Factors Associated With Falling in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440033
• Other study ID #: BC-07392
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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)
• 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)
• 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)
• 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)
• 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)

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Years since birth	baseline
Other	Sex	Male or female	baseline
Other	Montreal Cognitive Assessment	A screening test to assess global cognition (0-30). Higher scores indicate better performance.	baseline
Other	Shortened Iconographical Falls Efficacy Scale	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).	baseline
Other	Fall history	Number of falls in the past month	baseline
Other	Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I	A 13-item rating scale to assess non-motor experiences of daily living (0-52). Higher scores indicate a worse outcome.	baseline
Other	Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III	An 18-item motor examination to assess motor symptoms (0-132). Higher scores indicate a worse outcome.	baseline
Other	Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV	A 6-item rating scale to assess motor complications. Higher scores indicate a worse outcome.	baseline
Other	Hoehn and Yahr scale	A scale to assess disease severity/progression (0-5). Higher scores indicate more severe symptoms.	baseline
Other	New Freezing of Gait Questionnaire	A 9-item questionnaire to assess freezing of gait severity (0-28). Higher scores indicate more severe freezing of gait.	baseline
Other	Time since diagnosis	The number of days since the diagnosis of Parkinson's Disease	baseline
Other	Blood pressure	The ratio of systolic over diastolic blood pressure (mm Hg)	baseline
Other	Medication	Number, type and dose (mg) of medication	baseline
Primary	Fall events	Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.	baseline to 6 months after baseline
Secondary	Walking speed	Walking speed (meters/second) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).	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
Secondary	Walking cadence	Walking cadence (steps/minute) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).	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
Secondary	Step length	Step length (meters) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).	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
Secondary	Hip, knee and ankle joint angle during walking	Hip, knee and ankle joint angle during walking (°) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).	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
Secondary	Hip, knee and ankle joint moment during walking	Hip, knee and ankle joint moment during walking (Nm/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).	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
Secondary	Hip, knee and ankle joint power during walking	Hip, knee and ankle joint moment during power (W/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).	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
Secondary	Freezing of gait	Number of freezing of gait events measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).	baseline during 6 min self-paced treadmill walking in a virtual environment
Secondary	Spontaneous speech production	Audio recordings analyzed using PRAAT software to assess 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
Secondary	Spontaneous speech production	Audio recordings analyzed using Motor Speech Profile software to assess 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
Secondary	Speech Handicap Index	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.	baseline
Secondary	Otoscopy	A otoscopic test to examine the external auditory canal and the tympanic membrane	baseline
Secondary	Tympanometry	An auditory test to assess the middle-ear function	baseline
Secondary	Pure tone audiometry	An auditory test to assess hearing threshold levels	baseline
Secondary	Otoacoustic Emissions Test	An auditory test to measure cochlear outer hair cell function	baseline
Secondary	Video Head Impuls Test	A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals	baseline
Secondary	Cervical Vestibular Evoked Myogenic Potential Testing	A vestibular function test to assess the saccular and inferior vestibular nerve function	baseline
Secondary	Ocular Vestibular Evoked Myogenic Potential Testing	A vestibular function test to assess the utricular and superior vestibular nerve function	baseline
Secondary	Ocular Motor Testing	A vestibular function test to evaluate oculomotor function	baseline
Secondary	Dix-Hallpike Test	A diagnostic maneuver to identify benign paroxysmal positional vertigo	baseline
Secondary	Roll Test	A diagnostic maneuver to identify benign paroxysmal positional vertigo	baseline
Secondary	Static visual acuity	Static visual acuity measured using a Snellen chart (static logMAR)	baseline
Secondary	Dynamic visual acuity	Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)	baseline
Secondary	Dizziness Handicap Inventory	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.	baseline