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Gait Analysis by Induced Disorientation in a VR Environment

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ClinicalTrials.gov Identifier: NCT04134806
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : May 8, 2020
Sponsor:
Collaborators:
University of Rostock
German Center for Neurodegenerative Diseases (DZNE)
Information provided by (Responsible Party):
Stefan Teipel, University Medical Center Rostock

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
Mild Cognitive Impairment Mild Dementia Disorientation Young Adults Older Adults

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.

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Study Type : Observational
Estimated 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 : March 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort
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



Primary Outcome Measures :
  1. Spatial disorientation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 3 years from start of the study ]
    Incidences of change in walking pattern will be measured using accelerometers

  6. Apolipoprotein E4 status [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
7.5 millilitre blood sample for Apolipoprotein E4 (ApoE4) analysis


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy young adults, healthy older adults and older adults with mild cognitive impairment or mild dementia
Criteria

Inclusion Criteria:

  • Within the required age bracket
  • Mobile
  • Dementia

Exclusion Criteria:

  • Other neurological conditions besides dementia
  • Inability to understand task instructions, deaf-mute, blindness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134806


Contacts
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Contact: Chimezie O. Amaefule, M.Sc 0049-381-494-9478 chimezie.amaefule@dzne.de

Locations
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Germany
Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock Recruiting
Rostock, Mecklenburg-Western Pomerania, Germany, 18147
Contact: Stefan J. Teipel, Prof. Dr.    0049-381-494-9471    stefan.teipel@med.uni-rostock.de   
Principal Investigator: Stefan J. Teipel, Prof. Dr.         
Sponsors and Collaborators
University Medical Center Rostock
University of Rostock
German Center for Neurodegenerative Diseases (DZNE)
Investigators
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Principal Investigator: Stefan J. Teipel, Prof. Dr. University Medical Center Rostock
Publications:
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Responsible Party: Stefan Teipel, Prof. Dr., University Medical Center Rostock
ClinicalTrials.gov Identifier: NCT04134806    
Other Study ID Numbers: A 2019-0062
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Confusion
Cognitive Dysfunction
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms