Vestibular Balance Therapy Intervention for Children

Not Applicable

Recruiting

• Conditions: Vestibular Disorder; Bilateral Vestibular Loss; Vestibulocochlear Nerve Diseases

• Registration Number: NCT05741515
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-02-23
• Study Start: 2023-03-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Sensory Organization Test at 4 and 8 weeks	Baseline (pre), 4 weeks (mid), 8 weeks (post)	A standardized test of static postural control
Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks	Baseline (pre), 4 weeks (mid), 8 weeks (post)	Difference in visual acuity with the head stationary versus moving
Change in Functional Gait Assessment at 4 and 8 weeks	Baseline (pre), 4 weeks (mid), 8 weeks (post)	A standardized test of dynamic balance

Secondary Outcome Measures

Name	Time	Method
Process Feasibility (Retention Rates)	through study period at 2 years	% of retention
Participant Experience Feasibility (Enjoyment)	through the study period at 2 years	Enjoyment level for each participant (ordinal scale of 0=no enjoyment to 10=extreme enjoyment)
Management Feasibility (training)	through year 1	time in minutes to train data collectors
Participant Experience Feasibility (Strategies)	through study period at 2 years	participant strategies that helped them with participation in the study (interview)
Process Feasibility (Refusal Rate Frequency)	through study completion at 2 years	Frequency of refusal to participate in the study
Process Feasibility (Completion Rates)	through study period at 2 years	% of participants who complete 80% of intervention sessions
Resource Feasibility (frequency)	through study period at 2 years	Frequency of communication with participants
Process Feasibility (Recruitment Rates)	through study completion at 2 years	% of individuals who follow through with enrollment procedures
Process Feasibility (Attrition Rates)	through study period at 2 years	% of attrition
Management Feasibility (data entry)	through year 1	time in minutes for data entry
Participant Experience Feasibility (Testing Difficulty)	baseline only - initial testing session	Participants will rate the level of difficulty of the initial testing session (0=not difficult to 10=extreme difficulty)
Participant Experience Feasibility (Intervention Difficulty)	once, at each participant's final testing session (8 weeks)	Participants will rate the level of difficulty of the overall intervention (0=not difficult to 10=extreme difficulty)
Resource Feasibility (time)	through study period at 2 years	Total time in minutes to communicate with participants

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States