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| Name | Class |
|---|---|
| University Ghent | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's Disease group | Experimental | Patients with stage 3 idiopathic Parkinson's Disease |
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| Healthy control group | Active Comparator | Age and sex-matched healthy adults |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline assessment of demographic, anthropometric and clinical characteristics | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Fall events | Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups. | baseline to 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Walking speed | Walking speed (meters/second) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Years since birth | baseline |
| Sex | Male or female | baseline |
Parkinson's Disease group
Inclusion criteria:
Exclusion criteria:
Healthy control group
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katie Bouche, PhD | University Hospital, Ghent | Principal Investigator |
| Leen Maes, PhD | University Ghent | Principal Investigator |
| Anke Van Bladel, PhD | University Ghent | Principal Investigator |
| Nina Lefeber, PhD | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium | |||
| Ghent University |
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Case-control
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| Baseline assessment of demographic, anthropometric and clinical characteristics | Other |
|
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| Locomotor assessments | Other | First, 9 anthropometric measurements will be taken, 39 reflective markers will be placed, and a 6-min practice walking session will be conducted to familiarize participants with self-paced treadmill walking (SPTW). Thereafter, participants will partake in 7 experimental conditions in a (semi-)randomized order:
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| Speech assessments | Other |
|
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| Audiology assessments | Other |
|
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| Walking cadence | Walking cadence (steps/minute) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands). | 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 | Step length (meters) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands). | 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 | Hip, knee and ankle joint angle during walking (°) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands). | 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 | Hip, knee and ankle joint moment during walking (Nm/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands). | 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 power during walking | Hip, knee and ankle joint moment during power (W/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands). | 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 |
| Freezing of gait | Number of freezing of gait events measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands). | baseline during 6 min self-paced treadmill walking in a virtual environment |
| Spontaneous speech production | Audio recordings analyzed using PRAAT software to assess 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 |
| Spontaneous speech production | Audio recordings analyzed using Motor Speech Profile software to assess 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 |
| Speech Handicap Index | 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. | baseline |
| Otoscopy | A otoscopic test to examine the external auditory canal and the tympanic membrane | baseline |
| Tympanometry | An auditory test to assess the middle-ear function | baseline |
| Pure tone audiometry | An auditory test to assess hearing threshold levels | baseline |
| Otoacoustic Emissions Test | An auditory test to measure cochlear outer hair cell function | baseline |
| Video Head Impuls Test | A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals | baseline |
| Cervical Vestibular Evoked Myogenic Potential Testing | A vestibular function test to assess the saccular and inferior vestibular nerve function | baseline |
| Ocular Vestibular Evoked Myogenic Potential Testing | A vestibular function test to assess the utricular and superior vestibular nerve function | baseline |
| Ocular Motor Testing | A vestibular function test to evaluate oculomotor function | baseline |
| Dix-Hallpike Test | A diagnostic maneuver to identify benign paroxysmal positional vertigo | baseline |
| Roll Test | A diagnostic maneuver to identify benign paroxysmal positional vertigo | baseline |
| Static visual acuity | Static visual acuity measured using a Snellen chart (static logMAR) | baseline |
| Dynamic visual acuity | Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR) | baseline |
| Dizziness Handicap Inventory | 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. | baseline |
| Montreal Cognitive Assessment |
A screening test to assess global cognition (0-30). Higher scores indicate better performance. |
| baseline |
| Shortened Iconographical Falls Efficacy Scale | A 10-item scale to assess fear of falling. Each item is scored on a 4-point scale (1 = not at all concerned to 4 = very concerned). | baseline |
| Fall history | Number of falls in the past month | baseline |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I | A 13-item rating scale to assess non-motor experiences of daily living (0-52). Higher scores indicate a worse outcome. | baseline |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III | An 18-item motor examination to assess motor symptoms (0-132). Higher scores indicate a worse outcome. | baseline |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV | A 6-item rating scale to assess motor complications. Higher scores indicate a worse outcome. | baseline |
| Hoehn and Yahr scale | A scale to assess disease severity/progression (0-5). Higher scores indicate more severe symptoms. | baseline |
| New Freezing of Gait Questionnaire | A 9-item questionnaire to assess freezing of gait severity (0-28). Higher scores indicate more severe freezing of gait. | baseline |
| Time since diagnosis | The number of days since the diagnosis of Parkinson's Disease | baseline |
| Blood pressure | The ratio of systolic over diastolic blood pressure (mm Hg) | baseline |
| Medication | Number, type and dose (mg) of medication | baseline |
| Ghent |
| 9000 |
| Belgium |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D013060 | Speech |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
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