Feasibility of a Home-Based Vestibular Balance Therapy Intervention for Children With Vestibular Hypofunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Sensory Organization Test at 4 and 8 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinicians doing the functional outcome measures (FGA, DVA, SOT) will not know the result of the vestibular function tests.
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
VBP Intervention Group
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.
干预措施: Vestibular Balance Therapy (Other)
Sham 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.
干预措施: Sham Intervention (Other)
结局指标
主要结局
Change in Sensory Organization Test at 4 and 8 weeks
时间窗: 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
时间窗: 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
时间窗: Baseline (pre), 4 weeks (mid), 8 weeks (post)
A standardized test of dynamic balance
次要结局
- Process Feasibility (Retention Rates)(through study period at 2 years)
- Participant Experience Feasibility (Enjoyment)(through the study period at 2 years)
- Management Feasibility (training)(through year 1)
- Participant Experience Feasibility (Strategies)(through study period at 2 years)
- Process Feasibility (Refusal Rate Frequency)(through study completion at 2 years)
- Process Feasibility (Completion Rates)(through study period at 2 years)
- Resource Feasibility (frequency)(through study period at 2 years)
- Process Feasibility (Recruitment Rates)(through study completion at 2 years)
- Process Feasibility (Attrition Rates)(through study period at 2 years)
- Management Feasibility (data entry)(through year 1)
- Participant Experience Feasibility (Testing Difficulty)(baseline only - initial testing session)
- Participant Experience Feasibility (Intervention Difficulty)(once, at each participant's final testing session (8 weeks))
- Resource Feasibility (time)(through study period at 2 years)
研究者
Jennifer Braswell Christy
Professor
University of Alabama at Birmingham