- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04440033
Factors Associated With Falling in Parkinson's Disease
Factors Associated With Falling in Parkinson's Disease: a Multidisciplinary Prospective Study
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nina Lefeber, PhD
- Phone Number: +32 9 332 46 57
- Email: Nina.Lefeber@UGent.be
Study Locations
-
-
-
Ghent, Belgium, 9000
- Ghent University Hospital
-
Ghent, Belgium, 9000
- Ghent University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Parkinson's Disease group
Patients with stage 3 idiopathic Parkinson's Disease
|
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:
|
Active Comparator: Healthy control group
Age and sex-matched healthy adults
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fall events
Time Frame: baseline to 6 months after baseline
|
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
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 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
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 (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
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 (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
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 (°) 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
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 (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
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 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
Time Frame: 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).
|
baseline during 6 min self-paced treadmill walking in a virtual environment
|
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
|
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
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
|
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
Time Frame: 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.
|
baseline
|
Otoscopy
Time Frame: baseline
|
A otoscopic test to examine the external auditory canal and the tympanic membrane
|
baseline
|
Tympanometry
Time Frame: baseline
|
An auditory test to assess the middle-ear function
|
baseline
|
Pure tone audiometry
Time Frame: baseline
|
An auditory test to assess hearing threshold levels
|
baseline
|
Otoacoustic Emissions Test
Time Frame: baseline
|
An auditory test to measure cochlear outer hair cell function
|
baseline
|
Video Head Impuls Test
Time Frame: baseline
|
A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals
|
baseline
|
Cervical Vestibular Evoked Myogenic Potential Testing
Time Frame: baseline
|
A vestibular function test to assess the saccular and inferior vestibular nerve function
|
baseline
|
Ocular Vestibular Evoked Myogenic Potential Testing
Time Frame: baseline
|
A vestibular function test to assess the utricular and superior vestibular nerve function
|
baseline
|
Ocular Motor Testing
Time Frame: baseline
|
A vestibular function test to evaluate oculomotor function
|
baseline
|
Dix-Hallpike Test
Time Frame: baseline
|
A diagnostic maneuver to identify benign paroxysmal positional vertigo
|
baseline
|
Roll Test
Time Frame: baseline
|
A diagnostic maneuver to identify benign paroxysmal positional vertigo
|
baseline
|
Static visual acuity
Time Frame: baseline
|
Static visual acuity measured using a Snellen chart (static logMAR)
|
baseline
|
Dynamic visual acuity
Time Frame: baseline
|
Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)
|
baseline
|
Dizziness Handicap Inventory
Time Frame: 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.
|
baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: baseline
|
Years since birth
|
baseline
|
Sex
Time Frame: baseline
|
Male or female
|
baseline
|
Montreal Cognitive Assessment
Time Frame: baseline
|
A screening test to assess global cognition (0-30).
Higher scores indicate better performance.
|
baseline
|
Shortened Iconographical Falls Efficacy Scale
Time Frame: 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).
|
baseline
|
Fall history
Time Frame: baseline
|
Number of falls in the past month
|
baseline
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I
Time Frame: baseline
|
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
Time Frame: baseline
|
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
Time Frame: baseline
|
A 6-item rating scale to assess motor complications.
Higher scores indicate a worse outcome.
|
baseline
|
Hoehn and Yahr scale
Time Frame: baseline
|
A scale to assess disease severity/progression (0-5).
Higher scores indicate more severe symptoms.
|
baseline
|
New Freezing of Gait Questionnaire
Time Frame: baseline
|
A 9-item questionnaire to assess freezing of gait severity (0-28).
Higher scores indicate more severe freezing of gait.
|
baseline
|
Time since diagnosis
Time Frame: baseline
|
The number of days since the diagnosis of Parkinson's Disease
|
baseline
|
Blood pressure
Time Frame: baseline
|
The ratio of systolic over diastolic blood pressure (mm Hg)
|
baseline
|
Medication
Time Frame: baseline
|
Number, type and dose (mg) of medication
|
baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-07392
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Baseline assessment of demographic, anthropometric and clinical characteristics
-
Reproductive & Genetic Hospital of CITIC-XiangyaWest China Hospital; Central South UniversityActive, not recruitingInfertility | Assisted Reproductive Technology
-
Procare Health Iberia S.L.CompletedFemale Sexual DysfunctionSpain
-
University Hospital, Strasbourg, FranceCompletedAutism Spectrum DisordersFrance
-
Cairo UniversityUnknownFetal MalnutritionEgypt
-
Hacettepe UniversityCompletedSingle-ventricle | Exercise Capacity | Hemodynamic Instability | Arterial Stiffness | Muscle Oxygenation | Fontan ProcedureTurkey
-
University Hospital, ToulouseNot yet recruiting
-
Hospices Civils de LyonCompletedChemotherapy Effect | G-CHOP Chemotherapy | R-CHOP ChemotherapyFrance
-
Hospital de Clinicas de Porto AlegreUnknownSpinocerebellar Ataxia Type 3 | Machado-Joseph Disease | SCA3 | MJDBrazil
-
Hospices Civils de LyonUnknownMetastatic Cancer | Gastro-enteropancreatic Neuroendocrine Tumor | Health Care CostsFrance
-
University of PalermoCompleted