Visual Perturbation Training to Reduce Fall Risk in People With Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Novel Training Method to Reduce Fall Risk in People With Parkinson's Disease: The Role of the Balance Organ

Conditions
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Parkinson Disease, Vestibular Disorder, Gait, Falling

Intervention / Treatment
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* Other: Visual perturbation treadmill training
* Other: Regular treadmill training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Clogged ear(s) Regular fainting episodes Weight over 120 kg Participation in other clinical studies

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental visual perturbation treadmill training<br>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. | Other: Visual perturbation treadmill training<br>* 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.<br>|
| Sham Comparator: Control treadmill training<br>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. | Other: Regular treadmill training<br>* 12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in gait speed after 6 weeks training | Delta in average gait speed in m/s | Week 1 to week 6 of training intervention | 
| Change from baseline in cadence after 6 weeks training | Delta in steps per minute | 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 | 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 | 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 | 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 | Week 1 to week 6 of training intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessments of central and peripheral vestibular function | Cervical and ocular vestibular evoked myogenic potentials | Pre-test 1 at start of the study | 
| Assessments of central and peripheral vestibular function | Cervical and ocular vestibular evoked myogenic potentials | Post-test within 1 week after conclusion of the training intervention | 
| Self-reported falls | Falls recorded in fall diary | Monthly up to six months after last training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality