Gait Analysis by Induced Disorientation in a VR Environment

Mild Cognitive Impairment Clinical Trial

Official title:

Evaluation of a Navigation Experiment in the Gait Real-Time Analysis Interactive Lab: Gait Analysis by Induced Disorientation in a VR Environment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04134806
• Other study ID #: A 2019-0062
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2020
• Source: University of Rostock
• Contact: Chimezie O. Amaefule, M.Sc
• Phone: 0049-381-494-9478
• Email: chimezie.amaefule[@]dzne.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Within the required age bracket

• Mobile

• Dementia

Exclusion Criteria:

• Other neurological conditions besides dementia

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Confusion
• Disorientation
• Mild Cognitive Impairment
• Mild Dementia
• Older Adults
• Young Adults

Locations

Country	Name	City	State
Germany	Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock	Rostock	Mecklenburg-Western Pomerania

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Rostock	German Center for Neurodegenerative Diseases (DZNE), University of Rostock

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatial disorientation	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	Up to 3 years from start of the study
Secondary	Gait variability	Incidences of change in gait pattern will be measured using the gait capturing system of the GRAIL (gait real-time analysis interactive lab)	Up to 3 years from start of the study
Secondary	Spatial orientation ability	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	Up to 3 years from start of the study
Secondary	Heart rate variability	Rate of change in heart rate will be measured using a wearable electrocardiographic sensor	Up to 3 years from start of the study
Secondary	Skin conductance	Rate of change in electrodermal response will be measured using a wearable electrodermal activity sensor	Up to 3 years from start of the study
Secondary	Accelerometery	Incidences of change in walking pattern will be measured using accelerometers	Up to 3 years from start of the study
Secondary	Apolipoprotein E4 status	Presence of the variants Apo-E2, E3 and -E4 in the blood samples	Up to 3 years from start of the study
Secondary	Visuospatial function	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	Up to 3 years from start of the study
Secondary	Memory function	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	Up to 3 years from start of the study
Secondary	Executive function	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	Up to 3 years from start of the study