Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690308
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2022-09-01
Brief Title:
Visual Perturbation Training to Reduce Fall Risk in People with Parkinsons Disease
Sponsor:
University Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
A Novel Training Method to Reduce Fall Risk in People with Parkinsons Disease the Role of the Balance Organ
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Vesti-PD
Brief Summary:
Falls during walking are common in people with Parkinsons 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 timelength 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None