Parkinson Disease Clinical Trial
— Vesti-PDOfficial title:
A Novel Training Method to Reduce Fall Risk in People With Parkinson's Disease: The Role of the Balance Organ
Verified date | May 2024 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Gent | Ghent | East-Flanders |
Lead Sponsor | Collaborator |
---|---|
University Ghent |
Belgium,
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 |
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