Clinical trial NCT04440033: Factors Associated with Falling in Parkinson's Disease
Official title: Factors Associated with Falling in Parkinson's Disease: a Multidisciplinary Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Accidental Falls
Risk factor
Gait
Speech
Audiology
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2020-06-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case-control
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fall events
timeFrame: baseline to 6 months after baseline
Secondary outcomes:
measure: Walking speed
timeFrame: 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
measure: Walking cadence
timeFrame: 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
measure: Step length
timeFrame: 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
measure: Hip, knee and ankle joint angle during walking
timeFrame: 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
measure: Hip, knee and ankle joint moment during walking
timeFrame: 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
measure: Hip, knee and ankle joint power during walking
timeFrame: 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
measure: Freezing of gait
timeFrame: baseline during 6 min self-paced treadmill walking in a virtual environment
measure: Spontaneous speech production
timeFrame: 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
measure: Spontaneous speech production
timeFrame: 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
measure: Speech Handicap Index
timeFrame: baseline
measure: Otoscopy
timeFrame: baseline
measure: Tympanometry
timeFrame: baseline
measure: Pure tone audiometry
timeFrame: baseline
measure: Otoacoustic Emissions Test
timeFrame: baseline
measure: Video Head Impuls Test
timeFrame: baseline
measure: Cervical Vestibular Evoked Myogenic Potential Testing
timeFrame: baseline
measure: Ocular Vestibular Evoked Myogenic Potential Testing
timeFrame: baseline
measure: Ocular Motor Testing
timeFrame: baseline
measure: Dix-Hallpike Test
timeFrame: baseline
measure: Roll Test
timeFrame: baseline
measure: Static visual acuity
timeFrame: baseline
measure: Dynamic visual acuity
timeFrame: baseline
measure: Dizziness Handicap Inventory
timeFrame: baseline
Other outcomes:
measure: Age
timeFrame: baseline
measure: Sex
timeFrame: baseline
measure: Montreal Cognitive Assessment
timeFrame: baseline
measure: Shortened Iconographical Falls Efficacy Scale
timeFrame: baseline
measure: Fall history
timeFrame: baseline
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I
timeFrame: baseline
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
timeFrame: baseline
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV
timeFrame: baseline
measure: Hoehn and Yahr scale
timeFrame: baseline
measure: New Freezing of Gait Questionnaire
timeFrame: baseline
measure: Time since diagnosis
timeFrame: baseline
measure: Blood pressure
timeFrame: baseline
measure: Medication
timeFrame: baseline
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Hospital, Ghent
name: Katie Bouche, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Leen Maes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Anke Van Bladel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Nina Lefeber, PhD
role: PRINCIPAL_INVESTIGATOR
References: