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| ID | Type | Description | Link |
|---|---|---|---|
| R44AG063679 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Innovative Design Labs | INDUSTRY |
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This study tests an innovative system and service for collecting objective, consistent, and in-community gait parameters suitable for use as AD/ADRD biomarkers. The system is designed to be affordable, scalable, and practical for longitudinal, unsupervised, in-community use by older adults, including those with dementia symptoms. This study will be performed in two parts and involves collecting gait data from participants using the leg module and insole device either (1) for several hours in a lab setting (in-lab testing) or (2) within their home and community for 1 week (in-community testing). Thirty people who are healthy, have mild cognitive impairment, or who have Alzheimer's disease or related dementia will be recruited to participate in the in-lab testing, in which they will perform walking tasks and cognitive testing for several hours within a lab environment. After completion of in-lab testing, 120 individuals who are healthy, have mild cognitive impairment, or who have Alzheimer's disease or related dementia will be recruited to participate in the in-community testing, in which they will wear the insole and ankle device within their community for 1-week for collection of gait data in real world settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals using the insole and ankle device | Experimental | Participants will use the wearable leg module and insole device for either several hours in a lab environment or 1 week within their home and the community. Data will be recorded by the device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insole and ankle device | Device | Device that is worn as a shoe insole and around the ankle which will measure gait parameters to detect cognitive decline |
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| Measure | Description | Time Frame |
|---|---|---|
| In Lab Testing Primary Outcome: Mean absolute error of gait speed from the Short Physical Performance Battery and Timed Up and Go | Mean Absolute Error (MAE) of the gait speed during the Short Physical Performance Battery (SPPB) and Timed Up and GO (TUG) | Day 1 |
| In-Community Testing Primary Outcome: balanced accuracy of model developed using gait data | Balanced accuracy of cognitive impairment classification. This is the mean between recall of the positive and negative classes. | One week |
| Measure | Description | Time Frame |
|---|---|---|
| In Lab Testing Secondary Outcome: Average score on user feedback survey | Survey is on 5-point Likert scale, with higher score being more positive feedback. | Day 1 |
| In Community Secondary Outcome: Average score on user feedback survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | United States |
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Survey is 5-point Likert scale, with higher score being more positive feedback.
| 1 week |
| In Community Secondary Outcome: Device Failure Rate | Mechanical and software failures reported as per subject per day worn rate | 1 week |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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