App-supported Vestibular Rehabilitation (Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adherence measures
研究概览
简要总结
A randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to VR and treatment outcomes
详细描述
Vestibular Rehabilitation (VR) home exercises, prescribed by physiotherapists, are the main treatment for vestibular dysfunction. However, reports by clinicians indicate that patients do not fully comply with the treatment. Advances in technology and tele-rehabilitation have the potential to facilitate adherence to home exercise, if they are designed to overcome the barriers for practice. We plan to continue and expand our previous feasibility study with the vestibular phone app, in order to examine the effects of an app-assisted VR program on adherence and treatment outcomes. The patients in this study will be randomly assigned to the intervention (app-assisted vestibular rehabilitation) or the control group (standard vestibular rehabilitation, no app).
Tests and measurements for both groups will be done at three time points:
- Preliminary assessment session (Session 1)- An initial assessment test on the first visit;
- Secondary assessment session (Session 2)- After 5-6 weeks;
- Follow-up evaluation session (Session 3)- One month after the secondary assessment session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Individuals aged 18 and over
- •Diagnosis with any vestibular disorder that requires a vestibular rehabilitation exercise program
- •Physical and cognitive ability to perform vestibular physiotherapy
排除标准
- •A physical disability that does not allow for the performance of vestibular physiotherapy
- •A diagnosis of a central vestibular disorder caused by structural damage to the brain
- •Individuals who are not qualified to give informed consent
研究组 & 干预措施
App-assisted vestibular rehabilitation
The patients in this group will undergo standard vestibular rehabilitation treatment with the addition of a phone app that support the treatment program, e.g., providing reminders for exercise, documentation of exercise performance, communication with the therapist, etc.
干预措施: Vestibular rehabilitation phone application (Device)
Standard vestibular rehabilitation (no app)
The patients in this group will undergo standard vestibular rehabilitation treatment, without using the app.
结局指标
主要结局
Adherence measures
时间窗: At the end of Cycle 1 (each cycle is 4-6 weeks)
Quantitative data on adherence to home exercise will be extracted from users' phone application database (intervention group) or from records in a diary / logs (control group)
Timed up and go (TUG)
时间窗: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Assesses balance, walking ability and also used as a screening test for the risk of falls by assessing the function of the lower limbs. The individual is required to get up from sitting on a chair, walk 3 meter forward at a normal pace, turn around and return to a sitting position. The examiner times this sequence
次要结局
- Vestibular functions- physical examination(At the the beginning of Cycle 1 (each cycle is 4-6 weeks))
- Oculomotor functions- physical examination(At the the beginning of Cycle 1 (each cycle is 4-6 weeks))
- Activities-specific Balance Confidence Scale (ABC)(At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks))
- Dynamic Gait Index (DGI)(At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks))
- Video Head Impulse Test (vHIT)(At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks))
- Cognitive reserve index questionnaire (CRIQ)(By the end of Cycle 1 (each cycle is 4-6 weeks))
- 10-Meters Walk Test (10MWT)(At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks))
- 2-Minute Walk Test (2MWT)(At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks))
- Demographics and medical history intake(At the beginning of Cycle 1 (each cycle is 4-6 weeks))
- Dynamic Visual Acuity (DVA)(At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks))
- Suppression Head Impulse Test (SHIMP)(At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks))
- Visual Analogue Scale (VAS)(At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks))
- Dizziness Handicap Inventory (DHI)(At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks))
- Exercise difficulty levels and symptoms severity(At the end of Cycle 1 (each cycle is 4-6 weeks))
研究者
Yoav Gimon
Principal Investigator
University of Haifa