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

Launched by SPAULDING REHABILITATION HOSPITAL · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether using wearable sensors and a smartphone app can help stroke survivors improve the use of their affected arm in daily activities. The researchers want to see if showing participants real-time data about their arm movements can encourage them to use their stroke-affected limb more often. To participate, individuals must be between 18 and 80 years old, have had a stroke more than a year ago, and still have some difficulty using their arm. They should also be comfortable using a smartphone app and believe they can take charge of their recovery.

Participants will wear special sensors on their wrist and fingers and interact with a user-friendly app designed to help them set goals and track their progress. They will receive feedback, have the chance to talk with therapists, and share their experiences in virtual interviews. The study aims to compare how much they use their affected arm before, during, and after the intervention. It's important to note that the trial is not yet recruiting participants, and certain health conditions may prevent individuals from joining.

Gender

ALL

Eligibility criteria

• 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 \< 2.5.
• • 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.