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

NCT07747376 | Active Not Recruiting

• 1 other identifier: NMRR ID-25-03771-REH (IIR)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Benign Paroxysmal Positional Vertigo (BPPV); Vestibular Hypofunction

Outcome Measures

Primary Outcomes (6)

• The Activities-specific Balance Confidence Scale

  From enrollment to the end of treatment at 20 weeks

• Dizziness Handicap Inventory

  From enrollment to the end of treatment at 20 weeks

• Dynamic Gait Index

  From enrollment to the end of treatment at 20 weeks

• Timed Up and Go

  From enrollment to the end of treatment at 20 weeks

• 5 Times Sit To Stand

  From enrollment to the end of treatment at 8 weeks

• EQ-5D-5L

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Other: Home-based therapy

Standard care

ACTIVE COMPARATOR

Other: Standard Care (in control arm)

Interventions

Home-based therapy OTHER

The intervention combines structured, progressive home-based exercises with a self-managed education resource. The exercises are based on vestibular rehabilitation principles and target movement-related dizziness, gaze stability, postural balance, gait, and functional mobility. Participants receive an illustrated booklet containing step-by-step exercise instructions, guidance on gradual progression and rest periods, and safety precautions. Exercise progression is adapted according to the participant's functional ability and symptom response. The education component addresses understanding of BPPV and vestibular hypofunction, safe exercise performance, symptom self-management, adherence, and when to seek professional advice. Participants are instructed to discontinue an exercise and obtain appropriate clinical advice if severe or worsening symptoms occur.

Intervention

Standard Care (in control arm) OTHER

Standard care consists of routine clinical management for BPPV with and without vestibular hypofunction provided at the study site. Treatment includes a canalith repositioning manoeuvre selected according to the affected semicircular canal and side, together with routine clinical advice and follow-up. Any additional management is determined by the treating clinician according to the participant's clinical needs and usual practice at the study site.

Standard care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Hizami bin Mustafa: lead

Study Sites (1)

Hospital Pulau Pinang

George Town, Pulau Pinang, 10990, Malaysia

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)