Clinical trial NCT05690308: Visual Perturbation Training to Reduce Fall Risk in People with Parkinson's Disease
Official title: A Novel Training Method to Reduce Fall Risk in People with Parkinson's Disease: the Role of the Balance Organ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Vestibular Disorder
Gait
Falling
Keywords: Virtual reality
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in gait speed after 6 weeks training
timeFrame: Week 1 to week 6 of training intervention
measure: Change from baseline in cadence after 6 weeks training
timeFrame: Week 1 to week 6 of training intervention
measure: Change from baseline in stride time after 6 weeks training
timeFrame: Week 1 to week 6 of training intervention
measure: Change from baseline in step length after 6 weeks training
timeFrame: Week 1 to week 6 of training intervention
measure: Change from baseline in step width after 6 weeks training
timeFrame: Week 1 to week 6 of training intervention
measure: Change from baseline in trunk sway after 6 weeks training
timeFrame: Week 1 to week 6 of training intervention
Secondary outcomes:
measure: Assessments of central and peripheral vestibular function
timeFrame: Pre-test 1 at start of the study
measure: Assessments of central and peripheral vestibular function
timeFrame: Post-test within 1 week after conclusion of the training intervention
measure: Self-reported falls
timeFrame: Monthly up to six months after last training
Other outcomes:
measure: Assessment of fear of falling
timeFrame: Pre-test 2 at start of the study
measure: Assessment of fear of falling
timeFrame: Post-test within 1 week after conclusion of the training intervention
Locations:
city: Ghent
country: Belgium
facility: UZ Gent
state: East-Flanders
Study officials:
affiliation: UZ Gent
name: Patrick Santens, Prof.
role: PRINCIPAL_INVESTIGATOR
References: