Back to resultsFactors Associated With Falling in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Baseline assessment of demographic, anthropometric and clinical characteristics
Baseline assessment of demographic, anthropometric and clinical characteristics
Locomotor assessments
Speech assessments
Audiology assessments
Sponsored by
About this trial
This is an interventional screening trial for Parkinson Disease focused on measuring Parkinson's Disease, Accidental Falls, Risk factor, Gait, Speech, Audiology
Eligibility Criteria
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
Sites / Locations
- Ghent University HospitalRecruiting
- Ghent UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parkinson's Disease group
Healthy control group
Arm Description
Patients with stage 3 idiopathic Parkinson's Disease
Age and sex-matched healthy adults
Outcomes
Primary Outcome Measures
Fall events
Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.
Secondary Outcome Measures
Walking speed
Walking speed (meters/second) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Walking cadence
Walking cadence (steps/minute) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Step length
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
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
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
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
Number of freezing of gait events measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Spontaneous speech production
Audio recordings analyzed using PRAAT software to assess spontaneous speech production
Spontaneous speech production
Audio recordings analyzed using Motor Speech Profile software to assess spontaneous speech production
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.
Otoscopy
A otoscopic test to examine the external auditory canal and the tympanic membrane
Tympanometry
An auditory test to assess the middle-ear function
Pure tone audiometry
An auditory test to assess hearing threshold levels
Otoacoustic Emissions Test
An auditory test to measure cochlear outer hair cell function
Video Head Impuls Test
A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals
Cervical Vestibular Evoked Myogenic Potential Testing
A vestibular function test to assess the saccular and inferior vestibular nerve function
Ocular Vestibular Evoked Myogenic Potential Testing
A vestibular function test to assess the utricular and superior vestibular nerve function
Ocular Motor Testing
A vestibular function test to evaluate oculomotor function
Dix-Hallpike Test
A diagnostic maneuver to identify benign paroxysmal positional vertigo
Roll Test
A diagnostic maneuver to identify benign paroxysmal positional vertigo
Static visual acuity
Static visual acuity measured using a Snellen chart (static logMAR)
Dynamic visual acuity
Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)
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.
Full Information
NCT ID
NCT04440033
First Posted
June 3, 2020
Last Updated
December 20, 2022
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
1. Study Identification
Unique Protocol Identification Number
NCT04440033
Brief Title
Factors Associated With Falling in Parkinson's Disease
Official Title
Factors Associated With Falling in Parkinson's Disease: a Multidisciplinary Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, Accidental Falls, Risk factor, Gait, Speech, Audiology
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case-control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parkinson's Disease group
Arm Type
Experimental
Arm Description
Patients with stage 3 idiopathic Parkinson's Disease
Arm Title
Healthy control group
Arm Type
Active Comparator
Arm Description
Age and sex-matched healthy adults
Intervention Type
Other
Intervention Name(s)
Baseline assessment of demographic, anthropometric and clinical characteristics
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Baseline assessment of demographic, anthropometric and clinical characteristics
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Locomotor assessments
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Speech assessments
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Audiology assessments
Intervention Description
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)
Primary Outcome Measure Information:
Title
Fall events
Description
Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.
Time Frame
baseline to 6 months after baseline
Secondary Outcome Measure Information:
Title
Walking speed
Description
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
Title
Walking cadence
Description
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
Title
Step length
Description
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
Title
Hip, knee and ankle joint angle during walking
Description
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
Title
Hip, knee and ankle joint moment during walking
Description
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
Title
Hip, knee and ankle joint power during walking
Description
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
Title
Freezing of gait
Description
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
Title
Spontaneous speech production
Description
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
Title
Spontaneous speech production
Description
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
Title
Speech Handicap Index
Description
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
Title
Otoscopy
Description
A otoscopic test to examine the external auditory canal and the tympanic membrane
Time Frame
baseline
Title
Tympanometry
Description
An auditory test to assess the middle-ear function
Time Frame
baseline
Title
Pure tone audiometry
Description
An auditory test to assess hearing threshold levels
Time Frame
baseline
Title
Otoacoustic Emissions Test
Description
An auditory test to measure cochlear outer hair cell function
Time Frame
baseline
Title
Video Head Impuls Test
Description
A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals
Time Frame
baseline
Title
Cervical Vestibular Evoked Myogenic Potential Testing
Description
A vestibular function test to assess the saccular and inferior vestibular nerve function
Time Frame
baseline
Title
Ocular Vestibular Evoked Myogenic Potential Testing
Description
A vestibular function test to assess the utricular and superior vestibular nerve function
Time Frame
baseline
Title
Ocular Motor Testing
Description
A vestibular function test to evaluate oculomotor function
Time Frame
baseline
Title
Dix-Hallpike Test
Description
A diagnostic maneuver to identify benign paroxysmal positional vertigo
Time Frame
baseline
Title
Roll Test
Description
A diagnostic maneuver to identify benign paroxysmal positional vertigo
Time Frame
baseline
Title
Static visual acuity
Description
Static visual acuity measured using a Snellen chart (static logMAR)
Time Frame
baseline
Title
Dynamic visual acuity
Description
Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)
Time Frame
baseline
Title
Dizziness Handicap Inventory
Description
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
Other Pre-specified Outcome Measures:
Title
Age
Description
Years since birth
Time Frame
baseline
Title
Sex
Description
Male or female
Time Frame
baseline
Title
Montreal Cognitive Assessment
Description
A screening test to assess global cognition (0-30). Higher scores indicate better performance.
Time Frame
baseline
Title
Shortened Iconographical Falls Efficacy Scale
Description
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
Title
Fall history
Description
Number of falls in the past month
Time Frame
baseline
Title
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I
Description
A 13-item rating scale to assess non-motor experiences of daily living (0-52). Higher scores indicate a worse outcome.
Time Frame
baseline
Title
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
Description
An 18-item motor examination to assess motor symptoms (0-132). Higher scores indicate a worse outcome.
Time Frame
baseline
Title
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV
Description
A 6-item rating scale to assess motor complications. Higher scores indicate a worse outcome.
Time Frame
baseline
Title
Hoehn and Yahr scale
Description
A scale to assess disease severity/progression (0-5). Higher scores indicate more severe symptoms.
Time Frame
baseline
Title
New Freezing of Gait Questionnaire
Description
A 9-item questionnaire to assess freezing of gait severity (0-28). Higher scores indicate more severe freezing of gait.
Time Frame
baseline
Title
Time since diagnosis
Description
The number of days since the diagnosis of Parkinson's Disease
Time Frame
baseline
Title
Blood pressure
Description
The ratio of systolic over diastolic blood pressure (mm Hg)
Time Frame
baseline
Title
Medication
Description
Number, type and dose (mg) of medication
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Lefeber, PhD
Phone
+32 9 332 46 57
Email
Nina.Lefeber@UGent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie Bouche, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leen Maes, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anke Van Bladel, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nina Lefeber, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Bouche, PhD
Email
Katie.Bouche@uzgent.be
Facility Name
Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Lefeber, PhD
Email
Nina.Lefeber@UGent.be
12. IPD Sharing Statement
Learn more about this trial
Factors Associated With Falling in Parkinson's Disease
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