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Factors Associated With Falling in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04440033
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Collaborator:
University Ghent
Information provided by (Responsible Party):
University Hospital, Ghent

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: Locomotor assessments Other: Speech assessments Other: Audiology assessments Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Case-control
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Factors Associated With Falling in Parkinson's Disease: a Multidisciplinary Prospective Study
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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

  9. 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

  10. 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.

  11. Otoscopy [ Time Frame: baseline ]
    A otoscopic test to examine the external auditory canal and the tympanic membrane

  12. Tympanometry [ Time Frame: baseline ]
    An auditory test to assess the middle-ear function

  13. Pure tone audiometry [ Time Frame: baseline ]
    An auditory test to assess hearing threshold levels

  14. Otoacoustic Emissions Test [ Time Frame: baseline ]
    An auditory test to measure cochlear outer hair cell function

  15. Video Head Impuls Test [ Time Frame: baseline ]
    A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals

  16. Cervical Vestibular Evoked Myogenic Potential Testing [ Time Frame: baseline ]
    A vestibular function test to assess the saccular and inferior vestibular nerve function

  17. Ocular Vestibular Evoked Myogenic Potential Testing [ Time Frame: baseline ]
    A vestibular function test to assess the utricular and superior vestibular nerve function

  18. Ocular Motor Testing [ Time Frame: baseline ]
    A vestibular function test to evaluate oculomotor function

  19. Dix-Hallpike Test [ Time Frame: baseline ]
    A diagnostic maneuver to identify benign paroxysmal positional vertigo

  20. Roll Test [ Time Frame: baseline ]
    A diagnostic maneuver to identify benign paroxysmal positional vertigo

  21. Static visual acuity [ Time Frame: baseline ]
    Static visual acuity measured using a Snellen chart (static logMAR)

  22. 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)

  23. 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.


Other Outcome Measures:
  1. Age [ Time Frame: baseline ]
    Years since birth

  2. Sex [ Time Frame: baseline ]
    Male or female

  3. Montreal Cognitive Assessment [ Time Frame: baseline ]
    A screening test to assess global cognition (0-30). Higher scores indicate better performance.

  4. 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).

  5. Fall history [ Time Frame: baseline ]
    Number of falls in the past month

  6. 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.

  7. 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.

  8. 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.

  9. Hoehn and Yahr scale [ Time Frame: baseline ]
    A scale to assess disease severity/progression (0-5). Higher scores indicate more severe symptoms.

  10. 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.

  11. Time since diagnosis [ Time Frame: baseline ]
    The number of days since the diagnosis of Parkinson's Disease

  12. Blood pressure [ Time Frame: baseline ]
    The ratio of systolic over diastolic blood pressure (mm Hg)

  13. Medication [ Time Frame: baseline ]
    Number, type and dose (mg) of medication



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440033


Contacts
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Contact: Nina Lefeber, PhD +32 9 332 46 57 Nina.Lefeber@UGent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Katie Bouche, PhD       Katie.Bouche@uzgent.be   
Ghent University Recruiting
Ghent, Belgium, 9000
Contact: Nina Lefeber, PhD       Nina.Lefeber@UGent.be   
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
Investigators
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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
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT04440033    
Other Study ID Numbers: B6702020000044
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
Parkinson's Disease
Accidental Falls
Risk factor
Gait
Speech
Audiology
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases