Factors Associated with Falling in Parkinson's Disease

NCT04440033 | Completed

• 1 other identifier: BC-07392
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Keywords

Parkinson's Disease; Accidental Falls; Risk factor; Gait; Speech; Audiology

Outcome Measures

Primary Outcomes (1)

• Fall events

  Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.

  baseline to 6 months after baseline

Secondary Outcomes (23)

• 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 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

• 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

• 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 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

Other Outcomes (13)

• Age

  baseline

• Sex

  baseline

• Montreal Cognitive Assessment

  baseline

Study Arms (2)

Parkinson's Disease group

EXPERIMENTAL

Patients with stage 3 idiopathic Parkinson's Disease

Other: Baseline assessment of demographic, anthropometric and clinical characteristics; Other: Locomotor assessments; Other: Speech assessments; Other: Audiology assessments

Healthy control group

ACTIVE COMPARATOR

Age and sex-matched healthy adults

Other: Baseline assessment of demographic, anthropometric and clinical characteristics; Other: Locomotor assessments; Other: Speech assessments; Other: Audiology assessments

Interventions

Baseline assessment of demographic, anthropometric and clinical characteristics 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)

Parkinson's Disease group

Locomotor assessments 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)

Healthy control group; Parkinson's Disease group

Speech assessments 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)

Healthy control group; Parkinson's Disease group

Audiology assessments 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; Parkinson's Disease group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (2)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Parkinson Disease; Speech

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Verbal Behavior; Communication; Behavior

Study Officials

• Katie Bouche, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Leen Maes, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Anke Van Bladel, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Nina Lefeber, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case-control

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 19, 2020
• Study Start: October 12, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (2)