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

NCT05690308 | Completed

• 1 other identifier: ONZ-2022-0404
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Vestibular Disorder; Gait; Falling

Keywords

Virtual reality

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Assessments of central and peripheral vestibular function

  Pre-test 1 at start of the study

• Assessments of central and peripheral vestibular function

  Post-test within 1 week after conclusion of the training intervention

• Self-reported falls

  Monthly up to six months after last training

Other Outcomes (2)

• Assessment of fear of falling

  Pre-test 2 at start of the study

• Assessment of fear of falling

  Post-test within 1 week after conclusion of the training intervention

Study Arms (2)

Experimental visual perturbation treadmill training

EXPERIMENTAL

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

Control treadmill training

SHAM COMPARATOR

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

Interventions

Visual perturbation treadmill training 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.

Experimental visual perturbation treadmill training

Regular treadmill training OTHER

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

Control treadmill training

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

UZ Gent

Ghent, East-Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Parkinson Disease; Vestibular Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Patrick Santens, Prof.

  UZ Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed if they are allocated to the experimental intervention or the control 'sham' intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: January 19, 2023
• Study Start: December 20, 2022
• Primary Completion: March 30, 2024
• Study Completion: May 13, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)