci. 2026;16(1):79. Siddiqui M, Farooqui S, Rizvi J, et al. Ann King Edward Med Univ. 2024;30(2):112-118. Ghouri EURK, Memon AG, Ali S, et al. J Liaquat Univ Med Health Sci. 2024;23(2):116-120. Adeeba N, Farooqui SI, Hasan ZM, et al. Dev Neurorehabil. 2024;27(5-6):145-153.

  RESULT

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• DR SADAF TABASSAM, PHD

  Shalamar Hospital

  STUDY CHAIR

Central Study Contacts

laiba shad, DPT

CONTACT

03066493073; laibashad27@gmail.com

arooj hanif, DPT

CONTACT

03206550216; aroojhanif6@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be used. Participants, intervention providers, and outcome assessors will be aware of the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 2, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 29, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share