Clinical trial NCT04134806: Gait Analysis by Induced Disorientation in a VR Environment
Official title: Evaluation of a Navigation Experiment in the Gait Real-Time Analysis Interactive Lab: Gait Analysis by Induced Disorientation in a VR Environment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Mild Dementia
Disorientation
Young Adults
Older Adults
Lead sponsor: University of Rostock
Sponsor class: OTHER
Collaborators: name: University of Rostock
name: German Center for Neurodegenerative Diseases (DZNE)
First posted: 2019-10-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy young adults, healthy older adults and older adults with mild cognitive impairment or mild dementia

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.

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.

Eligibility 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

Primary outcomes:
measure: Spatial disorientation
timeFrame: Up to 3 years from start of the study
Secondary outcomes:
measure: Gait variability
timeFrame: Up to 3 years from start of the study
measure: Spatial orientation ability
timeFrame: Up to 3 years from start of the study
measure: Heart rate variability
timeFrame: Up to 3 years from start of the study
measure: Skin conductance
timeFrame: Up to 3 years from start of the study
measure: Accelerometery
timeFrame: Up to 3 years from start of the study
measure: Apolipoprotein E4 status
timeFrame: Up to 3 years from start of the study
measure: Visuospatial function
timeFrame: Up to 3 years from start of the study
measure: Memory function
timeFrame: Up to 3 years from start of the study
measure: Executive function
timeFrame: Up to 3 years from start of the study
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock
state: Mecklenburg-Western Pomerania
Study officials:
affiliation: University Medical Center Rostock
name: Stefan J. Teipel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.