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Active, not recruitingNCT07747376Updated Aug 5, 2026

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

An interventional study of Home-based therapy and Standard Care (in control arm) in Benign Paroxysmal Positional Vertigo (BPPV) and Vestibular Hypofunction, sponsored by Muhammad Hizami bin Mustafa. Active, not recruiting at 1 site in Malaysia. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Muhammad Hizami bin Mustafa · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Benign Paroxysmal Positional Vertigo (BPPV)
  • Vestibular Hypofunction
03

In context

Benign Paroxysmal Positional Vertigo

73 studies on the registry are indexed under Benign Paroxysmal Positional Vertigo; 15 are open to participants now.

This study's enrollment of 30 is below the median of 75 across 59 interventional studies indexed under Benign Paroxysmal Positional Vertigo.

Browse Benign Paroxysmal Positional Vertigo studies →

Lead sponsor

This is the only study on the registry with Muhammad Hizami bin Mustafa as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Intervention

    Other: Home-based therapy

  • Active comparator
    Standard care

    Other: Standard Care (in control arm)

Interventions

  • OtherHome-based therapy

    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.

  • OtherStandard Care (in control arm)

    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.

06

What researchers measure

Primary outcomes

  1. The Activities-specific Balance Confidence Scale

    Time frame: From enrollment to the end of treatment at 20 weeks

  2. Dizziness Handicap Inventory

    Time frame: From enrollment to the end of treatment at 20 weeks

  3. Dynamic Gait Index

    Time frame: From enrollment to the end of treatment at 20 weeks

  4. Timed Up and Go

    Time frame: From enrollment to the end of treatment at 20 weeks

  5. 5 Times Sit To Stand

    Time frame: From enrollment to the end of treatment at 8 weeks

  6. EQ-5D-5L

    Time frame: From enrollment to the end of treatment at 8 weeks

07

Study locations

1 site
  • Hospital Pulau Pinang
    George Town, Pulau Pinang 10990, Malaysia
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because external sharing of participant-level data is not included in the ethics-approved data-management plan or participant consent process. Furthermore, the small, single-site sample and detailed clinical information may increase the risk of participant re-identification, even after de-identification. Study findings will be disseminated only in aggregated form through scientific publications and presentations.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07747376
Lead sponsor
Muhammad Hizami bin Mustafa
Responsible party
Muhammad Hizami bin Mustafa (Physiotherapist, Universiti Teknologi Mara) — Sponsor-investigator
First posted
Aug 5, 2026
Start date
May 4, 2026
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Aug 5, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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