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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSpaulding Rehabilitation Hospital

About this trial

The goal of this clinical trial is to learn if wearable sensor data visualization on smartphones can improve the use of the stroke-affected limb during everyday activities. Chronic stroke survivors (\>12 months from onset) ages 18-80 years old with residual upper extremity motor impairments may be eligible to participate. The main question it aims to answer is:

Does the mobile health (mHealth) intervention help to improve the use of the stroke-affected upper-limb during daily living?

The study is designed so each participant serves as their own control. Researchers will compare information from the baseline and intervention time periods to see if visualizing the data on the smartphone impacts the participant's daily use of the arm.

Participants will be asked to wear a set of wearable ring and wrist sensors and interact with a custom-designed smartphone app, aiming to increase the use of their stroke-affected limb during daily activities as much as possible. They will receive feedback from the app, communicate with study therapists, participate in goal setting, complete clinical assessments, and share about their experience using the system during a virtual interview.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • mHealth

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Spaulding Rehabilitation Hospital

Lead sponsor

University of Massachusetts, Amherst

Collaborator

University of Maryland, College Park

Collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator