Gait Analysis by Induced Disorientation in a VR Environment

• Conditions: Mild Cognitive Impairment; Mild Dementia; Young Adults; Disorientation; Older Adults

• Registration Number: NCT04134806
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-22
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Within the required age bracket
• Mobile
• Dementia

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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
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
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
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
Accelerometery	Up to 3 years from start of the study	Incidences of change in walking pattern will be measured using accelerometers
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
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
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

Trial Locations

Locations (1)

Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock; 🇩🇪 Rostock, Mecklenburg-Western Pomerania, Germany