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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Falling; Parkinson Disease; Gait; Vestibular Disorder

Treatments: Other: Visual perturbation treadmill training; Other: Regular treadmill training

Study type: Interventional

Funder types: Other

Identifiers

NCT05690308

ONZ-2022-0404

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Experimental visual perturbation treadmill training

Experimental group

Description:

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.

Treatment:

Other: Visual perturbation treadmill training

Control treadmill training

Sham Comparator group

Description:

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.

Treatment:

Other: Regular treadmill training