UnknownNot Applicable

VestibulOTherapy: Vestibular Impact on Learning

United States15 participantsStarted 2023-03-07

Plain-language summary

Research Question: Will daily engagement in activities tailored to the evidence-based vestibular research result in improved attention and learning outcomes for children ages 6-9 years of age after an 8-week classroom-based intervention?

Who can participate

Age range

6 Years – 10 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: * neurotypical development * between the ages of 6-10 years of age * performance challenges in school in the areas of math, spelling, organization, sequencing, attention, or engagement * demonstrate attributes of vestibular dysfunction per the Vestibular Profile * may have ADD or ADHD * May have challenges with speech articulation * good potential for learning and engaging in prescribed interventions Exclusion Criteria: * Neurodiverse development (with the exception of ADHD or ADD) * Absence of vestibular challenges * Absence of learning challenges. * unable to participate in interventions on a routine basis due to attendance or other limitations.

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 Academic Score reporting

Timeframe: Baseline data established at recruitment, followed by weekly data collection of scores from spelling and math for twelve weeks, and again once at three-months post intervention

Vestibular Attributes

Timeframe: up to twelve weeks

Time on Task / Attention

Timeframe: up to twelve weeks

Trial details

NCT IDNCT05793216

SponsorVestibulOTherapy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-05

View on ClinicalTrials.gov More Vestibular Disorder trials

Who can participate

Age range

6 Years – 10 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 Academic Score reporting

Timeframe: Baseline data established at recruitment, followed by weekly data collection of scores from spelling and math for twelve weeks, and again once at three-months post intervention

Vestibular Attributes

Timeframe: up to twelve weeks

Time on Task / Attention

Timeframe: up to twelve weeks