Factors Associated With Falling in Parkinson's Disease
- Conditions
- Parkinson Disease
- Registration Number
- NCT04440033
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
The objective of this study will be to identify multidisciplinary fall risk factors in persons with stage 3 idiopathic Parkinson's Disease compared to age and sex-matched healthy adults. Both the relative contribution of each independent factor, as well as the interaction between these factors, will be examined. The study will include multidisciplinary assessments, including locomotor, speech, auditory, vestibular and opthalmologic assessments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Fall events baseline to 6 months after baseline Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.
- Secondary Outcome Measures
Name Time Method Hip, knee and ankle joint moment during walking baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment Hip, knee and ankle joint moment during walking (Nm/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Hip, knee and ankle joint power during walking baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment Hip, knee and ankle joint moment during power (W/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Pure tone audiometry baseline An auditory test to assess hearing threshold levels
Otoacoustic Emissions Test baseline An auditory test to measure cochlear outer hair cell function
Walking cadence baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment Walking cadence (steps/minute) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Step length baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment Step length (meters) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Otoscopy baseline A otoscopic test to examine the external auditory canal and the tympanic membrane
Tympanometry baseline An auditory test to assess the middle-ear function
Walking speed baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment Walking speed (meters/second) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Hip, knee and ankle joint angle during walking baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment Hip, knee and ankle joint angle during walking (°) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Freezing of gait baseline during 6 min self-paced treadmill walking in a virtual environment Number of freezing of gait events measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Spontaneous speech production baseline; baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment Audio recordings analyzed using Motor Speech Profile software to assess spontaneous speech production
Speech Handicap Index baseline A 15-item self-reported questionnaire based on the Parole Handicap Index to evaluate the physical, functional and psychosocial impact of dysarthria (0-60). Higher scores indicate a higher level of speech-related problems.
Video Head Impuls Test baseline A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals
Ocular Motor Testing baseline A vestibular function test to evaluate oculomotor function
Dix-Hallpike Test baseline A diagnostic maneuver to identify benign paroxysmal positional vertigo
Dizziness Handicap Inventory baseline A 25-item self-assessment inventory to evaluate self-perceived handicapping effects of dizziness (0-100). Higher scores indicate a greater perceived handicap due to dizziness.
Static visual acuity baseline Static visual acuity measured using a Snellen chart (static logMAR)
Ocular Vestibular Evoked Myogenic Potential Testing baseline A vestibular function test to assess the utricular and superior vestibular nerve function
Dynamic visual acuity baseline Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)
Cervical Vestibular Evoked Myogenic Potential Testing baseline A vestibular function test to assess the saccular and inferior vestibular nerve function
Roll Test baseline A diagnostic maneuver to identify benign paroxysmal positional vertigo
Trial Locations
- Locations (2)
Ghent University Hospital
🇧🇪Ghent, Belgium
Ghent University
🇧🇪Ghent, Belgium
Ghent University Hospital🇧🇪Ghent, Belgium