Gait Analysis by Induced Disorientation in a VR Environment

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Chimezie O. Amaefule, M.Sc; Phone Number: 0049-381-494-9478; Email: chimezie.amaefule@dzne.de

Study Locations

• Germany
  • Mecklenburg-Western Pomerania
    • Rostock, Mecklenburg-Western Pomerania, Germany, 18147
      • Recruiting
      • Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock
      • Contact: Stefan J. Teipel, Prof. Dr.; Phone Number: 0049-381-494-9471; Email: stefan.teipel@med.uni-rostock.de
      • Principal Investigator: Stefan J. Teipel, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy young adults, healthy older adults and older adults with mild cognitive impairment or mild dementia

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Accelerometery	Incidences of change in walking pattern will be measured using accelerometers	Up to 3 years from start of the study
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
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
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
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

Collaborators and Investigators

• Sponsor: University Medical Center Rostock
• Collaborators: University of Rostock; German Center for Neurodegenerative Diseases (DZNE)
• Investigators: Principal Investigator: Stefan J. Teipel, Prof. Dr., University Medical Center Rostock

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Confusion
• Other Study ID Numbers: A 2019-0062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No