An interventional study of mHealth in Stroke, sponsored by Spaulding Rehabilitation Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 50 is close to the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Spaulding Rehabilitation Hospital is the lead sponsor of 117 studies on the registry; 27 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 17 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Members of this group will receive the wearable sensors and mHealth smartphone application.
Device: mHealth
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.
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.
Time frame: 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).
Time frame: From enrollment to the end of the intervention period at 4 weeks
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.
Time frame: 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).
Time frame: From enrollment to the end of the intervention period at 4 weeks
Fugl-Meyer Assessment, Upper Extremity - Motor
This is a motor function assessment for stroke survivors who have hemiplegia. Items are scored on a 3-point ordinal scale where 0=cannot perform, 1=performs partially, and 2=performs fully. Higher scores are indicative of higher function. Maximum score=66.
Time frame: Week 0, Week 1, Week 4
Wolf Motor Function Test - Functional Ablility
This assessment evaluates motor ability of the upper extremity during timed and functional tasks. Functional ability scores are assigned using a 6-point ordinal scale, and the maximum score is 75. A score of 0=does not attempt with the involved arm and a score of 5=arm does participate; movement appears to be normal. Higher scores are indicative of higher function.
Time frame: Week 0, Week 1, Week 4
Wolf Motor Function Test - Performance Time
This assessment evaluates motor ability of the upper extremity during timed and functional tasks. Performance time is measured in seconds, with up to 120 seconds allowed.
Time frame: Week 0, Week 1, Week 4
Box and Block Test
The test is an assessment of unilateral gross manual dexterity. It is performed with each hand separately, the stroke-affected hand and the non-affected hand. The scored is calculated by counting the number of blocks that were carried over the partition from one side of the box to the other side of the box in 1 minute. Higher scores are indicative of better gross manual dexterity.
Time frame: Week 0, Week 1, Week 4
Plan to share: No — This is not included in the study participant consent form.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Jan 2027, 9 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 9 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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