An observational study in Mild Cognitive Impairment, Mild Dementia and Disorientation, sponsored by University Medical Center Rostock. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-08.
Sponsored by University Medical Center Rostock · Observational
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.
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.
3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.
This study's planned enrollment of 80 is below the median of 150 across 989 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University Medical Center Rostock is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy young adults, healthy older adults and older adults with mild cognitive impairment or mild dementia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Time frame: Up to 3 years from start of the study
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 3 years from start of the study
Accelerometery
Incidences of change in walking pattern will be measured using accelerometers
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 3 years from start of the study
Plan to share: No
Started Mar 2019 (actual). Primary completion is estimated for Dec 2021, 33 months after the start.
Of 515 non-industry observational studies under Cognitive Dysfunction, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 124. This study's planned 33 months is below that.
Counting every sponsor, half of 551 studies reached it within 48 months; a quarter within 21 and three quarters within 118.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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University Medical Center Rostock