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Completed

NCT Number: NCT04440033

Factors Associated with Falling in Parkinson's Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Communication Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Speech Synucleinopathies Verbal Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline assessment of demographic, anthropometric and clinical characteristics

Other
  • 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)

Locomotor assessments

Other

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 assessments

Other
  • 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 assessments

Other
  • 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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

Factors Associated with Falling in Parkinson's Disease: a Multidisciplinary Prospective Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 19, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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