A Novel Training Method to Reduce Fall Risk in People With Parkinson's Disease: The Role of the Balance Organ
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- University Ghent
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Change from baseline in stride time after 6 weeks training
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change from baseline in stride time after 6 weeks training
Time Frame: Week 1 to week 6 of training intervention
Delta in average duration (+variability) of a single step in ms
Change from baseline in step width after 6 weeks training
Time Frame: Week 1 to week 6 of training intervention
Delta in average width(+variability) of a single step in cm
Change from baseline in gait speed after 6 weeks training
Time Frame: Week 1 to week 6 of training intervention
Delta in average gait speed in m/s
Change from baseline in cadence after 6 weeks training
Time Frame: Week 1 to week 6 of training intervention
Delta in steps per minute
Change from baseline in step length after 6 weeks training
Time Frame: Week 1 to week 6 of training intervention
Delta in average length (+variability) of a single step in cm
Change from baseline in trunk sway after 6 weeks training
Time Frame: Week 1 to week 6 of training intervention
Delta in medio-lateral and anterior-posterior movement of the center of mass as determined using 3D motion capturing in cm
Secondary Outcomes
- Assessments of central and peripheral vestibular function(Post-test within 1 week after conclusion of the training intervention)
- Self-reported falls(Monthly up to six months after last training)