Factors Associated with Falling in Parkinson's Disease

NCT ID: NCT04440033

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-12
• Study Completion Date: 2023-12-01

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Parkinson's Disease group

Patients with stage 3 idiopathic Parkinson's Disease

Group Type: EXPERIMENTAL

Baseline assessment of demographic, anthropometric and clinical characteristics

Intervention Type: OTHER

• 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)

Locomotor assessments

Intervention Type: OTHER

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

Intervention Type: OTHER

• 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

Intervention Type: OTHER

• 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)

Healthy control group

Age and sex-matched healthy adults

Group Type: ACTIVE_COMPARATOR

Baseline assessment of demographic, anthropometric and clinical characteristics

Intervention Type: OTHER

• 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

Intervention Type: OTHER

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

Intervention Type: OTHER

• 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

Intervention Type: OTHER

• 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: OTHER

Eligibility Criteria

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

• Age and sex-matched healthy adults

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

• Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)
• Body weight over 120 kilograms
• Pregnancy
• Participation in other ongoing experimental trials

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katie Bouche, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Leen Maes, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Anke Van Bladel, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Nina Lefeber, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Ghent University

Ghent, , Belgium

Countries

Belgium

Other Identifiers

BC-07392

Identifier Type: -

Identifier Source: org_study_id