VBP Intervention Group for Bilateral Vestibulopathy

UAB, Birmingham, AL
Bilateral Vestibulopathy+2 More ConditionsVestibular Balance Therapy - Other
Eligibility
6 - 12
All Sexes

Study Summary

This trial tests the feasability of a home-based balance therapy program for kids with vestibular hypofunction. Tests, an 8-week home-based intv. & weekly checks from PTs will be used to design a larger trial w/a comparison group.

Eligible Conditions
  • Vestibular Disorder
  • Bilateral Vestibulopathy
  • Vestibulocochlear Nerve Disease

Treatment Effectiveness

Study Objectives

3 Primary · 13 Secondary · Reporting Duration: through study period at 2 years

Week 8
Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks
Change in Functional Gait Assessment at 4 and 8 weeks
Change in Sensory Organization Test at 4 and 8 weeks
baseline only - initial testing session
Participant Experience Feasibility (Testing Difficulty)
Week 8
Participant Experience Feasibility (Intervention Difficulty)
Year 2
Process Feasibility (Recruitment Rates)
Process Feasibility (Refusal Rate Frequency)
Year 2
Participant Experience Feasibility (Strategies)
Process Feasibility (Attrition Rates)
Process Feasibility (Completion Rates)
Process Feasibility (Retention Rates)
Resource Feasibility (frequency)
Resource Feasibility (time)
Year 2
Participant Experience Feasibility (Enjoyment)
through year 1
Management Feasibility (data entry)
Management Feasibility (training)

Trial Safety

Trial Design

2 Treatment Groups

VBP Intervention Group
1 of 2
Sham Intervention
1 of 2

Experimental Treatment

Non-Treatment Group

15 Total Participants · 2 Treatment Groups

Primary Treatment: VBP Intervention Group · Has Placebo Group · N/A

VBP Intervention Group
Other
Experimental Group · 1 Intervention: Vestibular Balance Therapy · Intervention Types: Other
Sham Intervention
Other
ShamComparator Group · 1 Intervention: Sham Intervention · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study period at 2 years

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,475 Previous Clinical Trials
2,246,212 Total Patients Enrolled
Foundation for Physical Therapy ResearchUNKNOWN
Jennifer B Christy, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Eligibility Criteria

Age 6 - 12 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between 6 and 12 years old.
You and your caregiver are willing to commit to either the home vestibular balance therapy or a fake version of it.
You have had an eye exam in the past year or are willing to have one.

Frequently Asked Questions

Is this research project accessible to individuals under 35 years of age?

"Candidates for the trial should be between the ages of 6 and 12 years old." - Anonymous Online Contributor

Unverified Answer

Are any new participants being accepted for this clinical trial?

"As per the clinicaltrials.gov website, this trial is not in need of new participants at this time; having been first posted on March 1st 2023 and last updated on February 22nd 2023. However, there are currently 159 other medical trials actively looking for enrollees." - Anonymous Online Contributor

Unverified Answer

What goals does this clinical trial seek to accomplish?

"Evaluating over a pre-test, midpoint, and post-test period of 4 weeks and 8 weeks respectively, the main outcome measure for this trial is Change in Functional Gait Assessment at both time points. Secondary metrics include Refusal Rate Frequency (Frequency of refusal to participate), Attrition Rates (% of attrition) ,and Retention Rates (% retention)." - Anonymous Online Contributor

Unverified Answer

Who can be accepted as participants in this trial?

"This clinical trial is presently enrolling 15 children aged 6-12 years old with vestibulocochlear nerve affliction. In order to be accepted, participants must have a confirmed diagnosis of severe to profound SNHL, an up-to-date vision screening/testing (or the willingness to get one), and their parent or guardian's verbal commitment towards either home vestibular balance therapy or sham intervention." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.