StrokeNCT06787729
At Home Wearable Sensors and Smartphone for Stroke Survivors With Upper Limb Motor Challenges.
A study testing mHealth in people with Stroke, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- mHealth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Spaulding Rehabilitation Hospital, Motion Analysis Laboratory
Charlestown, Massachusetts, 02474
Kathy Piela, PT, DPT, 617-952-6388, kpiela@mgb.org
Paolo Bonato, PhD
About this study
Official title: Motivation-Induced Movement Therapy: Enhancing Upper Limb Engagement in Stroke Survivors Through Ring Sensors and Data Visualization.
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?
Read more
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.
Read the detailed description
To test the efficacy of the mHealth intervention elements (i.e., feedback, goal setting, and communication), we will use the A (Baseline)-B (Intervention) design. The A-B design allows for an analysis of the effects of the introduction of the intervention elements, while providing all participants an opportunity to experience the novel intervention components.
During the baseline phase (week 0 - week 1), study participants will wear the wrist and index finger-worn sensors, bilaterally, for a total of 7 days. The app will also allow study participants to self-annotate their activities approximately every 90 minutes.
During the intervention phase (week 1 - week 4), study participants will be asked to wear the wrist and/or index finger-worn sensors, bilaterally, for the next 3 weeks, similar to the baseline phase. The primary difference is that the patient will be asked to actively interact with the Intervention app, which will provide visualization of the patient's limb activity level. The platform will send auto-reminders to subjects every day at their preferred morning time to remind them to wear the wearable sensors and interact with the app. Using the sensor data collected from the wearable devices, the app will visualize the daily and weekly summary of the participants' limb activity data and the goals set by the therapist and patient. Additionally, the app will allow participants to annotate their activities and show the annotations along with the data. During the intervention phase, the participant will engage in 2 separate Zoom calls with a research therapist to 1) review the limb activity during the week, 2) discuss barriers to using the more impaired arm and ways to overcome them, 3) adjust the goal setting for the following week, and 4) document the discussions.
Clinical assessments will be completed after enrollment and following the intervention phase.
- Conditions
- Stroke
- Being tested
- mHealth
- Keywords
- Hemiparesis, Upper extremity, Weakness, Arm, Hand, Ring Sensor, Wrist Sensor, mHealth, Stroke, Activities of daily living
- Medical subject headings
- Stroke, Paresis, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthDevice
The experimental design is composed of two phases: baseline and intervention. During the first week (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 three 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.
| Study group | Role | What they receive |
|---|---|---|
| mHealth Intervention | Experimental | Members of this group will receive the wearable sensors and mHealth smartphone application. Receives: Device: mHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Activity Log - Amount of Use
This outcome measure assesses upper extremity function and use through patient report.
Items are scored using a 6-point ordinal scale.
For the Amount Scale, 0=the weaker arm was not used at all for that activity (not used), while 5=the weaker arm was used as often as before the stroke (same as pre-stroke).
The score is calculated by adding the rating scores for each item and dividing by the number of items asked.
Measured: Week 0, Week 1, Week 4
Use Duration
This measure evaluates the duration for which a patient actively uses their stroke-affected limb during daily activities, as recorded by a wearable accelerometer placed on the stroke-affected index finger. The unit is minutes, with a range from 0 to 3600. A value of 0 indicates no use of the stroke-affected limb during the 24-hour period, while 3600 indicates continuous activity of the limb throughout the day. To compute Use Duration, the continuous accelerometer data is segmented into short intervals (e.g., one second), and the duration is calculated by counting the time intervals where the acceleration magnitude exceeds a threshold (e.g., > 1.134 g).
Measured: From enrollment to the end of the intervention period at 4 weeks
Secondary outcomes (2)
Motor Activity Log - Quality of Movement
This outcome measure assesses upper extremity function and use through patient report.
Items are scored using a 6-point ordinal scale.
For the How Well Scale, 0=the weaker arm was not used at all for that activity (not used), while 5=the ability to use the weaker arm for that activity was as good as before the stroke (normal).
The score is calculated by adding the rating scores for each item and dividing by the number of items asked.
Measured: Week 0, Week 1, Week 4
Use Ratio
This measure compares the activity levels of the stroke-affected limb to the less-affected limb. The range is from -log(3600) to log(3600). where -log(3600) indicates exclusive use of the stroke-affected limb, log(3600) indicates exclusive use of the less-affected limb, and 0 represents equal use of both limbs. Use Ratio is computed by first determining the Use Duration for both the stroke-affected and less-affected limbs using wearable accelerometers placed on their respective index fingers. The relationship is then calculated as the logarithm of the ratio of Use Durations: log(stroke-affected use duration/less-affected use duration).
Measured: From enrollment to the end of the intervention period at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start20 Apr 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We will use the A (Baseline)-B (Intervention) design. Each participant will serve as their own control.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Amherst, University of Maryland, College Park, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Director of Motion Analysis Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787729
- Sponsor's protocol ID
- 2024P003628
- Other IDs
- 5R01EB027777-05
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not included in the study participant consent form.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivation-Induced Movement Therapy: Enhancing Upper Limb Engagement in Stroke Survivors Through Ring Sensors and Data Visualization.
- ClinicalTrials.gov ID
- NCT06787729
- Acronym / sponsor ID
- 2024P003628
- Conditions
- Stroke
- Keywords
- Hemiparesis, Upper extremity, Weakness, Arm, Hand, Ring Sensor, Wrist Sensor, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- University of Massachusetts, Amherst, University of Maryland, College Park, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To test the efficacy of the mHealth intervention elements (i.e., feedback, goal setting, and communication), we will use the A (Baseline)-B (Intervention) design. The A-B design allows for an analysis of the effects of the introduction of the intervention elements, while providing all participants an opportunity to experience the novel intervention components.
During the baseline phase (week 0 - week 1), study participants will wear the wrist and index finger-worn sensors, bilaterally, for a total of 7 days. The app will also allow study participants to self-annotate their activities approximately every 90 minutes.
During the intervention phase (week 1 - week 4), study participants will be asked to wear the wrist and/or index finger-worn sensors, bilaterally, for the next 3 weeks, similar to the baseline phase. The primary difference is that the patient will be asked to actively interact with the Intervention app, which will provide visualization of the patient's limb activity level. The platform will send auto-reminders to subjects every day at their preferred morning time to remind them to wear the wearable sensors and interact with the app. Using the sensor data collected from the wearable devices, the app will visualize the daily and weekly summary of the participants' limb activity data and the goals set by the therapist and patient. Additionally, the app will allow participants to annotate their activities and show the annotations along with the data. During the intervention phase, the participant will engage in 2 separate Zoom calls with a research therapist to 1) review the limb activity during the week, 2) discuss barriers to using the more impaired arm and ways to overcome them, 3) adjust the goal setting for the following week, and 4) document the discussions.
Clinical assessments will be completed after enrollment and following the intervention phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We will use the A (Baseline)-B (Intervention) design. Each participant will serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| mHealth Intervention | Experimental | Device: mHealthMembers of this group will receive the wearable sensors and mHealth smartphone application. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealthThe experimental design is composed of two phases: baseline and intervention. During the first week (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 three 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. | Device | mHealth Intervention |
Primary outcome
Motor Activity Log - Amount of Use
Time frame: Week 0, Week 1, Week 4
This outcome measure assesses upper extremity function and use through patient report. Items are scored using a 6-point ordinal scale. For the Amount Scale, 0=the weaker arm was not used at all for that activity (not used), while 5=the weaker arm was used as often as before the stroke (same as pre-stroke). The score is calculated by adding the rating scores for each item and dividing by the number of items asked.
Use Duration
Time frame: From enrollment to the end of the intervention period at 4 weeks
This measure evaluates the duration for which a patient actively uses their stroke-affected limb during daily activities, as recorded by a wearable accelerometer placed on the stroke-affected index finger. The unit is minutes, with a range from 0 to 3600. A value of 0 indicates no use of the stroke-affected limb during the 24-hour period, while 3600 indicates continuous activity of the limb throughout the day. To compute Use Duration, the continuous accelerometer data is segmented into short intervals (e.g., one second), and the duration is calculated by counting the time intervals where the acceleration magnitude exceeds a threshold (e.g., > 1.134 g).
2 secondary outcomes
Motor Activity Log - Quality of Movement
Time frame: Week 0, Week 1, Week 4
Use Ratio
Time frame: From enrollment to the end of the intervention period at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. This is not included in the study participant consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paolo Bonato, PhD principal investigator
Director of Motion Analysis Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth in people with Stroke, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathy Piela, PT, DPT (617-952-6388, kpiela@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Activity Log - Amount of Use (time frame: Week 0, Week 1, Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.