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

Not Applicable
Completed
Conditions
Vestibular Disorder
Falling
Gait
Parkinson Disease
Interventions
Other: Visual perturbation treadmill training
Other: Regular treadmill training
Registration Number
NCT05690308
Lead Sponsor
University Ghent
Brief 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. 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
35
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental visual perturbation treadmill trainingVisual 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 trainingRegular 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.
Primary Outcome Measures
NameTimeMethod
Change from baseline in stride time after 6 weeks trainingWeek 1 to week 6 of training intervention

Delta in average duration (+variability) of a single step in ms

Change from baseline in step width after 6 weeks trainingWeek 1 to week 6 of training intervention

Delta in average width(+variability) of a single step in cm

Change from baseline in gait speed after 6 weeks trainingWeek 1 to week 6 of training intervention

Delta in average gait speed in m/s

Change from baseline in cadence after 6 weeks trainingWeek 1 to week 6 of training intervention

Delta in steps per minute

Change from baseline in step length after 6 weeks trainingWeek 1 to week 6 of training intervention

Delta in average length (+variability) of a single step in cm

Change from baseline in trunk sway after 6 weeks trainingWeek 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

Secondary Outcome Measures
NameTimeMethod
Assessments of central and peripheral vestibular functionPost-test within 1 week after conclusion of the training intervention

Cervical and ocular vestibular evoked myogenic potentials

Self-reported fallsMonthly up to six months after last training

Falls recorded in fall diary

Trial Locations

Locations (1)

UZ Gent

🇧🇪

Ghent, East-Flanders, Belgium

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