Factors Associated With Falling in Parkinson's Disease

Sponsor

University Hospital, Ghent (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04440033

Collaborator

University Ghent (Other)

144

Enrollment

Locations

Arms

14.7

Anticipated Duration (Months)

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Case-controlCase-control

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Oct 12, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Parkinson's Disease group Patients with stage 3 idiopathic Parkinson's Disease	Other: Baseline assessment of demographic, anthropometric and clinical characteristics 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) Other: Locomotor assessments 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) Other: Speech assessments 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) Other: Audiology assessments 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)
Active Comparator: Healthy control group Age and sex-matched healthy adults	Other: Baseline assessment of demographic, anthropometric and clinical characteristics 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) Other: Locomotor assessments 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) Other: Speech assessments 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) Other: Audiology assessments 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)

Arm

Intervention/Treatment

Experimental: Parkinson's Disease group

Patients with stage 3 idiopathic Parkinson's Disease

Other: Baseline assessment of demographic, anthropometric and clinical characteristics

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)

Other: Locomotor assessments

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)

Other: Speech assessments

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)

Other: Audiology assessments

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)

Active Comparator: Healthy control group

Age and sex-matched healthy adults

Other: Baseline assessment of demographic, anthropometric and clinical characteristics

Other: Locomotor assessments

Other: Speech assessments

Other: Audiology assessments

Outcome Measures

Primary Outcome Measures

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

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).
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).
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).
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).
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 PRAAT software to assess spontaneous speech production
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.
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
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
Video Head Impuls Test [baseline]
A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals
Cervical Vestibular Evoked Myogenic Potential Testing [baseline]
A vestibular function test to assess the saccular and inferior vestibular nerve function
Ocular Vestibular Evoked Myogenic Potential Testing [baseline]
A vestibular function test to assess the utricular and superior vestibular nerve function
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
Roll Test [baseline]
A diagnostic maneuver to identify benign paroxysmal positional vertigo
Static visual acuity [baseline]
Static visual acuity measured using a Snellen chart (static logMAR)
Dynamic visual acuity [baseline]
Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)
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.

Other Outcome Measures

Age [baseline]
Years since birth
Sex [baseline]
Male or female
Montreal Cognitive Assessment [baseline]
A screening test to assess global cognition (0-30). Higher scores indicate better performance.
Shortened Iconographical Falls Efficacy Scale [baseline]
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).
Fall history [baseline]
Number of falls in the past month
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I [baseline]
A 13-item rating scale to assess non-motor experiences of daily living (0-52). Higher scores indicate a worse outcome.
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III [baseline]
An 18-item motor examination to assess motor symptoms (0-132). Higher scores indicate a worse outcome.
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV [baseline]
A 6-item rating scale to assess motor complications. Higher scores indicate a worse outcome.
Hoehn and Yahr scale [baseline]
A scale to assess disease severity/progression (0-5). Higher scores indicate more severe symptoms.
New Freezing of Gait Questionnaire [baseline]
A 9-item questionnaire to assess freezing of gait severity (0-28). Higher scores indicate more severe freezing of gait.
Time since diagnosis [baseline]
The number of days since the diagnosis of Parkinson's Disease
Blood pressure [baseline]
The ratio of systolic over diastolic blood pressure (mm Hg)
Medication [baseline]
Number, type and dose (mg) of medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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