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Active Not Recruiting NCT07747376

Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme

Conditions: Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction

Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Muhammad Hizami bin Mustafa

Location: Hospital Pulau Pinang George Town Pulau Pinang

Summary

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

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07747376). StuddyBuddy aggregates publicly available trial information.