Skip to content

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

A Novel Training Method to Reduce Fall Risk in People with Parkinson's Disease: the Role of the Balance Organ

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05690308
Acronym
Vesti-PD
Enrollment
35
Registered
2023-01-19
Start date
2022-12-20
Completion date
2024-05-13
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falling, Gait, Parkinson Disease, Vestibular Disorder

Keywords

Virtual reality

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.

Interventions

OTHERVisual 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.

OTHERRegular treadmill training

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

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will not be informed if they are allocated to the experimental intervention or the control 'sham' intervention.

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in trunk sway after 6 weeks trainingWeek 1 to week 6 of training interventionDelta in medio-lateral and anterior-posterior movement of the center of mass as determined using 3D motion capturing in cm
Change from baseline in stride time after 6 weeks trainingWeek 1 to week 6 of training interventionDelta in average duration (+variability) of a single step in ms
Change from baseline in step length after 6 weeks trainingWeek 1 to week 6 of training interventionDelta in average length (+variability) of a single step in cm
Change from baseline in step width after 6 weeks trainingWeek 1 to week 6 of training interventionDelta in average width(+variability) of a single step in cm
Change from baseline in gait speed after 6 weeks trainingWeek 1 to week 6 of training interventionDelta in average gait speed in m/s
Change from baseline in cadence after 6 weeks trainingWeek 1 to week 6 of training interventionDelta in steps per minute

Secondary

MeasureTime frameDescription
Assessments of central and peripheral vestibular functionPre-test 1 at start of the studyCervical and ocular vestibular evoked myogenic potentials
Self-reported fallsMonthly up to six months after last trainingFalls recorded in fall diary

Other

MeasureTime frameDescription
Assessment of fear of fallingPre-test 2 at start of the studyFear of falling recorded using the Iconographical Falls Efficacy Scale

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026