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

Not Applicable

Completed

• Conditions: Vestibular Disorder; Falling; Gait; Parkinson Disease

• 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.

Study Timeline

• Study First Submitted: 2022-09-01
• Study Start: 2022-12-20
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-19
• Primary Completion: 2024-03-30
• Status Verified: 2024-05
• Study Completion: 2024-05-13
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in stride time after 6 weeks training	Week 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 training	Week 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 training	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	Week 1 to week 6 of training intervention	Delta in steps per minute
Change from baseline in step length after 6 weeks training	Week 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 training	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

Secondary Outcome Measures

Name	Time	Method
Assessments of central and peripheral vestibular function	Post-test within 1 week after conclusion of the training intervention	Cervical and ocular vestibular evoked myogenic potentials
Self-reported falls	Monthly up to six months after last training	Falls recorded in fall diary

Trial Locations

Locations (1)

UZ Gent; 🇧🇪 Ghent, East-Flanders, Belgium