ISRCTN ISRCTN17475939
DOI https://doi.org/10.1186/ISRCTN17475939
Sponsor Lund University
Funders Lunds Universitet, Lions Research Foundation Skåne
Submission date
21/10/2025
Registration date
16/02/2026
Last edited
16/02/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Balance impairment is one of the most important risk factors for falls. The prevalence of disability due to balance impairments increases with age, and older people face considerable problems with independence, participating in society and being physically active. The societal costs for healthcare and social services due to balance impairments and subsequent falls, and dependence on others, are high. Accordingly, more efficient interventions to prevent falls are called for. The purpose of this project is to test the feasibility of a future study on the effect of adding Virtual Reality (VR) to rehabilitation among older people with persistent balance impairment.

Who can participate?
Senior patients (aged 64 years and over) with a diagnosis of multisensory dizziness.

What does the study involve?
One group in the study will watch a VR movie, for balance challenging tasks, such as walking in a grocery store and also ordinary vestibular rehabilitation exercises and balance exercises in the form of a home-based training program. The control intervention will be a home-based training program only.

What are the possible benefits and risks of participating?
The benefit is that all participants receive a very thorough assessment of vestibular function and balance. Another benefit is that, if the Virtual Reality interventions are shown to have an effect, the participants have received effective treatment.

There is a small risk of falls during the Virtual Reality sessions. This is prevented by the physiotherapist standing close to the participants during sessions.

Where is the study run from?
Lund University, Sweden.

When is the study starting and how long is it expected to run for?
April 2025 to June 2026

Who is funding the study?
1. Lund University, Sweden.
2. Lions Research Foundation Skåne, Sweden.

Who is the main contact?
Prof Eva Ekvall Hansson, eva.ekvall_hansson@med.lu.se

Contact information

Prof Eva Ekvall Hansson
Public, Scientific, Principal investigator

Forum Medicum Sölvegatan 19
Lund
22362
Sweden

ORCiD logoORCID ID 0000-0001-7552-6486
Phone 0706398663
Email eva.ekvall_hansson@med.lu.se

Study information

Primary study designInterventional
Study designPilot and feasibility study of a randomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleVirtual reality for optimizing rehabilitation for older people with multisensory dizziness - a pilot and feasibility RCT.
Study objectives The aim is to study the feasibility of a future randomized controlled trial. The future RCT will study the effect of adding training with Virtual Reality to ordinary vestibular rehabilitation treatment for older people with multisensory dizziness.
Ethics approval(s)

Approved 02/04/2025, The Swedish Ethical Authority (Box 110, SE 750 02, Uppsala, 750 02, Sweden; 010-475 08 00; registrator@etikprovning.se), ref: 2024-08582-01

Health condition(s) or problem(s) studiedMultisensory dizziness
InterventionPeople with multisensory dizziness have not responded satisfactorily to treatment with vestibular rehabilitation (TAU). Virtual Reality might offer possibilities to challenge the balance system and initiate a reweighting from vision to other sensory systems.

This study assesses Virtual Reality added to vestibular rehabilitation compared to vestibular rehabilitation alone. The Virtual Reality interventions include watching a Virtual Reality movie for balance challenging tasks, twice a week for 9 weeks and performing vestibular rehabilitation exercises daily at home for 9 weeks. The control intervention includes vestibular rehabilitation exercises daily at home for 9 weeks only.

A physiotherapist will assess all patients, individualize the home exercises and assist during Virtual Reality sessions.

Vestibular rehabilitation is performed by means of home exercises, through a written program with text and figures. Virtual Reality sessions are performed face-to-face.

Assessments and Virtual Reality sessions take place at the balance laboratory at the ENT department at Skåne University Hospital in Lund.

Both groups do home exercises for about 15 minutes every day. The Virtual Reality group watches a Virtual Reality movie twice a week, every session taking about 10-15 minutes. Both interventions are performed for 9 weeks.
Intervention typeBehavioural
Primary outcome measure(s)

Feasibility will be assessed by measuring the following using study data at the 9-week follow-up:
1. Retention rate, calculated as a percentage of the individuals who completed the intervention
2. Recruitment rate, calculated as the percentage of eligible individuals who agree to participate
3. The ability to collect outcomes at baseline and follow-up, calculated as a percentage of completed collected data at baseline and follow-up
4. Adverse events, calculated as the number of harmful or negative events that may have influenced the study procedure

Key secondary outcome measure(s)

The following secondary outcome measures are assessed at baseline and at 9-week follow-up:
1. Postural sway in the anterior-posterior and medio-lateral directions will be measured using a 3-second posturography test with a force plate under eyes-open and eyes-closed conditions
2. Vestibular and central eye-movement will be measured by Video Oculography (VOG) and the Video Head Impulse Test (vHIT)
3. Spatial orientation will be measured using the same device as in the VOG and vHIT tests
4. Vibration sense will be measured using a tuning fork applied to the malleolus, monofilament testing with varying distances between two blunt plastic sticks applied to the toes, and biothesiometer testing with a vibrating plastic stick applied to the toes

Completion date30/06/2026

Eligibility

Participant type(s)Patient
Age groupMixed
Lower age limit64 Years
Upper age limit100 Years
SexAll
Target sample size at registration20
Key inclusion criteriaThe diagnosis of multisensory dizziness
Key exclusion criteriaNot meeting the ket inclusion criteria
Date of first enrolment01/11/2025
Date of final enrolment30/06/2026

Locations

Countries of recruitment

  • Sweden

Study participating centre

ENT deparment, Skane University Hospital in Lund
Lasarettsgatan 21
Lund
SE22241
Sweden

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Prof Eva Ekvall Hansson, eva.ekvall_hansson@med.lu.se
• The type of data that will be shared: All secondary outcome measures.
• Timing for availability: After publication of the study
• Whether consent from participants was required and obtained: Yes, consent from participants is required and will be obtained.
• Comments on data anonymization: All data will be anonymized and only data at a group level will be shared.
• Any ethical or legal restrictions: No individual data can be shared.
• Any additional comments: None

Editorial Notes

21/10/2025: Study's existence confirmed by the Swedish Ethical Authority, Sweden.