Contribution of Virtual Reality and Modelling in Falling Risk Assessment in Elderly and Parkinson's Disease Patients

NCT ID: NCT03848897

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2022-06-30

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.

Conditions

Aging Disorder; Parkinson Disease

Study Design

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

Study Groups

Non falling elderly

Group Type: EXPERIMENTAL

Metrology of motor behavior

Intervention Type: OTHER

Biomechanical, physiological, psychological and behavioral analyses

Falling elderly

Group Type: EXPERIMENTAL

Metrology of motor behavior

Intervention Type: OTHER

Biomechanical, physiological, psychological and behavioral analyses

Non falling patients with Parkinson's disease

Group Type: EXPERIMENTAL

Metrology of motor behavior

Intervention Type: OTHER

Biomechanical, physiological, psychological and behavioral analyses

Interventions

Metrology of motor behavior

Biomechanical, physiological, psychological and behavioral analyses

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

OHS - Office d'Hygiène Sociale

UNKNOWN

Sponsor Role: collaborator

ONPA - Office Nancéien des Personnes Agées

UNKNOWN

Sponsor Role: collaborator

University of Lorraine

OTHER

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Nancy

Vandœuvre-lès-Nancy, , France

Countries

France

Central Contacts

Philippe Perrin, MD PhD Prof

Role: CONTACT

philippe.perrin@univ-lorraine.fr

+33383154650

Facility Contacts

Philippe Perrin, MD PhD Prof

Role: primary

philippe.perrin@univ-lorraine.fr

383154650

Other Identifiers

2018-A02637-48

Identifier Type: -

Identifier Source: org_study_id