Contribution of Virtual Reality and Modelling in Falling Risk Assessment in Elderly and Parkinson's Disease Patients (PrévSim)
Primary Purpose
Aging Disorder, Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Metrology of motor behavior
Sponsored by
About this trial
This is an interventional prevention trial for Aging Disorder focused on measuring Virtual reality, Human metrology, Motor behavior, Modeling, Ageing, Parkinson's disease
Eligibility Criteria
Inclusion Criteria:
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
- Dopa-sensitive
- In ON period of treatment of Parkinson's disease
Exclusion Criteria:
- 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
Sites / Locations
- University Hospital of Nancy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Non falling elderly
Falling elderly
Non falling patients with Parkinson's disease
Arm Description
Outcomes
Primary Outcome Measures
Timed Up & Go in virtual reality (VR)
Time
Secondary Outcome Measures
Timed Up & Go (non VR condition)
Time
Validation of the TUG in VR condition
Sensitivity and specificity of the TUG and TUG VR conditions
Correlation between TUG and TUG VR times and fall follow-up
Kinematics analysis
Measurement of full body motion (coordinates on x, y, z axis) in function of the time during the virtual reality tasks
Kinetics analysis
Measurement of plantar pressure evolution (force in Newton) in function of the time during the virtual reality tasks
Physiological analysis 1
Measurement of heart pace evolution (bpm) in function of the time during the virtual reality tasks
Physiological analysis 2
Measurement of breathing evolution (frequence) in function of the time during the virtual reality tasks
Physiological analysis 3
Measurement of galvanic skin response evolution (µSiemens) in function of the time during the virtual reality tasks
Visual attention analysis
Measurement of the gaze focused on virtual objects parameters (number of gazed on each object and time spend focused on the said object)
Psychology analysis 1
Measurement of the fear of falling (Fall Efficacy Scale-International from Tinetti with a score from 16 to 64)
Psychology analysis 2
Measurement of the fear of falling (Activities specific Balance Confidence - Scale from Powell & Myers with a score from 0 to 45)
Psychology analysis 3
Measurement of the coping strategies (Ways of Coping Checklist from Folkman & Lazarus with scores from 1 to 5 for the remembered stress situation subjective evaluation, a score from 10 to 40 for the Problem item, a score from 9 to 36 for the Emotion item and a score from 8 to 32 for the encourgament item).
Automated learning and falling risk estimation
Supervised learning with Support Vector Machine, Decision tree, Linear discriminant.
Using machine learning algorithms is not a measurement but data processing compiling all the data from measurement and comparing them to the number of fall during the year follow up. Machine learning algorithms will learn from these data to classify any new participant into a profile "with a low risk of fall", "with a high risk of fall" or "without a risk of fall".
Full Information
NCT ID
NCT03848897
First Posted
January 30, 2019
Last Updated
April 12, 2019
Sponsor
Central Hospital, Nancy, France
Collaborators
OHS - Office d'Hygiène Sociale, ONPA - Office Nancéien des Personnes Agées, University of Lorraine
1. Study Identification
Unique Protocol Identification Number
NCT03848897
Brief Title
Contribution of Virtual Reality and Modelling in Falling Risk Assessment in Elderly and Parkinson's Disease Patients
Acronym
PrévSim
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2019 (Anticipated)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
OHS - Office d'Hygiène Sociale, ONPA - Office Nancéien des Personnes Agées, University of Lorraine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging Disorder, Parkinson Disease
Keywords
Virtual reality, Human metrology, Motor behavior, Modeling, Ageing, Parkinson's disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non falling elderly
Arm Type
Experimental
Arm Title
Falling elderly
Arm Type
Experimental
Arm Title
Non falling patients with Parkinson's disease
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Metrology of motor behavior
Intervention Description
Biomechanical, physiological, psychological and behavioral analyses
Primary Outcome Measure Information:
Title
Timed Up & Go in virtual reality (VR)
Description
Time
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Timed Up & Go (non VR condition)
Description
Time
Time Frame
Baseline
Title
Validation of the TUG in VR condition
Description
Sensitivity and specificity of the TUG and TUG VR conditions
Time Frame
1 year follow-up
Title
Correlation between TUG and TUG VR times and fall follow-up
Time Frame
1 year follow-up
Title
Kinematics analysis
Description
Measurement of full body motion (coordinates on x, y, z axis) in function of the time during the virtual reality tasks
Time Frame
Baseline
Title
Kinetics analysis
Description
Measurement of plantar pressure evolution (force in Newton) in function of the time during the virtual reality tasks
Time Frame
Baseline
Title
Physiological analysis 1
Description
Measurement of heart pace evolution (bpm) in function of the time during the virtual reality tasks
Time Frame
Baseline
Title
Physiological analysis 2
Description
Measurement of breathing evolution (frequence) in function of the time during the virtual reality tasks
Time Frame
Baseline
Title
Physiological analysis 3
Description
Measurement of galvanic skin response evolution (µSiemens) in function of the time during the virtual reality tasks
Time Frame
Baseline
Title
Visual attention analysis
Description
Measurement of the gaze focused on virtual objects parameters (number of gazed on each object and time spend focused on the said object)
Time Frame
Baseline
Title
Psychology analysis 1
Description
Measurement of the fear of falling (Fall Efficacy Scale-International from Tinetti with a score from 16 to 64)
Time Frame
Baseline
Title
Psychology analysis 2
Description
Measurement of the fear of falling (Activities specific Balance Confidence - Scale from Powell & Myers with a score from 0 to 45)
Time Frame
Baseline
Title
Psychology analysis 3
Description
Measurement of the coping strategies (Ways of Coping Checklist from Folkman & Lazarus with scores from 1 to 5 for the remembered stress situation subjective evaluation, a score from 10 to 40 for the Problem item, a score from 9 to 36 for the Emotion item and a score from 8 to 32 for the encourgament item).
Time Frame
Baseline
Title
Automated learning and falling risk estimation
Description
Supervised learning with Support Vector Machine, Decision tree, Linear discriminant.
Using machine learning algorithms is not a measurement but data processing compiling all the data from measurement and comparing them to the number of fall during the year follow up. Machine learning algorithms will learn from these data to classify any new participant into a profile "with a low risk of fall", "with a high risk of fall" or "without a risk of fall".
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Dopa-sensitive
In ON period of treatment of Parkinson's disease
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Perrin, MD PhD Prof
Phone
+33383154650
Email
philippe.perrin@univ-lorraine.fr
Facility Information:
Facility Name
University Hospital of Nancy
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Perrin, MD PhD Prof
Phone
383154650
Email
philippe.perrin@univ-lorraine.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Contribution of Virtual Reality and Modelling in Falling Risk Assessment in Elderly and Parkinson's Disease Patients
We'll reach out to this number within 24 hrs