NCT04440033

Factors Associated with Falling in Parkinson's Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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)
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)
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)
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)
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)

Timeline

• Start date: 2020-10-12
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-06-19
• Last updated: 2024-09-19

Locations

2 sites across 1 country: Belgium