Use of a Vibrotactile Feedback Belt in People With Chronic Disabling Unilateral Vestibular Hypofunction: a Single-case Experiment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Mobility and Balance Score (MBS)
研究概览
简要总结
The goal of this clinical trial is to study the impact of a continuous vibrotactile feedback belt on balance, (fear of) falling, fatigue and overall functioning in participants with chronic disabling unilateral vestibular hypofunction.
The main questions it aims to answer are: • does wearing a vibrotactile feedback belt during waking hours for a week improve sense of balance and mobility, fear of falling, fatigue and overall functioning • does wearing a vibrotactile feedback belt influence static and dynamic balance and gait performance during balance and gait testing.
Participants will goes through different phases in an randomized order; a baseline phase, a sham phase (i.e., wearing the BalanceBelt while it is switched off) and an intervention phase (i.e., wearing the BalanceBelt while it is switched on).
It is expected that, just as with patients with bilateral loss of the balance organ, patients with a unilateral loss will also benefit from the BalanceBelt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data-analyst and test-observer are masked
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with severe unilateral vestibular dysfunction (i.e., a gain below 0.6 of the affected side and a gain between 0.8 and 1.1 of the contralateral side measured by the video-Head Impulse Test (vHIIT)).
- •Duration of dizziness complaints >3 months (i.e. chronic dizziness).
- •Self-reported imbalance with a fear of falling and/or actual falls.
- •Is able to walk (with or without a walking aid).
- •Self-reported overall Mobility and Balance Score (MBS) of 3-5 points
- •Motivated to try the BalanceBelt.
- •Provides written informed consent.
排除标准
- •Age < 18 years
- •Presence of neurological, psychiatric or orthopaedic disorders, Persistent postural-perceptual dizziness (PPPD), reduced proprioceptive sensitivity or impaired vision which influences the postural stability.
- •Not able to understand instructions and questionnaires in Dutch
- •Not able/willing to visit Gelre Hospital Apeldoorn for necessary visits.
- •Wheelchair bound at home
研究组 & 干预措施
Baseline
Wearing no Balancebelt.
Sham condition
Wearing the BalanceBelt while it is switched off
干预措施: BalanceBelt (Device)
Intervention
Wearing the BalanceBelt while it is switched on
干预措施: BalanceBelt (Device)
结局指标
主要结局
Mobility and Balance Score (MBS)
时间窗: Daily for 7 weeks
The MBS is a rating given by the patient on a scale ranging from 0 to 10, as a subjective grading of his or her overall mobility and balance in daily life. Where a higher score means a better score.
次要结局
- falls(Daily for 7 weeks)
- Dynamic Gait Index (DGI)(At the baseline and at the end of the study (8 weeks))
- Timed up and Go test (TUG)(At baseline and at the end of the study (8 weeks))
- Fear of falling(Daily for 7 weeks)
- fatigue(Daily for 7 weeks)
- structured interview on compliance on wearing the Balancebelt(R)(Daily for 7 weeks)
- Questionnaire: Dizziness handicap inventory (DHI)(At baseline and at the end of the study (8 weeks))
- General functioning(Daily for 7 weeks)
- physical activity_NRS(Daily for 7 weeks)
- physical activity_steps(Daily for 7 weeks)
- Questionnaire: vestibular activity avoiding instrument (VAAI)(At baseline and at the end of the study (8 weeks))
- modified Clinical Test of Sensory Interaction on Balance (mCTSIB)(At baseline and at the end of the study (8 weeks))
研究者
Hanna van Eijsden
clinical investigator
Gelre Hospitals