Parkinson DiseaseNCT04440033
Factors Associated with Falling in Parkinson's Disease
A study testing Baseline assessment of demographic, anthropometric and clinical characteristics, Locomotor assessments and Speech assessments in people with Parkinson Disease, run by University Hospital, Ghent at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Baseline assessment of demographic, anthropometric and clinical characteristics, Locomotor assessments and Speech assessments
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesBelgium
- Study dates
- 12 Oct 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Age and sex-matched healthy adults
Who cannot join
- 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)
Show all 19Show fewer
- 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
- Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)
- Body weight over 120 kilograms
- Pregnancy
- Participation in other ongoing experimental trials
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ghent University Hospital
Ghent, 9000
Ghent University
Ghent, 9000
About this study
Official title: Factors Associated with Falling in Parkinson's Disease: a Multidisciplinary Prospective Study
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.
- Conditions
- Parkinson Disease
- Being tested
- Baseline assessment of demographic, anthropometric and clinical characteristics, Locomotor assessments, Speech assessments, Audiology assessments
- Keywords
- Parkinson's Disease, Accidental Falls, Risk factor, Gait, Speech, Audiology
- Medical subject headings
- Parkinson Disease, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline assessment of demographic, anthropometric and clinical characteristicsOther
- 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)
Baseline assessment of demographic, anthropometric and clinical characteristicsOther
- 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)
Locomotor assessmentsOther
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)
Speech assessmentsOther
- 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)
Audiology assessmentsOther
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease group | Experimental | Patients with stage 3 idiopathic Parkinson's Disease Receives: Other: Baseline assessment of demographic, anthropometric and clinical characteristics; Other: Locomotor assessments; Other: Speech assessments; Other: Audiology assessments |
| Healthy control group | Active comparator | Age and sex-matched healthy adults Receives: Other: Baseline assessment of demographic, anthropometric and clinical characteristics; Other: Locomotor assessments; Other: Speech assessments; Other: Audiology assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall events
Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.
Measured: baseline to 6 months after baseline
Secondary outcomes (23)
Walking speed
Walking speed (meters/second) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: baseline
Otoscopy
A otoscopic test to examine the external auditory canal and the tympanic membrane
Measured: baseline
Tympanometry
An auditory test to assess the middle-ear function
Measured: baseline
Pure tone audiometry
An auditory test to assess hearing threshold levels
Measured: baseline
Otoacoustic Emissions Test
An auditory test to measure cochlear outer hair cell function
Measured: baseline
Video Head Impuls Test
A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals
Measured: baseline
Cervical Vestibular Evoked Myogenic Potential Testing
A vestibular function test to assess the saccular and inferior vestibular nerve function
Measured: baseline
Ocular Vestibular Evoked Myogenic Potential Testing
A vestibular function test to assess the utricular and superior vestibular nerve function
Measured: baseline
Ocular Motor Testing
A vestibular function test to evaluate oculomotor function
Measured: baseline
Dix-Hallpike Test
A diagnostic maneuver to identify benign paroxysmal positional vertigo
Measured: baseline
Roll Test
A diagnostic maneuver to identify benign paroxysmal positional vertigo
Measured: baseline
Static visual acuity
Static visual acuity measured using a Snellen chart (static logMAR)
Measured: baseline
Dynamic visual acuity
Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start12 Oct 2020
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Case-control
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Katie Bouche, PhD, Principal investigator, University Hospital, GhentLeen Maes, PhD, Principal investigator, University GhentAnke Van Bladel, PhD, Principal investigator, University GhentNina Lefeber, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440033
- Sponsor's protocol ID
- BC-07392
- Status last verified
- Sep 2024
- First submitted
- 3 Jun 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated with Falling in Parkinson's Disease: a Multidisciplinary Prospective Study
- ClinicalTrials.gov ID
- NCT04440033
- Acronym / sponsor ID
- BC-07392
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Accidental Falls, Risk factor, Gait, Speech, Audiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case-control
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease group | Experimental | Other: Baseline assessment of demographic, anthropometric and clinical characteristics, Other: Locomotor assessments, Other: Speech assessments, Other: Audiology assessmentsPatients with stage 3 idiopathic Parkinson's Disease |
| Healthy control group | Active comparator | Other: Baseline assessment of demographic, anthropometric and clinical characteristics, Other: Locomotor assessments, Other: Speech assessments, Other: Audiology assessmentsAge and sex-matched healthy adults |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Parkinson's Disease group |
| 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 | Healthy control group |
| Locomotor assessmentsFirst, 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 | Healthy control group, Parkinson's Disease group |
| 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 | Healthy control group, Parkinson's Disease group |
| 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) | Other | Healthy control group, Parkinson's Disease group |
Primary outcome
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.
23 secondary outcomes
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 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
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
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 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 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
Freezing of gait
Time frame: 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
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
Time frame: baseline
Otoscopy
Time frame: baseline
Tympanometry
Time frame: baseline
Pure tone audiometry
Time frame: baseline
Otoacoustic Emissions Test
Time frame: baseline
Video Head Impuls Test
Time frame: baseline
Cervical Vestibular Evoked Myogenic Potential Testing
Time frame: baseline
Ocular Vestibular Evoked Myogenic Potential Testing
Time frame: baseline
Ocular Motor Testing
Time frame: baseline
Dix-Hallpike Test
Time frame: baseline
Roll Test
Time frame: baseline
Static visual acuity
Time frame: baseline
Dynamic visual acuity
Time frame: baseline
Dizziness Handicap Inventory
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Bouche, PhD principal investigator
University Hospital, Ghent
Leen Maes, PhD principal investigator
University Ghent
Anke Van Bladel, PhD principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline assessment of demographic, anthropometric and clinical characteristics, Locomotor assessments and Speech assessments in people with Parkinson Disease, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall events (time frame: baseline to 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.