Factors Associated With Falling in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Baseline assessment of demographic, anthropometric and clinical characteristics; Other: Locomotor assessments; Other: Speech assessments; Other: Audiology assessments

• Registration Number: NCT04440033
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Study Start: 2020-10-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy control group	Baseline assessment of demographic, anthropometric and clinical characteristics	Age and sex-matched healthy adults
Parkinson's Disease group	Speech assessments	Patients with stage 3 idiopathic Parkinson's Disease
Parkinson's Disease group	Baseline assessment of demographic, anthropometric and clinical characteristics	Patients with stage 3 idiopathic Parkinson's Disease
Healthy control group	Audiology assessments	Age and sex-matched healthy adults
Parkinson's Disease group	Audiology assessments	Patients with stage 3 idiopathic Parkinson's Disease
Healthy control group	Speech assessments	Age and sex-matched healthy adults
Parkinson's Disease group	Locomotor assessments	Patients with stage 3 idiopathic Parkinson's Disease
Healthy control group	Locomotor assessments	Age and sex-matched healthy adults

Primary Outcome Measures

Name	Time	Method
Fall events	baseline to 6 months after baseline	Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.

Secondary Outcome Measures

Name	Time	Method
Otoacoustic Emissions Test	baseline	An auditory test to measure cochlear outer hair cell function
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	Walking cadence (steps/minute) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
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	Step length (meters) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Otoscopy	baseline	A otoscopic test to examine the external auditory canal and the tympanic membrane
Tympanometry	baseline	An auditory test to assess the middle-ear function
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	Walking speed (meters/second) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
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 angle during walking (°) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
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 moment during walking (Nm/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
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	Hip, knee and ankle joint moment during power (W/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
Freezing of gait	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).
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	Audio recordings analyzed using Motor Speech Profile software to assess spontaneous speech production
Pure tone audiometry	baseline	An auditory test to assess hearing threshold levels
Speech Handicap Index	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.
Video Head Impuls Test	baseline	A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals
Ocular Motor Testing	baseline	A vestibular function test to evaluate oculomotor function
Dix-Hallpike Test	baseline	A diagnostic maneuver to identify benign paroxysmal positional vertigo
Dizziness Handicap Inventory	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.
Static visual acuity	baseline	Static visual acuity measured using a Snellen chart (static logMAR)
Ocular Vestibular Evoked Myogenic Potential Testing	baseline	A vestibular function test to assess the utricular and superior vestibular nerve function
Dynamic visual acuity	baseline	Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)
Cervical Vestibular Evoked Myogenic Potential Testing	baseline	A vestibular function test to assess the saccular and inferior vestibular nerve function
Roll Test	baseline	A diagnostic maneuver to identify benign paroxysmal positional vertigo

Trial Locations

Locations (2)

Ghent University Hospital; 🇧🇪 Ghent, Belgium

Ghent University; 🇧🇪 Ghent, Belgium