Gait Analysis by Induced Disorientation in a VR Environment

Sponsor
University Medical Center Rostock (Other)
Overall Status
Unknown status
CT.gov ID
NCT04134806
Collaborator
University of Rostock (Other), German Center for Neurodegenerative Diseases (DZNE) (Other)
80
1
34
2.4

Study Details

Study Description

Brief Summary

The aim of the study is to investigate whether the effect of disorientation on physical motion and gait among dementia patients, can be reliably measured in a laboratory environment, by means of a virtual reality (VR) experimental setup.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Challenges in wayfinding and orientation are early symptoms of MCI and dementia. These deficits decrease mobility which again leads to further cognitive decline. In a field study, we developed a pattern recognition model of disorientated behaviour based on accelerometric data. However, it is questionable if phases of disorientation also affect gait parameters. Furthermore, there is growing evidence that impaired cognitive functioning is associated with changes in gait performance, e.g. gait variability, measured in dual-task walking conditions. Increases in heart rate and skin conductance have also been reported during instances of disorientation.

    Hence, We implemented a 3D environment of a familiar city centre in the GRAIL, which combines a fully instrumented treadmill with a synchronized VR environment. We record gait parameters through the motion capture system, and accelerometric and physiological data using wearable sensors (movisens), for comparability with the SiNDeM field study. Young and old healthy adults will participate in the first phase of the study, while Mild dementia or MCI patients will participate in the later phases. Phases of disorientation will be induced by changing the virtual environment.We aim to assess gait, accelerometric and physiological parameters during instances of disorientation, using the GRAIL (Gait Real-Time Analysis Interactive Lab, Motekforce Link).

    The results will further enable the automatic detection of disorientation based on gait parameters, physiological and accelerometric data. This is necessary for the development of a situation-aware assistive system which supports persons with dementia in autonomous outdoor mobility.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of a Navigation Experiment in the Gait Real-Time Analysis Interactive Lab: Gait Analysis by Induced Disorientation in a VR Environment
    Actual Study Start Date :
    Mar 1, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Young Adults

    Neurologically healthy young adults between ages 18 and 40

    Older Adults

    Neurologically healthy older adults between ages 60 and 85

    Mild Cognitive Impairment/Mild Dementia

    Older adults between ages 60 and 85 with Mild Cognitive Impairment or Mild Dementia

    Outcome Measures

    Primary Outcome Measures

    1. Spatial disorientation [Up to 3 years from start of the study]

      Incidences of disorientation will be captured in a video record during the experiment, and then later identified in an off-line annotation procedure using a customized annotation scheme

    Secondary Outcome Measures

    1. Gait variability [Up to 3 years from start of the study]

      Incidences of change in gait pattern will be measured using the gait capturing system of the GRAIL (gait real-time analysis interactive lab)

    2. Spatial orientation ability [Up to 3 years from start of the study]

      Older adult participants' spatial orientation ability will be evaluated using the Perspective taking spatial orientation test (PTSOT). No predefined range. Lower scores indicate better spatial orientation ability. Formula: sum of true angles - sum of expressed angles

    3. Heart rate variability [Up to 3 years from start of the study]

      Rate of change in heart rate will be measured using a wearable electrocardiographic sensor

    4. Skin conductance [Up to 3 years from start of the study]

      Rate of change in electrodermal response will be measured using a wearable electrodermal activity sensor

    5. Accelerometery [Up to 3 years from start of the study]

      Incidences of change in walking pattern will be measured using accelerometers

    6. Apolipoprotein E4 status [Up to 3 years from start of the study]

      Presence of the variants Apo-E2, E3 and -E4 in the blood samples

    7. Visuospatial function [Up to 3 years from start of the study]

      Older adult participants' visual constructive ability will be evaluated using the figure copy part of the Rey-Osterrieth complex figure test (ROCF). Higher scores indicate better visual constructive ability. Range 0-31

    8. Memory function [Up to 3 years from start of the study]

      Older adult participants' spatial memory will be evaluated using the figure recall part of the Rey-Osterrieth complex figure test (ROCF). Higher scores indicate better memory. Range 0-31

    9. Executive function [Up to 3 years from start of the study]

      Older adult participants' executive function will be evaluated using the Trail making test (TMT A/B). Lower scores indicate better executive function. No predefined range

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Within the required age bracket

    • Mobile

    • Dementia

    Exclusion Criteria:
    • Other neurological conditions besides dementia

    • Inability to understand task instructions, deaf-mute, blindness

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock Rostock Mecklenburg-Western Pomerania Germany 18147

    Sponsors and Collaborators

    • University Medical Center Rostock
    • University of Rostock
    • German Center for Neurodegenerative Diseases (DZNE)

    Investigators

    • Principal Investigator: Stefan J. Teipel, Prof. Dr., University Medical Center Rostock

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Stefan Teipel, Prof. Dr., University Medical Center Rostock
    ClinicalTrials.gov Identifier:
    NCT04134806
    Other Study ID Numbers:
    • A 2019-0062
    First Posted:
    Oct 22, 2019
    Last Update Posted:
    May 8, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 8, 2020