NCT06787729 · Spaulding Rehabilitation Hospital
At Home Wearable Sensors and Smartphone for Stroke Survivors With Upper Limb Motor Challenges.
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Charlestown, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations