Visual Perturbation Training to Reduce Fall Risk in People With Parkinson's Disease (Vesti-PD)

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Gait; Vestibular Disorder; Falling
• Intervention / Treatment: Other: Visual perturbation treadmill training; Other: Regular 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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • UZ Gent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental visual perturbation treadmill training; 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; 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.
Sham Comparator: Control treadmill training; 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; 12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of fear of falling	Fear of falling recorded using the Iconographical Falls Efficacy Scale	Pre-test 2 at start of the study
Assessment of fear of falling	Fear of falling recorded using the Iconographical Falls Efficacy Scale	Post-test within 1 week after conclusion of the training intervention

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Patrick Santens, Prof., UZ Gent

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): May 13, 2024

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Estimated): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Virtual reality
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Otorhinolaryngologic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Labyrinth Diseases; Ear Diseases; Parkinson Disease; Vestibular Diseases
• Other Study ID Numbers: ONZ-2022-0404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No