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Vestibular Balance Therapy for Vestibular Disorders (VBT-C Trial)

N/A

Recruiting

Led By Jennifer B Christy, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of severe to profound SNHL

Age 6-12 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study period at 2 years

Awards & highlights

VBT-C Trial 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.

Who is the study for?

This trial is for children aged 6-12 with severe to profound sensorineural hearing loss (SNHL) who can commit, along with their caregiver, to an 8-week home-based vestibular balance therapy program. They must have had a vision test within the last year or be willing to undergo one. Children with other neurological conditions, poor reading or picture identification skills, current vestibular therapy, or uncorrected vision issues are not eligible.Check my eligibility

What is being tested?

The study tests a home-based vestibular balance therapy designed for children with vestibular hypofunction. Over eight weeks, participants will perform exercises five times per week and have weekly check-ins with a physical therapist. The aim is to assess the feasibility of this program and its preliminary impact on function before planning a larger trial.See study design

What are the potential side effects?

Since this intervention involves physical exercises at home under supervision rather than medication, side effects may include dizziness or imbalance during initial sessions but should improve as therapy progresses.

VBT-C Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with severe to profound hearing loss.

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I am between 6 and 12 years old.

VBT-C Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the study period at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the study period at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the study period at 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Management Feasibility (data entry)

Management Feasibility (training)

Participant Experience Feasibility (Enjoyment)

+10 more

VBT-C Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VBP Intervention GroupExperimental Treatment1 Intervention

Children coded as abnormal on functional tests (FT) (n=12) will participate in an 8-week 5X/week home-based VBT program. At the initial visit (T0), the PI will instruct the participants (caregiver and child) in the program and provide all materials. The exercises will be led by the caregiver, with weekly in person checks by the PI to progress and provide coaching. The child/caregiver will complete a daily log to report activities and level of enjoyment. VBT will be done 5 days/week and will include 4 key categories of exercises, each lasting 5 minutes (20 minutes total of exercise per day). The 4 categories, explained below, include: 1) Times 1 (X1) Viewing, 2) Gaze Shifting, 3) Static Balance, 4) Dynamic Balance. The proposed VBT home program will include 10 minutes of gaze stabilization exercises, and 10 minutes of balance training.

Group II: Sham InterventionPlacebo Group1 Intervention

Sham Intervention (not to be compared to intervention - for feasibility only): Aim 1 is to establish the feasibility of a control intervention to be used in future studies. Therefore, 3 participants who score above the set criterion for the Functional Tests (FT) (i.e., they do not need VBT) will participate in an 8-week sham intervention. At T0, the PI will instruct the participants to do the sham intervention, led by the caregiver with weekly checks to control for attention bias. The sham intervention will be done for 20 minutes per day and will consist of 10 minutes of focused reading a book of the child's choice and 10 minutes of active play. The child and caregiver will complete a daily activity log documenting the activity and level of enjoyment.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,467 Total Patients Enrolled

Foundation for Physical Therapy ResearchUNKNOWN

1 Previous Clinical Trials

1,441 Total Patients Enrolled

Jennifer B Christy, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Vestibular Balance Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05741515 — N/A

Vestibulocochlear Nerve Disease Research Study Groups: VBP Intervention Group, Sham Intervention

Vestibulocochlear Nerve Disease Clinical Trial 2023: Vestibular Balance Therapy Highlights & Side Effects. Trial Name: NCT05741515 — N/A

Vestibular Balance Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05741515 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vestibular Balance Therapy Intervention for Children

Jennifer Braswell Christy 2023. "Vestibular Balance Therapy Intervention for Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05741515.

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