An interventional study of Baseline assessment of demographic, anthropometric and clinical characteristics and Baseline assessment of demographic, anthropometric and clinical characteristics in Parkinson Disease, sponsored by University Hospital, Ghent. Completed at 2 sites in Belgium. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Screening
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.
4,585 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Hospital, Ghent is the lead sponsor of 685 studies on the registry; 158 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Parkinson's Disease group
Inclusion criteria:
Exclusion criteria:
Healthy control group
Inclusion criteria:
Exclusion criteria:
Patients with stage 3 idiopathic Parkinson's Disease
Other: Baseline assessment of demographic, anthropometric and clinical characteristics · Other: Locomotor assessments · Other: Speech assessments · Other: Audiology assessments
Age and sex-matched healthy adults
Other: Baseline assessment of demographic, anthropometric and clinical characteristics · Other: Locomotor assessments · Other: Speech assessments · Other: Audiology assessments
* 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)
* 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)
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)
* 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)
* 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)
Fall events
Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.
Time frame: baseline to 6 months after baseline
Walking speed
Walking speed (meters/second) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: baseline
Otoscopy
A otoscopic test to examine the external auditory canal and the tympanic membrane
Time frame: baseline
Tympanometry
An auditory test to assess the middle-ear function
Time frame: baseline
Pure tone audiometry
An auditory test to assess hearing threshold levels
Time frame: baseline
Otoacoustic Emissions Test
An auditory test to measure cochlear outer hair cell function
Time frame: baseline
Video Head Impuls Test
A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals
Time frame: baseline
Cervical Vestibular Evoked Myogenic Potential Testing
A vestibular function test to assess the saccular and inferior vestibular nerve function
Time frame: baseline
Ocular Vestibular Evoked Myogenic Potential Testing
A vestibular function test to assess the utricular and superior vestibular nerve function
Time frame: baseline
Ocular Motor Testing
A vestibular function test to evaluate oculomotor function
Time frame: baseline
Dix-Hallpike Test
A diagnostic maneuver to identify benign paroxysmal positional vertigo
Time frame: baseline
Roll Test
A diagnostic maneuver to identify benign paroxysmal positional vertigo
Time frame: baseline
Static visual acuity
Static visual acuity measured using a Snellen chart (static logMAR)
Time frame: baseline
Dynamic visual acuity
Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)
Time frame: 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.
Time frame: baseline
Age
Years since birth
Time frame: baseline
Sex
Male or female
Time frame: baseline
Montreal Cognitive Assessment
A screening test to assess global cognition (0-30). Higher scores indicate better performance.
Time frame: 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).
Time frame: baseline
Fall history
Number of falls in the past month
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline
Hoehn and Yahr scale
A scale to assess disease severity/progression (0-5). Higher scores indicate more severe symptoms.
Time frame: 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.
Time frame: baseline
Time since diagnosis
The number of days since the diagnosis of Parkinson's Disease
Time frame: baseline
Blood pressure
The ratio of systolic over diastolic blood pressure (mm Hg)
Time frame: baseline
Medication
Number, type and dose (mg) of medication
Time frame: baseline
Ran from Oct 2020 to primary completion in Dec 2023, 37 months.
Of 1,296 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 37 months is above that.
Counting every sponsor, half of 1,369 studies reached it within 24 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.