Wearable sensors and a smartphone app to help you use your affected arm at home.
Motivation-Induced Movement Therapy: Enhancing Upper Limb Engagement in Stroke Survivors Through Ring Sensors and Data Visualization.
This trial tests whether a smartphone app that visualizes data from wrist and finger wearables helps people more than 12 months after stroke use their affected arm more during daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 1 site (Charlestown, Massachusetts) |
| Trial ID | NCT06787729 on ClinicalTrials.gov |
What this trial studies
Participants with chronic stroke and residual upper-limb motor impairment wear bilateral wrist and index-finger sensors and use a custom smartphone app. The study uses an A (baseline) – B (intervention) design so each person serves as their own control, with one week of baseline monitoring followed by three weeks of active app use that provides visualized activity feedback, reminders, goal tracking, and activity annotations. Researchers compare sensor-derived limb use metrics from the baseline and intervention periods to see if the visual feedback increases everyday use of the affected arm. Enrollment targets adults 18–80 who can perform minimal wrist and finger extension and are regular smartphone users.
Who should consider this trial
Good fit: Ideal candidates are adults 18–80 who are more than 12 months post-stroke with residual upper-extremity weakness but at least minimal wrist and finger extension, who regularly use a smartphone and can read English.
Not a fit: Patients with significant cognitive impairment, those who cannot meet the wrist/finger movement criteria, people unwilling or unable to use a smartphone or wear sensors, and those less than 12 months post-stroke are unlikely to benefit.
Why it matters
Potential benefit: If successful, the app plus wearables could increase everyday use of the affected arm and support improved function and independence.
How similar studies have performed: Prior mHealth and wearable-feedback studies in chronic stroke have shown promising but mixed improvements in arm use, so this approach builds on emerging evidence rather than an established standard.
Eligibility criteria
Show full inclusion / exclusion 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 \</= 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.
Where this trial is running
Charlestown, Massachusetts
- Spaulding Rehabilitation Hospital, Motion Analysis Laboratory — Charlestown, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Paolo Bonato, PhD — Director of Motion Analysis Laboratory
- Study coordinator: Kathy Piela, PT, DPT
- Email: kpiela@mgb.org
- Phone: 617-952-6388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.