Vestibular Balance Therapy Intervention for Children

Study Overview
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Brief Summary
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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
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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 6-12 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.

Official Title
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Feasibility of a Home-Based Vestibular Balance Therapy Intervention for Children With Vestibular Hypofunction

Conditions
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Vestibulocochlear Nerve Diseases, Vestibular Disorder, Bilateral Vestibular Loss

Intervention / Treatment
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* Other: Vestibular Balance Therapy
* Other: Sham Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed diagnosis of severe to profound SNHL age 6-12 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective single arm feasibility clinical trial. We will also enroll 3 children in a control intervention group, but these will be children without the condition, to determine the feasibility of the control intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VBP Intervention Group<br>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. | Other: Vestibular Balance Therapy<br>* see intervention arm description<br>* Other names: Vestibular Rehabilitation;|
| Sham Comparator: Sham Intervention<br>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. | Other: Sham Intervention<br>* see sham intervention arm description<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, vestibular rehabilitation, dynamic visual acuity, postural control, feasibility