Contribution of Virtual Reality and Modelling in Falling Risk Assessment in Elderly and Parkinson's Disease Patients
PrévSim
Immersive Virtual Reality Using a Head Mounted Display and Modelling Using Machine Learning Algorithms to Assess Risk of Falling in the Elderly and Patients With Parkinson's Disease.
1 other identifier
interventional
116
1 country
1
Brief Summary
The process of ageing affects at the same time the sensory, cognitive and driving functions. Furthermore, ageing is often accompanied by pathologies increasing the effects of the senescence. An ageing subject will have then more difficulties in maintaining balance control and will have a falling risk with sometimes critical consequences for the quality of life. The risk of fall is estimated by tests at the same time of current life and with scores of sensitivity and specificity which must be improved. In a review including 25 studies (2 314 subjects), show a sensitivity of 32 % and a specificity of 73 % on the test "Timed Up and Go" (TUG) with a threshold at 13.5 seconds. In addition, the fall occurs in a multifactorial context when a subject interacts with his environment. It therefore seems essential to test balance control or falling risk of individuals as close as possible to the situations of daily life. This research, based on the TUG, will aim to assess the neuro-psycho-motor behavior of subjects in situations close to daily life using a Virtual Reality (VR) and Human Metrology platform. The results could ultimately lead to increased sensitivity and specificity in assessing the risk of falling with a TUG performed in VR, compared to the classic TUG, which is commonly used by healthcare professionals and thus allow for earlier or more appropriate management of the subject in preventing the risk of falling. This could allow healthcare professionals to better understand the risk of falling and thus guide medical recommendations and prescribing, particularly in terms of appropriate physical activity programs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedStudy Start
First participant enrolled
April 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedApril 16, 2019
April 1, 2019
1.2 years
January 30, 2019
April 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Timed Up & Go in virtual reality (VR)
Time
Baseline
Secondary Outcomes (13)
Timed Up & Go (non VR condition)
Baseline
Validation of the TUG in VR condition
1 year follow-up
Correlation between TUG and TUG VR times and fall follow-up
1 year follow-up
Kinematics analysis
Baseline
Kinetics analysis
Baseline
- +8 more secondary outcomes
Study Arms (3)
Non falling elderly
EXPERIMENTALFalling elderly
EXPERIMENTALNon falling patients with Parkinson's disease
EXPERIMENTALInterventions
Biomechanical, physiological, psychological and behavioral analyses
Eligibility Criteria
You may qualify if:
- Non-faller elderly
- Male and female
- Age between 65 and 80 years old
- Autonomous
- Reporting no fall in the last 12 months
- Fallers elderly
- Male and female
- Age between 65 and 80 years old
- Autonomous
- Reporting at least 1 fall in the last 12 months
- Non-faller Patients with Parkinson's disease
- Male and female
- Age between 65 and 80 years old
- Autonomous
- Reporting no fall in the last 12 months
- +2 more criteria
You may not qualify if:
- Hearing loss preventing understanding of the instructions and listening to the sound message
- Visual acuity not compatible with the test procedure in virtual reality
- Inability to move without assistance
- Not understanding written and oral French, illiteracy, dementia
- Treatment including psychotropic drugs
- Person in emergency situation,
- Major person subject to a legal protection measure (guardianship, curator, safeguard of justice),
- Major person unable to express his consent,
- Hospitalized person,
- Person deprived of liberty by a judicial or administrative decision, the persons being the object of psychiatric care by virtue of articles L. 3212-1 and L. 3213-1 of the french Code of Public Health,
- Person likely, in the opinion of the investigator, not to be cooperating or respectful of the obligations inherent to participation in the study
- Person with a predisposition to epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Central Hospital, Nancy, Francelead
- OHS - Office d'Hygiène Socialecollaborator
- ONPA - Office Nancéien des Personnes Agéescollaborator
- University of Lorrainecollaborator
Study Sites (1)
University Hospital of Nancy
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2019
First Posted
February 21, 2019
Study Start
April 30, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2022
Last Updated
April 16, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share