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Clinical Trials/NCT04440033
NCT04440033CompletedNot Applicable

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

University Hospital, Ghent4 sites in 1 country10 target enrollmentStarted: October 12, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
4
Primary Endpoint
Fall events
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Otoacoustic Emissions Test(baseline)
  • Walking cadence(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(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)
  • Otoscopy(baseline)
  • Tympanometry(baseline)
  • Walking speed(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(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(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(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(baseline during 6 min self-paced treadmill walking in a virtual environment)
  • Pure tone audiometry(baseline)
  • Speech Handicap Index(baseline)
  • Video Head Impuls Test(baseline)
  • Ocular Motor Testing(baseline)
  • Dix-Hallpike Test(baseline)
  • Dizziness Handicap Inventory(baseline)
  • Static visual acuity(baseline)
  • Ocular Vestibular Evoked Myogenic Potential Testing(baseline)
  • Dynamic visual acuity(baseline)
  • Cervical Vestibular Evoked Myogenic Potential Testing(baseline)
  • Roll Test(baseline)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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