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临床试验/NCT07747376
NCT07747376进行中(未招募)不适用

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

Muhammad Hizami bin Mustafa1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年5月4日最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: Standard Care (in control arm) (Other)

Intervention

Experimental

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

发起方
Muhammad Hizami bin Mustafa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Muhammad Hizami bin Mustafa

Physiotherapist

Universiti Teknologi Mara

研究点 (1)

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