Mild Cognitive ImpairmentNCT04134806
Gait Analysis by Induced Disorientation in a VR Environment
An observational study of Mild Cognitive Impairment and Mild Dementia, run by University Medical Center Rostock at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia, Disorientation
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy young adults, healthy older adults and older adults with mild cognitive impairment or mild dementia
Who may be able to join
- Within the required age bracket
- Mobile
- Dementia
Who cannot join
- Other neurological conditions besides dementia
- Inability to understand task instructions, deaf-mute, blindness
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock
Rostock, Mecklenburg-Vorpommern, 18147
Stefan J. Teipel, Prof. Dr., 0049-381-494-9471, stefan.teipel@med.uni-rostock.de
Stefan J. Teipel, Prof. Dr.
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Cognitive Dysfunction, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 3 years from start of the study
Secondary outcomes (9)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 3 years from start of the study
Accelerometery
Incidences of change in walking pattern will be measured using accelerometers
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 3 years from start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rostock, German Center for Neurodegenerative Diseases (DZNE)
- Responsible party
- Principal investigator, Stefan Teipel, University Medical Center Rostock
- Investigators
- Stefan J. Teipel, Prof. Dr., Principal investigator, University Medical Center Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134806
- Sponsor's protocol ID
- A 2019-0062
- Status last verified
- May 2020
- First submitted
- 18 Oct 2019
- Last updated
- 8 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31362286Yordanova 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.
PubMed 29060937Amaefule 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.
PubMed 33030436
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Navigation Experiment in the Gait Real-Time Analysis Interactive Lab: Gait Analysis by Induced Disorientation in a VR Environment
- ClinicalTrials.gov ID
- NCT04134806
- Acronym / sponsor ID
- A 2019-0062
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Medical Center RostockUniversity, hospital or other
- Collaborators
- University of Rostock, German Center for Neurodegenerative Diseases (DZNE)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy young adults, healthy older adults and older adults with mild cognitive impairment or mild dementia
Key inclusion criteria (3 listed)
- Within the required age bracket
- Mobile
- Dementia
Key exclusion criteria (2 listed)
- Other neurological conditions besides dementia
- Inability to understand task instructions, deaf-mute, blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spatial disorientation
Time frame: 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
9 secondary outcomes
Gait variability
Time frame: Up to 3 years from start of the study
Spatial orientation ability
Time frame: Up to 3 years from start of the study
Heart rate variability
Time frame: Up to 3 years from start of the study
Skin conductance
Time frame: Up to 3 years from start of the study
Accelerometery
Time frame: Up to 3 years from start of the study
Apolipoprotein E4 status
Time frame: Up to 3 years from start of the study
Visuospatial function
Time frame: Up to 3 years from start of the study
Memory function
Time frame: Up to 3 years from start of the study
Executive function
Time frame: Up to 3 years from start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Background: PubMed 31362286Schaat 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.
- Background: PubMed 29060937Yordanova 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.
- Derived from this study: PubMed 33030436Amaefule 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan J. Teipel, Prof. Dr. principal investigator
University Medical Center Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Mild Dementia, run by University Medical Center Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chimezie O. Amaefule, M.Sc (0049-381-494-9478, chimezie.amaefule@dzne.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial disorientation (time frame: Up to 3 years from start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04134806, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.