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

NCT ID: NCT05690308

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2024-05-13

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.

Conditions

Parkinson Disease; Vestibular Disorder; Gait; Falling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Visual perturbation treadmill training

Intervention Type: OTHER

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.

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.

Group Type: SHAM_COMPARATOR

Regular treadmill training

Intervention Type: OTHER

12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill

Interventions

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.

Intervention Type: OTHER

Regular treadmill training

12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Santens, Prof.

Role: PRINCIPAL_INVESTIGATOR

UZ Gent

Locations

UZ Gent

Ghent, East-Flanders, Belgium

Countries

Belgium

Other Identifiers

ONZ-2022-0404

Identifier Type: -

Identifier Source: org_study_id