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

Primary Purpose

Parkinson Disease, Vestibular Disorder, Gait

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Visual perturbation treadmill training
Regular treadmill training
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Virtual reality

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UZ GentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental visual perturbation treadmill training

Control treadmill training

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in gait speed after 6 weeks training
Delta in average gait speed in m/s
Change from baseline in cadence after 6 weeks training
Delta in steps per minute
Change from baseline in stride time after 6 weeks training
Delta in average duration (+variability) of a single step in ms
Change from baseline in step length after 6 weeks training
Delta in average length (+variability) of a single step in cm
Change from baseline in step width after 6 weeks training
Delta in average width(+variability) of a single step in cm
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

Secondary Outcome Measures

Assessments of central and peripheral vestibular function
Cervical and ocular vestibular evoked myogenic potentials
Assessments of central and peripheral vestibular function
Cervical and ocular vestibular evoked myogenic potentials
Self-reported falls
Falls recorded in fall diary

Full Information

First Posted
September 1, 2022
Last Updated
January 9, 2023
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05690308
Brief Title
Visual Perturbation Training to Reduce Fall Risk in People With Parkinson's Disease
Acronym
Vesti-PD
Official Title
A Novel Training Method to Reduce Fall Risk in People With Parkinson's Disease: The Role of the Balance Organ
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Vestibular Disorder, Gait, Falling
Keywords
Virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Participant
Masking Description
Participants will not be informed if they are allocated to the experimental intervention or the control 'sham' intervention.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental visual perturbation treadmill training
Arm Type
Experimental
Arm 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.
Arm Title
Control treadmill training
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Visual perturbation treadmill training
Intervention Description
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
Intervention Name(s)
Regular treadmill training
Intervention Description
12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill
Primary Outcome Measure Information:
Title
Change from baseline in gait speed after 6 weeks training
Description
Delta in average gait speed in m/s
Time Frame
Week 1 to week 6 of training intervention
Title
Change from baseline in cadence after 6 weeks training
Description
Delta in steps per minute
Time Frame
Week 1 to week 6 of training intervention
Title
Change from baseline in stride time after 6 weeks training
Description
Delta in average duration (+variability) of a single step in ms
Time Frame
Week 1 to week 6 of training intervention
Title
Change from baseline in step length after 6 weeks training
Description
Delta in average length (+variability) of a single step in cm
Time Frame
Week 1 to week 6 of training intervention
Title
Change from baseline in step width after 6 weeks training
Description
Delta in average width(+variability) of a single step in cm
Time Frame
Week 1 to week 6 of training intervention
Title
Change from baseline in trunk sway after 6 weeks training
Description
Delta in medio-lateral and anterior-posterior movement of the center of mass as determined using 3D motion capturing in cm
Time Frame
Week 1 to week 6 of training intervention
Secondary Outcome Measure Information:
Title
Assessments of central and peripheral vestibular function
Description
Cervical and ocular vestibular evoked myogenic potentials
Time Frame
Pre-test 1 at start of the study
Title
Assessments of central and peripheral vestibular function
Description
Cervical and ocular vestibular evoked myogenic potentials
Time Frame
Post-test within 1 week after conclusion of the training intervention
Title
Self-reported falls
Description
Falls recorded in fall diary
Time Frame
Monthly up to six months after last training
Other Pre-specified Outcome Measures:
Title
Assessment of fear of falling
Description
Fear of falling recorded using the Iconographical Falls Efficacy Scale
Time Frame
Pre-test 2 at start of the study
Title
Assessment of fear of falling
Description
Fear of falling recorded using the Iconographical Falls Efficacy Scale
Time Frame
Post-test within 1 week after conclusion of the training intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Remco Baggen, PhD
Phone
+32 9 332 46 57
Email
remco.baggen@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Santens, Prof.
Organizational Affiliation
UZ Gent
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Gent
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Santens, PhD.
Email
patrick.santens@ugent.be

12. IPD Sharing Statement

Plan to Share IPD
No

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

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