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

Parkinson Disease Clinical Trial

— Vesti-PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690308
• Other study ID #: ONZ-2022-0404
• Status: Completed
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: May 13, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 13, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Falling
• Gait
• Parkinson Disease
• Vestibular Diseases
• Vestibular Disorder

Intervention

Other:
• 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.
• Regular treadmill training
12 sessions of (max 30 minutes) walking at comfortable speed on an instrumented treadmill

Locations

Country	Name	City	State
Belgium	UZ Gent	Ghent	East-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of fear of falling	Fear of falling recorded using the Iconographical Falls Efficacy Scale	Pre-test 2 at start of the study
Other	Assessment of fear of falling	Fear of falling recorded using the Iconographical Falls Efficacy Scale	Post-test within 1 week after conclusion of the training intervention
Primary	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
Primary	Change from baseline in cadence after 6 weeks training	Delta in steps per minute	Week 1 to week 6 of training intervention
Primary	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
Primary	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
Primary	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
Primary	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	Assessments of central and peripheral vestibular function	Cervical and ocular vestibular evoked myogenic potentials	Pre-test 1 at start of the study
Secondary	Assessments of central and peripheral vestibular function	Cervical and ocular vestibular evoked myogenic potentials	Post-test within 1 week after conclusion of the training intervention
Secondary	Self-reported falls	Falls recorded in fall diary	Monthly up to six months after last training