NCT04134806|Unknown
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
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Evaluation of a Navigation Experiment in the Gait Real-Time Analysis Interactive Lab: Gait Analysis by Induced Disorientation in a VR Environment
Sponsor study identifier
observational
80
1 country
1
Study Start
March 1, 2019
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2019
Actual (reported)October 18, 2019
Actual (reported)October 22, 2019
Actual (reported)December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Gait variability
Up to 3 years from start of the study
Spatial orientation ability
Up to 3 years from start of the study
Neurologically healthy young adults between ages 18 and 40
Neurologically healthy older adults between ages 60 and 85
Older adults between ages 60 and 85 with Mild Cognitive Impairment or Mild Dementia
Healthy young adults, healthy older adults and older adults with mild cognitive impairment or mild dementia
Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock
Rostock, Mecklenburg-Vorpommern, 18147, Germany
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.
7.5 millilitre blood sample for Apolipoprotein E4 (ApoE4) analysis
Stefan J. Teipel, Prof. Dr.
University Medical Center Rostock
First Submitted
October 18, 2019
First Posted
October 22, 2019
Study Start
March 1, 2019
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)Heart rate variability
Up to 3 years from start of the study
Skin conductance
Up to 3 years from start of the study
Accelerometery
Up to 3 years from start of the study
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 8, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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