Factors Associated with Falling in Parkinson's Disease

NCT04440033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

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

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)

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER
  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Katie Bouche, PhD · University Hospital, Ghent

  • Leen Maes, PhD · University Ghent

  • Anke Van Bladel, PhD · University Ghent

  • Nina Lefeber, PhD · University Ghent

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04440033 on ClinicalTrials.gov