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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.

Interventions

Vestibular Stimulation ExercisesOther

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 ExercisesOther

Eligibility Criteria

Age4 Years - 15 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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:

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 DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

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

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.

Sponsor Type

OTHER

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Vestibular Stimulation Exercise Group

Foot Intrinsic Muscle Exercises

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Vestibular Stimulation Exercise Group

Foot Intrinsic Muscle Exercises

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record