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Feasibility of a Home-Based Vestibular Balance Therapy Intervention for Children With Vestibular Hypofunction
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.
Approximately 60-75% of children with severe/profound sensorineural hearing loss (SNHL) also have vestibular hypofunction (VH), resulting in delayed gross motor development, poor postural control, and gaze instability. Although clinical practice guidelines provide recommendations for adults with VH, no statements exist for children due to a paucity of high- level studies. The long-term objective of this proposal is to assess feasibility of a home-based vestibular balance therapy (VBT) program for children so that a larger well-powered controlled study can be designed. The specific aims are to assess the intervention's feasibility (Aim 1), estimate its preliminary impact on functional outcomes (Aim 2), and assess participant engagement (secondary Aim). To accomplish this, we will use a prospective single arm feasibility design. We will enroll 15 children with SNHL, aged 4-17 years; 12 with confirmed VH for the VBT, and 3 with normal vestibular function to test the sham intervention. All children will be tested on the functional outcomes: computerized dynamic visual acuity, modified functional gait assessment, and sensory organization test at baseline, 4, and 8 weeks. A physical therapist (PT) will train children/caregivers in the 8-week structured VBT home program consisting of 4 categories of exercises (Times 1 viewing, gaze shifting, static and dynamic balance) done 5 times/week, 5 minutes/exercise. The PT will meet weekly with the child/caregiver in person to systematically progress the exercises. The children in the sham intervention (10 minutes of reading, 10 minutes of play) will also receive weekly meetings with the PT to control for attention bias. To assess Aim 1 (Feasibility) metrics will include process (e.g., recruitment rates), resources (e.g., communication needs), management (e.g., data collection/entry), experience (e.g., barriers). To assess Aim 2 (impact) we will analyze within group changes and effect sizes to design the larger study.
Age
4 - 17 years
Sex
ALL
Healthy Volunteers
No
UAB
Birmingham, Alabama, United States
Start Date
March 28, 2023
Primary Completion Date
August 18, 2025
Completion Date
August 18, 2025
Last Updated
January 14, 2026
21
ACTUAL participants
Vestibular Balance Therapy
OTHER
Sham Intervention
OTHER
Lead Sponsor
University of Alabama at Birmingham
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07200310