CompletedNot Applicable

Vestibular Balance Therapy Intervention for Children

United States21 participantsStarted 2023-03-28

Plain-language summary

The goal of this within groups clinical trial is to determine the feasibility of a home-based vestibular balance therapy program for children with vestibular hypofunction. The main questions to be answered are: 1) what is the intervention's feasibility and 2) what is the intervention's preliminary impact on function? Participants will receive a comprehensive battery of vestibular function and balance tests, then an 8-week home-based intervention to be done 5 times/week with weekly checks from the physical therapist. Data will be used to design a larger clinical trial with a comparison group.

Who can participate

Age range

4 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * confirmed diagnosis of severe to profound SNHL * age 4-17 years * caregiver/child verbal willingness to commit to the home vestibular balance therapy or sham intervention * vision screening/testing within 1 year or willingness to get a vision test. Exclusion Criteria: * neurologic condition other than SNHL * inability to read at a kindergarten level or identify pictures * currently receiving vestibular therapy * uncorrected vision problems unrelated to a vestibular deficit

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks

Timeframe: Baseline (pre), 4 weeks (mid), 8 weeks (post)

Change in Functional Gait Assessment at 4 and 8 weeks

Timeframe: Baseline (pre), 4 weeks (mid), 8 weeks (post)

Change in Sensory Organization Test at 4 and 8 weeks

Timeframe: Baseline (pre), 4 weeks (mid), 8 weeks (post)

Trial details

NCT IDNCT05741515

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-18

View on ClinicalTrials.gov More Vestibulocochlear Nerve Diseases trials

Plain-language summary

Who can participate

Age range

4 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks

Timeframe: Baseline (pre), 4 weeks (mid), 8 weeks (post)

Change in Functional Gait Assessment at 4 and 8 weeks

Timeframe: Baseline (pre), 4 weeks (mid), 8 weeks (post)

Change in Sensory Organization Test at 4 and 8 weeks

Timeframe: Baseline (pre), 4 weeks (mid), 8 weeks (post)