Balance training through perceptual training
| ISRCTN | ISRCTN15821503 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15821503 |
| Secondary identifying numbers | PL2 |
- Submission date
- 16/10/2023
- Registration date
- 24/10/2023
- Last edited
- 06/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
As people get older, their ability to maintain balance tends to decline, especially after reaching the age of 65. This makes them more prone to falling, and it's not uncommon for many seniors to experience at least one fall in a year.
In our research, we are working to reduce the risk of falls among older individuals by using a special motion device that stimulates the part of the inner ear responsible for balance, called the vestibular system. Previous studies have demonstrated that it's possible to improve one's sense of balance through this kind of training. Additionally, a study conducted in our department has shown promising results, although it has not been officially published yet.
Who can participate?
We will recruit 90 healthy volunteers from the age of 65 and above.
What does the study involve?
The experiment will take 12 days in which the participants will undergo several tests. On the first day, we assess rs-fMRI, VestEP, gait, posture, and vestibular perpetual threshold. From day 2 to day 9 the participants will be divided into 3 groups. One group will be trained on a motion device (perceptual training), one group will be trained by a personal trainer in Tai Chi (exercise), and the last group will receive no training (control). All participants will be tested again on day 10, day 40, and 90 (day 40 and 90 are follow-ups).
What are the possible benefits and risks of participating?
Participants have no risks in this study nor any real benefits. We hope to develop a treatment with which we could train senior citizens vestibular threshold and thereby increase their sense of balance. This would reduce the dangers of falling and could be applied to patients that are temporarily immobilized or in rehabilitation.
Where is the study run from?
University of Bern (Switzerland)
When is the study starting and how long is it expected to run for?
October 2023 to May 2026
Who is funding the study?
University of Bern (Switzerland)
Who is the main contact?
Dr Matthias Ertl
studie-kwm@unibe.ch or matthias.ertl@unibe.ch
Contact information
Public, Scientific, Principal Investigator
Fabrikstrasse 8
Bern
3012
Switzerland
 ORCID ID |
0000-0002-6823-1935 |
|---|---|
| Phone | +41 31 684 54 35 |
| matthias.ertl@unibe.ch |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Laboratory |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Vestibular perceptual training in healthy people |
| Study acronym | VPT |
| Study objectives | We expect to see improvements in the vestibular perceptual thresholds. An improvement is defined as a smaller threshold in the post compared to the pre-training measurement. The groups with vestibular perceptual training (TVPT) and physical activity training (TPA) are expected to show a decrease in vestibular perceptual thresholds (improvement) when comparing participants within subject and when comparing training groups to controls (Tno). |
| Ethics approval(s) |
Approved 20/12/2023, Swissethics, Schweizerische Vereinigung der Forschungsethikkommissionen (Haus der Akademien, Laupenstrasse 7, Bern, CH-3000, Switzerland; +41 31 306 93 95; info@swissethics.ch), ref: 2023-01586 |
| Health condition(s) or problem(s) studied | Vestibular threshold degregation |
| Intervention | We will compare individual pre- and post-training performance, as well as group pre- and post-training performance. There will be 3 groups: vestibular stimulation training, Tai Chi training, and no training. There won't be any blinding, as it is not possible. Participants will be tested and trained during 10 days and will be tested again on days 40 and 90. Group 1 will receive a vestibular perceptual threshold training. During this training the participant will be seated on a motion device while blinded and muted to external sounds. The motion device will then move in a roll or tilt motion to either the right or the left and the participants task will be to guess in which direction they were moved. This will take 1h. Group 2 will receive 1h Tai Chi training from a personal instructor. Group 3 will receive no training whatsoever and will only be tested on day 1 and 10 |
| Intervention type | Behavioural |
| Primary outcome measure | 1. For the vestibular perceptual threshold (VPT) we measure whether the participants can feel in which direction they have been moved (threshold) to either the left or right using a motion device on day 1 (baseline), day 10 (post training), day 40 (follow-up 1), and day 90 (follow-up 2). 2. For the VestEPs we measure the ERP amplitudes (P1, N1. P2) on day 1 (baseline), day 10 (post training), day 40 (follow-up 1), and day 90 (follow-up 2). 3. With the rs-fMRI we measure Connectivity within the cortical vestibular network (OP2, Csv), Connectivity between the vestibular (OP2) and motor system (M1), and cortical thickness on day 1 (baseline), day 10 (post training), day 40 (follow-up 1), and day 90 (follow-up 2). 4. For gait and posture, we measure the acceleration signals on day 1 (baseline), day 10 (post training), day 40 (follow-up 1), and day 90 (follow-up 2). |
| Secondary outcome measures | 1. For the VPT we measure the response times on day 1 (baseline), day 10 (post training), day 40 (follow-up 1), and day 90 (follow-up 2). 2. For the VestEPs we measure the latencies of the ERP amplitudes, time-frequency decomposition analysis of the ERPs, source localization of the ERPs, and a dynamic causal model (DCM) describing the within network alterations over time on day 1 (baseline), day 10 (post training), day 40 (follow-up 1), and day 90 (follow-up 2). 3. For the rs-fMIR we measure volumetric changes on day 1 (baseline), day 10 (post training), day 40 (follow-up 1), and day 90 (follow-up 2). 4. For gait we measure walking duration for the predefined distance on day 1 (baseline), day 10 (post training), day 40 (follow-up 1), and day 90 (follow-up 2). 5. For posture we measure on the stair-condition if participants make use of the hand grip on day 1 (baseline), day 10 (post training), day 40 (follow-up 1), and day 90 (follow-up 2). |
| Overall study start date | 16/10/2023 |
| Completion date | 01/05/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 135 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | Healthy participants from the age of 65 with no neurological diagnosis or physical disabilities within the Bern region will be recruited for this study. |
| Key exclusion criteria | 1. Neurologic signs indicative of vertigo due to a central lesion 2. Patients with additional severe cardio-vascular, metabolic, neurological, or degenerative diseases 3. Ear/Vestibular diseases or disorders 4. Intake of neuroleptics or other medication with potential effects on cognition or cause nausea 5. Pregnancy 6. Persons with a pacemaker or other metal in the body which could interfere with the scanner. 7. Implantable Cardioverter Defibrillator 8. Hearing loss 9. Cochlea implant 10. Epilepsy |
| Date of first enrolment | 16/02/2024 |
| Date of final enrolment | 01/02/2026 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Bern
3012
Switzerland
Sponsor information
University/education
Fabrikstrasse 8
Bern
3012
Switzerland
| Phone | +41 31 684 40 42 |
|---|---|
| fred.mast@unibe.ch | |
| Website | https://www.unibe.ch/index_ger.html |
"ROR" |
https://ror.org/02k7v4d05 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Universität Bern, Université de Berne, Universitas Bernensis, UniBE, جامعة برن, Бернскі ўніверсітэт, Бернски университет, Universitat de Berna, Bernská univerzita, Πανεπιστήμιο της Βέρνης, Universitato de Berno, Universidad de Berna, Berni Ülikool, Bernako Unibertsitatea, دانشگاه برن, Bernin yliopisto, Univèrsitât de Bèrna, Universidade de Berna, אוניברסיטת ברן, Università di Berna, ベルン大学, Берн университеті, 베른 대학교, Berno universitetas, Universiteit van Bern, Universitetet i Bern, Бернский университет, Bern Üniversitesi, Берн университеты, Бернський університет, 伯尔尼大学, UB
- Location
- Switzerland
Results and Publications
| Intention to publish date | 01/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from https://osf.io/jn2yp/ Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). |
Editorial Notes
06/03/2025: The secondary identifying number was corrected.
26/02/2024: Ethics approval date was added.
19/01/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/12/2023 to 16/02/2024.
2. The recruitment end date was changed from 01/09/2025 to 01/02/2026.
3. The overall end date was changed from 01/01/2026 to 01/05/2026.
19/10/2023: Trial's existence confirmed by Neurologische Poliklinik Inselspital.
