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RECRUITING

NCT06787729

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

Sponsor: Spaulding Rehabilitation Hospital

View on ClinicalTrials.gov

Summary

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, intervention, and retention 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.

Official title: Motivation-Induced Movement Therapy: Enhancing Upper Limb Engagement in Stroke Survivors Through Ring Sensors and Data Visualization.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04

Completion Date

2027-07

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Stroke

Interventions

DEVICE

mHealth

The experimental design is composed of three phases: baseline, intervention, and retention. During the first two weeks (baseline), subjects will wear sensors, but no additional features (e.g., feedback, goal-setting, and weekly Zoom calls with clinicians) will be provided. For the next four weeks (intervention), subjects will wear sensors and have access to all intervention features, including weekly Zoom calls and goal-setting with clinicians. They will be encouraged to use the more impaired arm as much as possible. In the final two weeks (retention), the mobile intervention and clinician interactions will be removed, while subjects continue to wear sensors to examine the effects of withdrawing feedback.

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.

Locations (1)

Spaulding Rehabilitation Hospital, Motion Analysis Laboratory

Charlestown, Massachusetts, United States