Gait Analysis by Induced Disorientation in a VR Environment

NCT ID: NCT04134806

Last Updated: 2020-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mild Cognitive Impairment Mild Dementia Disorientation Young Adults Older Adults

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Young Adults

Neurologically healthy young adults between ages 18 and 40

No interventions assigned to this group

Older Adults

Neurologically healthy older adults between ages 60 and 85

No interventions assigned to this group

Mild Cognitive Impairment/Mild Dementia

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Within the required age bracket
* Mobile
* Dementia

Exclusion Criteria

* Other neurological conditions besides dementia
* Inability to understand task instructions, deaf-mute, blindness
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rostock

OTHER

Sponsor Role collaborator

German Center for Neurodegenerative Diseases (DZNE)

OTHER

Sponsor Role collaborator

University Medical Center Rostock

OTHER

Sponsor Role lead

Responsible Party

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Stefan Teipel

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan J. Teipel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Rostock

Locations

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Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Chimezie O. Amaefule, M.Sc

Role: CONTACT

0049-381-494-9478

Facility Contacts

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Stefan J. Teipel, Prof. Dr.

Role: primary

0049-381-494-9471

References

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Schaat S, Koldrack P, Yordanova K, Kirste T, Teipel S. Real-Time Detection of Spatial Disorientation in Persons with Mild Cognitive Impairment and Dementia. Gerontology. 2020;66(1):85-94. doi: 10.1159/000500971. Epub 2019 Jul 30.

Reference Type BACKGROUND
PMID: 31362286 (View on PubMed)

Yordanova K, Koldrack P, Heine C, Henkel R, Martin M, Teipel S, Kirste T. Situation Model for Situation-Aware Assistance of Dementia Patients in Outdoor Mobility. J Alzheimers Dis. 2017;60(4):1461-1476. doi: 10.3233/JAD-170105.

Reference Type BACKGROUND
PMID: 29060937 (View on PubMed)

Amaefule CO, Ludtke S, Kirste T, Teipel SJ. Effect of Spatial Disorientation in a Virtual Environment on Gait and Vital Features in Patients with Dementia: Pilot Single-Blind Randomized Control Trial. JMIR Serious Games. 2020 Oct 8;8(4):e18455. doi: 10.2196/18455.

Reference Type DERIVED
PMID: 33030436 (View on PubMed)

Other Identifiers

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A 2019-0062

Identifier Type: -

Identifier Source: org_study_id

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