Factors Associated With Falling in Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Factors Associated With Falling in Parkinson's Disease: a Multidisciplinary Prospective Study

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Baseline assessment of demographic, anthropometric and clinical characteristics
* Other: Baseline assessment of demographic, anthropometric and clinical characteristics
* Other: Locomotor assessments
* Other: Speech assessments
* Other: Audiology assessments


Participation Criteria
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Eligibility Criteria
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Parkinson's Disease group Inclusion criteria: Persons with idiopathic PD diagnosed by a medical doctor according to the United Kingdom PD Brain Bank Criteria Aged between 18 and 75 years-old Stage 3 on the Hoehn and Yahr scale in the on-medication state On a stable dose of PD medication (at least one week) Able to stand and walk on a treadmill without support for at least 3 minutes Able to give consent Exclusion criteria: Atypical parkinsonism Unpredictable symptom fluctuations Previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy) Duodopa pump therapy Dementia (Montreal Cognitive Assessment (MoCA) < 21)[1] Symptomatic orthostatic hypotension (e.g. frequent syncope episodes) Concurrent neurological disorders (e.g. stroke) Comorbidities that affect gait or balance (e.g. peripheral neuropathy) Acute illness Epilepsy or history of seizures Depression (MDS-UPDRS item 1.3 ≥ 2) Body weight over 120 kilograms Pregnancy Participation in other ongoing experimental trials Healthy control group Inclusion criteria: Age and sex-matched healthy adults Exclusion criteria: Symptomatic orthostatic hypotension (e.g. frequent syncope episodes) Body weight over 120 kilograms Pregnancy Participation in other ongoing experimental trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Case-control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parkinson's Disease group<br>Patients with stage 3 idiopathic Parkinson's Disease | Other: Baseline assessment of demographic, anthropometric and clinical characteristics<br>* Age Sex Height Body weight Handedness Medication use Blood pressure Global cognition (Montreal Cognitive Assessment) Fear of falling (Shortened Iconographical Falls Efficacy Scale) History of falls (number of falls in the past month) Time since diagnosis and symptom onset Disease severity (UPDRS part III, Hoehn and Yahr) Non-motor symptoms (UPDRS part I) Motor symptoms (UPDRS part III) Motor complications (UPDRS part IV) Disease-dominant side (UPDRS part III) Freezing of gait (New Freezing of Gait Questionnaire)<br>Other: Locomotor assessments<br>* 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: 3 min standing 3 min standing while answering semi-standardized questions 3 min SPTW 3 min SPTW while answering semi-standardized questions (SPTW-Q) 3 min SPTW while verbally describing a VR environment (SPTW-VR1) 6 min SPTW in a VR environment containing freezing of gait provoking elements (SPTW-VR2)<br>Other: Speech assessments<br>* Acoustic analysis (including voice reports and formant analysis), video recording and motor speech profile (including analysis of diadochokinesis, voice, standard syllabic rate, intonation and second formant (F2)). Spontaneous speech production will be assessed by answering semi-standardized questions based on the Aachen Aphasia Test and by describing a VR environment projected on a 180-degree cylindrical screen The Speech Handicap Index (a 15-item self-reported questionnaire)<br>Other: Audiology assessments<br>* Otoscopy Tympanometry Pure tone audiometry Otoacoustic emissions Video Head Impuls Test Cervical Vestibular Evoked Myogenic Potentials Ocular Vestibular Evoked Myogenic Potentials Oculomotor function testing Positional testing Static visual acuity test Dynamic visual acuity test Dizziness Handicap Inventory (a 25-item self-assessment inventory)<br>|
| Active Comparator: Healthy control group<br>Age and sex-matched healthy adults | Other: Baseline assessment of demographic, anthropometric and clinical characteristics<br>* Age Sex Height Body weight Handedness Medication use Blood pressure Global cognition (Montreal Cognitive Assessment) Fear of falling (Shortened Iconographical Falls Efficacy Scale) History of falls (number of falls in the past month)<br>Other: Locomotor assessments<br>* 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: 3 min standing 3 min standing while answering semi-standardized questions 3 min SPTW 3 min SPTW while answering semi-standardized questions (SPTW-Q) 3 min SPTW while verbally describing a VR environment (SPTW-VR1) 6 min SPTW in a VR environment containing freezing of gait provoking elements (SPTW-VR2)<br>Other: Speech assessments<br>* Acoustic analysis (including voice reports and formant analysis), video recording and motor speech profile (including analysis of diadochokinesis, voice, standard syllabic rate, intonation and second formant (F2)). Spontaneous speech production will be assessed by answering semi-standardized questions based on the Aachen Aphasia Test and by describing a VR environment projected on a 180-degree cylindrical screen The Speech Handicap Index (a 15-item self-reported questionnaire)<br>Other: Audiology assessments<br>* Otoscopy Tympanometry Pure tone audiometry Otoacoustic emissions Video Head Impuls Test Cervical Vestibular Evoked Myogenic Potentials Ocular Vestibular Evoked Myogenic Potentials Oculomotor function testing Positional testing Static visual acuity test Dynamic visual acuity test Dizziness Handicap Inventory (a 25-item self-assessment inventory)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Accidental Falls, Risk factor, Gait, Speech, Audiology