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.
Age 55 or older
Ability to ambulate without the use of an assistive device. For this study, we will assume participants are ambulatory if they can complete the functional outcome measures (i.e., TUG) without the use of an assistive device
Ability to understand and provide informed consent, or has a legally authorized representative (LAR) to provide consent on their behalf
Ability to don and doff the insole and leg module independently or have assistance for the duration of the study
Non-English Speaking
Use of ankle-foot orthosis for ambulation that prevents use of the system
Self-reported acute thrombophlebitis including deep vein thrombosis
Untreated lymphedema or lesion of any kind, swelling, infection, inflamed area of skin or eruptions on or near product use (foot and ankle)
Single group
Insole and ankle device
DeviceDevice that is worn as a shoe insole and around the ankle which will measure gait parameters to detect cognitive decline
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)
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.
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.
In Community Secondary Outcome: Average score on user feedback survey
Survey is 5-point Likert scale, with higher score being more positive feedback.
In Community Secondary Outcome: Device Failure Rate
Mechanical and software failures reported as per subject per day worn rate
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HealthPartners Institute
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Innovative Design Labs
Collaborator
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