Parkinson DiseaseVesti-PDNCT05690308
Visual Perturbation Training to Reduce Fall Risk in People with Parkinson's Disease
A study testing Visual perturbation treadmill training and Regular treadmill training in people with Parkinson Disease and Vestibular Disorder, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Falls during walking are common in people with Parkinson's Disease (PD). Fall risk can be attributed in part to the loss of automaticity in walking and an increased reliance on sensory cues, such as the input from the balance organ. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Parkinson Disease, Vestibular Disorder, Gait
- What is being tested?
- Visual perturbation treadmill training and Regular treadmill training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Dec 2022to 13 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease
- Aged between 50-65 years
- Bilateral symptoms
- Able to walk unassisted for 20 minutes (Hoehn \& Yahr stage II-III)
- Stable medication dosage (if any)
- No cognitive disablity
Who cannot join
- Non-idiopathic Parkinson's disease
- Strong variation in expressed symptoms
- Inability to walk unassisted for 20 minutes
- Underwent a medical procedure to treat Parkinson symptoms (e.g. duodopa pump, deep brain stimulator)
- Cognitive disability (score < 21 on the Montreal Cognitive Assessment)
- Illness other than Parkinson's disease (flu, Covid-19) or disabilities that may affect gait or equilibrium
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- Clogged ear(s)
- Regular fainting episodes
- Weight over 120 kg
- Participation in other clinical studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Training Method to Reduce Fall Risk in People with Parkinson's Disease: the Role of the Balance Organ
Falls during walking are common in people with Parkinson's Disease (PD). Fall risk can be attributed in part to the loss of automaticity in walking and an increased reliance on sensory cues, such as the input from the balance organ. In this project the investigators want to assess the effectiveness of rehabilitation training aiming to improve this vestibular input. The effects of a visual perturbation training in a virtual reality environment will be compared to conventional treadmill training.
Read the detailed description
Fifty participants (50-65 years) with idiopathic PD (Hoehn \& Yahr scale 2-3) will be randomly assigned to the intervention group receiving four weeks of VPT in a VR environment using the Gait Real-time Analysis Interactive Lab system (GRAIL) or a control group receiving four weeks of regular treadmill training. Primary outcome measures are spatio-temporal outcome parameters of gait and dynamic stability (gait speed, stride time/length, cadence, step-to-step variability, step width variability and trunk sway), and self-reported falls, and will be recorded at all testing phases (pre-test, after baseline, after intervention and after detraining). Secondary outcome measures will include assessments of central and peripheral vestibular function (Cervical and ocular Vestibular Evoked Myogenic Potentials) for correlation with the primary outcome measures. The secondary outcomes will be recorded at pre-testing and directly after the intervention phase.
- Conditions
- Parkinson Disease, Vestibular Disorder, Gait, Falling
- Being tested
- Visual perturbation treadmill training, Regular treadmill training
- Keywords
- Virtual reality
- Medical subject headings
- Parkinson Disease, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual perturbation treadmill trainingOther
12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill in a virtual reality environment (Gait Real-time Analysis Interactive Lab system, MOTEK) with projected visual perturbations.
Regular treadmill trainingOther
12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill
| Study group | Role | What they receive |
|---|---|---|
| Experimental visual perturbation treadmill training | Experimental | Participants assigned to the experimental intervention will receive 6 weeks, 2x per week of visual perturbation treadmill training using the GRAIL system. This will consist of maximum 30 minutes of walking on the treadmill while translations and rotations of the projected environment are applied. Receives: Other: Visual perturbation treadmill training |
| Control treadmill training | Sham comparator | Participants assigned to the control intervention will receive 6 weeks, 2x per week of treadmill only training. This will consist of maximum 30 minutes of walking on the treadmill without any visual perturbations. Receives: Other: Regular treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in gait speed after 6 weeks training
Delta in average gait speed in m/s
Measured: Week 1 to week 6 of training intervention
Change from baseline in cadence after 6 weeks training
Delta in steps per minute
Measured: Week 1 to week 6 of training intervention
Change from baseline in stride time after 6 weeks training
Delta in average duration (+variability) of a single step in ms
Measured: Week 1 to week 6 of training intervention
Change from baseline in step length after 6 weeks training
Delta in average length (+variability) of a single step in cm
Measured: Week 1 to week 6 of training intervention
Change from baseline in step width after 6 weeks training
Delta in average width(+variability) of a single step in cm
Measured: Week 1 to week 6 of training intervention
Change from baseline in trunk sway after 6 weeks training
Delta in medio-lateral and anterior-posterior movement of the center of mass as determined using 3D motion capturing in cm
Measured: Week 1 to week 6 of training intervention
Secondary outcomes (3)
Assessments of central and peripheral vestibular function
Cervical and ocular vestibular evoked myogenic potentials
Measured: Pre-test 1 at start of the study
Assessments of central and peripheral vestibular function
Cervical and ocular vestibular evoked myogenic potentials
Measured: Post-test within 1 week after conclusion of the training intervention
Self-reported falls
Falls recorded in fall diary
Measured: Monthly up to six months after last training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start20 Dec 2022
- Primary completion30 Mar 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Santens, Prof., Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690308
- Sponsor's protocol ID
- ONZ-2022-0404
- Acronym
- Vesti-PD
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baggen RJ, Van Bladel A, Prins MR, Stappers J, Spildooren J, De Letter M, Bouche K, Cambier D, Maes L, Santens P. Visual perturbation training to reduce visual dependency in Parkinson's disease: A randomized controlled trial. PLoS One. 2026 Mar 2;21(3):e0343223. doi: 10.1371/journal.pone.0343223. eCollection 2026.
PubMed 41770816
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Training Method to Reduce Fall Risk in People with Parkinson's Disease: the Role of the Balance Organ
- ClinicalTrials.gov ID
- NCT05690308
- Acronym / sponsor ID
- Vesti-PD / ONZ-2022-0404
- Conditions
- Parkinson Disease, Vestibular Disorder, Gait, Falling
- Keywords
- Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Falls during walking are common in people with Parkinson's Disease (PD). Fall risk can be attributed in part to the loss of automaticity in walking and an increased reliance on sensory cues, such as the input from the balance organ. In this project the investigators want to assess the effectiveness of rehabilitation training aiming to improve this vestibular input. The effects of a visual perturbation training in a virtual reality environment will be compared to conventional treadmill training.
Detailed description
Fifty participants (50-65 years) with idiopathic PD (Hoehn \& Yahr scale 2-3) will be randomly assigned to the intervention group receiving four weeks of VPT in a VR environment using the Gait Real-time Analysis Interactive Lab system (GRAIL) or a control group receiving four weeks of regular treadmill training. Primary outcome measures are spatio-temporal outcome parameters of gait and dynamic stability (gait speed, stride time/length, cadence, step-to-step variability, step width variability and trunk sway), and self-reported falls, and will be recorded at all testing phases (pre-test, after baseline, after intervention and after detraining). Secondary outcome measures will include assessments of central and peripheral vestibular function (Cervical and ocular Vestibular Evoked Myogenic Potentials) for correlation with the primary outcome measures. The secondary outcomes will be recorded at pre-testing and directly after the intervention phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental visual perturbation treadmill training | Experimental | Other: Visual perturbation treadmill trainingParticipants assigned to the experimental intervention will receive 6 weeks, 2x per week of visual perturbation treadmill training using the GRAIL system. This will consist of maximum 30 minutes of walking on the treadmill while translations and rotations of the projected environment are applied. |
| Control treadmill training | Sham comparator | Other: Regular treadmill trainingParticipants assigned to the control intervention will receive 6 weeks, 2x per week of treadmill only training. This will consist of maximum 30 minutes of walking on the treadmill without any visual perturbations. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Idiopathic Parkinson's disease
- Aged between 50-65 years
- Bilateral symptoms
- Able to walk unassisted for 20 minutes (Hoehn \& Yahr stage II-III)
- Stable medication dosage (if any)
Key exclusion criteria (10 listed)
- Non-idiopathic Parkinson's disease
- Strong variation in expressed symptoms
- Inability to walk unassisted for 20 minutes
- Underwent a medical procedure to treat Parkinson symptoms (e.g. duodopa pump, deep brain stimulator)
- Cognitive disability (score < 21 on the Montreal Cognitive Assessment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual perturbation treadmill training12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill in a virtual reality environment (Gait Real-time Analysis Interactive Lab system, MOTEK) with projected visual perturbations. | Other | Experimental visual perturbation treadmill training |
| Regular treadmill training12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill | Other | Control treadmill training |
Primary outcome
Change from baseline in gait speed after 6 weeks training
Time frame: Week 1 to week 6 of training intervention
Delta in average gait speed in m/s
Change from baseline in cadence after 6 weeks training
Time frame: Week 1 to week 6 of training intervention
Delta in steps per minute
Change from baseline in stride time after 6 weeks training
Time frame: Week 1 to week 6 of training intervention
Delta in average duration (+variability) of a single step in ms
Change from baseline in step length after 6 weeks training
Time frame: Week 1 to week 6 of training intervention
Delta in average length (+variability) of a single step in cm
Change from baseline in step width after 6 weeks training
Time frame: Week 1 to week 6 of training intervention
Delta in average width(+variability) of a single step in cm
Change from baseline in trunk sway after 6 weeks training
Time frame: Week 1 to week 6 of training intervention
Delta in medio-lateral and anterior-posterior movement of the center of mass as determined using 3D motion capturing in cm
3 secondary outcomes
Assessments of central and peripheral vestibular function
Time frame: Pre-test 1 at start of the study
Assessments of central and peripheral vestibular function
Time frame: Post-test within 1 week after conclusion of the training intervention
Self-reported falls
Time frame: Monthly up to six months after last training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41770816Baggen RJ, Van Bladel A, Prins MR, Stappers J, Spildooren J, De Letter M, Bouche K, Cambier D, Maes L, Santens P. Visual perturbation training to reduce visual dependency in Parkinson's disease: A randomized controlled trial. PLoS One. 2026 Mar 2;21(3):e0343223. doi: 10.1371/journal.pone.0343223. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Santens, Prof. principal investigator
UZ Gent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual perturbation treadmill training and Regular treadmill training in people with Parkinson Disease and Vestibular Disorder, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in gait speed after 6 weeks training (time frame: Week 1 to week 6 of training intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05690308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.