Down SyndromeVESTIB-FIMENCT07778654
Vestibular Stimulation Versus Foot Intrinsic Muscle Exercises in Children With Down Syndrome
A study testing Vestibular Stimulation Exercises and Foot Intrinsic Muscle Exercises in people with Down Syndrome and Balance Impairment, run by Shalamar Institute of Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Down Syndrome, Balance Impairment, Functional Mobility
- What is being tested?
- Vestibular Stimulation Exercises and Foot Intrinsic Muscle Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2026to 29 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Vestibular Stimulation VS Foot Intrinsic Muscles Exercises on Balance and Functional Mobility in Children With Down's Syndrome
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.
Read the detailed description
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.
- Conditions
- Down Syndrome, Balance Impairment, Functional Mobility
- Being tested
- Vestibular Stimulation Exercises, Foot Intrinsic Muscle Exercises
- Keywords
- Down Syndrome, Vestibular Stimulation Exercises, Foot Intrinsic Muscle Exercises
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Stimulation ExercisesOther
Also called VSE
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.
Foot Intrinsic Muscle ExercisesOther
Also called FIME
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Foot Intrinsic Muscle Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start2 Sep 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion29 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalamar Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DR SADAF TABASSAM, PHD, Study chair, Shalamar Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778654
- Sponsor's protocol ID
- SSAHS-2026-1126
- Acronym
- VESTIB-FIME
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vestibular Stimulation VS Foot Intrinsic Muscles Exercises on Balance and Functional Mobility in Children With Down's Syndrome
- ClinicalTrials.gov ID
- NCT07778654
- Acronym / sponsor ID
- VESTIB-FIME / SSAHS-2026-1126
- Conditions
- Down Syndrome, Balance Impairment, Functional Mobility
- Keywords
- Down Syndrome, Vestibular Stimulation Exercises, Foot Intrinsic Muscle Exercises
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shalamar Institute of Health SciencesUniversity, hospital or other
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 29 Mar 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vestibular Stimulation Exercise Group | Experimental | Other: Vestibular Stimulation ExercisesParticipants 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 ExercisesParticipants 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. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- • 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
Key exclusion criteria (1 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Stimulation ExercisesAlso: VSEA 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. | Other | Vestibular Stimulation Exercise Group |
| Foot Intrinsic Muscle ExercisesAlso: FIMEA 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. | Other | Foot Intrinsic Muscle Exercises |
Primary outcome
Change in Balance Measured by the Pediatric Balance Scale (PBS)
Time frame: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
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.
1 secondary outcome
Change in Functional Mobility Measured by the Timed Up and Go (TUG) Test
Time frame: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Results publicationBu 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.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DR SADAF TABASSAM, PHD study chair
Shalamar Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Stimulation Exercises and Foot Intrinsic Muscle Exercises in people with Down Syndrome and Balance Impairment, run by Shalamar Institute of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact laiba shad, DPT (03066493073, laibashad27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Balance Measured by the Pediatric Balance Scale (PBS) (time frame: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07778654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.