Development and Validation of a Home-based Exercise Programme Integrated With a Self-managed Education Programme in People With Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dizziness Handicap Inventory
研究概览
简要总结
The goal of this feasibility pilot randomised controlled trial is to determine whether a home-based exercise programme integrated with a self-managed education programme is feasible, acceptable, and safe for adults aged 60 years and older with benign paroxysmal positional vertigo (BPPV) with and without vestibular hypofunction. The study will also evaluate whether the trial procedures are suitable for a future definitive randomised controlled trial.
The main questions it aims to answer are:
Can participants follow the programme as planned? Can participants be retained throughout the 20-week study? Is the programme acceptable to participants? Do participants experience any adverse events? Do the clinical outcomes show preliminary changes that support further investigation?
Researchers will randomly assign participants to receive either the home-based exercise and self-managed education programme or standard care alone. Preliminary changes in dizziness, balance confidence, gait performance, fall risk, physical activity, and health-related quality of life will be explored. As this is a feasibility pilot study, it is not designed to provide definitive evidence of effectiveness.
Participants will:
Take part in the study for 20 weeks Follow their assigned intervention or standard care as instructed Complete assessments at baseline, week 10, and week 20 Report their adherence, experience with the programme, and any adverse events during the study
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
- None
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as benign paroxysmal positional vertigo by an otolaryngologist or Medical Doctor at the Ear, Nose, and Throat Clinic Hospital Pulau Pinang
- •Aged 60 years and older
- •Do not receive treatment from outside Hospital Pulau Pinang
排除标准
- •Severe neurological conditions, including stroke or peripheral neuropathy
- •Severe musculoskeletal disorders such as fractures, rheumatoid arthritis, or recent injuries that limit movement
- •• Clinically diagnosed hearing or visual impairments
研究组 & 干预措施
Standard care
干预措施: Standard Care (in control arm) (Other)
Intervention
干预措施: Home-based therapy (Other)
结局指标
主要结局
Dizziness Handicap Inventory
时间窗: From enrollment to the end of treatment at 20 weeks
Dynamic Gait Index
时间窗: From enrollment to the end of treatment at 20 weeks
The Activities-specific Balance Confidence Scale
时间窗: From enrollment to the end of treatment at 20 weeks
Timed Up and Go
时间窗: From enrollment to the end of treatment at 20 weeks
5 Times Sit To Stand
时间窗: From enrollment to the end of treatment at 8 weeks
EQ-5D-5L
时间窗: From enrollment to the end of treatment at 8 weeks
次要结局
未报告次要终点
研究者
Muhammad Hizami bin Mustafa
Physiotherapist
Universiti Teknologi Mara
