At Home Wearable Sensors and Smartphone for Stroke Survivors With Upper Limb Motor Challenges.

To test the efficacy of the mHealth intervention elements (i.e., feedback, goal setting, and communication), we will use the A (Baseline)-B (Intervention) design. The A-B design allows for an analysis of the effects of the introduction of the intervention elements, while providing all participants an opportunity to experience the novel intervention components.

During the baseline phase (week 0 - week 1), study participants will wear the wrist and index finger-worn sensors, bilaterally, for a total of 7 days. The app will also allow study participants to self-annotate their activities approximately every 90 minutes.

During the intervention phase (week 1 - week 4), study participants will be asked to wear the wrist and/or index finger-worn sensors, bilaterally, for the next 3 weeks, similar to the baseline phase. The primary difference is that the patient will be asked to actively interact with the Intervention app, which will provide visualization of the patient's limb activity level. The platform will send auto-reminders to subjects every day at their preferred morning time to remind them to wear the wearable sensors and interact with the app. Using the sensor data collected from the wearable devices, the app will visualize the daily and weekly summary of the participants' limb activity data and the goals set by the therapist and patient. Additionally, the app will allow participants to annotate their activities and show the annotations along with the data. During the intervention phase, the participant will engage in 2 separate Zoom calls with a research therapist to 1) review the limb activity during the week, 2) discuss barriers to using the more impaired arm and ways to overcome them, 3) adjust the goal setting for the following week, and 4) document the discussions.

Clinical assessments will be completed after enrollment and following the intervention phase.

Inclusion criteria

• Stroke survivor (ischemic or hemorrhagic), >12 months post stroke, at the time of consent
• Aged between 18 and 80
• Ability to extend ≥ 10° at the metacarpophalangeal joint and one of the interphalangeal joints of each finger, ≥ 10° extension or abduction of the thumb, and ≥ 20° extension of the wrist from a fully flexed starting position.
• Demonstrating more affected arm nonuse, defined as a MAL-AoU score of </= 4.5.
• Actively uses at least one smartphone app.
• Strong beliefs towards being in control of their recovery, indicated by a score of ≤ 10 points on the Internal Recovery Locus of Control (I-RLOC) Scale.
• Participants must be able to read, write, and understand English at a level sufficient to comprehend study materials and provide informed consent.

Exclusion criteria

• Cognitive impairments that may affect the ability to understand and follow instructions (score < 24 in the Mini Mental State Examination)
• Difficulties comprehending numbers, dyslexia, severe aphasia, or other neurological conditions that prohibit the use of smartphones for safety reasons.
• Undergoing other types of motor therapy during the study period.
• Previous participation in constraint-induced movement therapy.
• Currently participating in or has participated in the past 3 months in any experimental rehabilitation or drug studies.
• Use of botulinum toxin for motor disability ≤ 3 months before treatment.
• Significant changes in pharmacological or treatment plans during the study period that may affect upper-limb use.
• Major medical problems that could interfere with participation.
• History of a disabling stroke (i.e., need more than minimum assistance to perform ADLs).
• Legally blind status.
• Uncontrolled seizures.
• Inability to don/doff sensors independently or with the assistance of a caregiver.
• Implantable medical devices that do not comply with the ISO 14117:2012 and/or ANSI/AAMI PC69 standards for electromagnetic compatibility. Subjects will be asked to provide their medical device record card, and non-compliant devices will result in exclusion from the study.