StrokeNCT06797154
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
A study testing StrokeWear Behavioral Intervention in people with Stroke and Stroke Sequelae, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in subacute stroke survivors. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Stroke Sequelae, Hemiparesis;Poststroke/CVA
- What is being tested?
- StrokeWear Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to 31 Aug 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-85 years of age at the time of enrollment
- Anterior circulation ischemic stroke at least 1 month and no more than 6 months prior to study enrollment;
- Unilateral upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 20 and 45;
- Intact cognitive function to understand the study procedures and goal setting (MMSE score above 23 and able to follow 3step command) ;
- Owning a smartphone (iOS or Android) and being familiar and comfortable with and owning a tablet or smartphone
- SAFE score equal or greater than 5
Who cannot join
- Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe performance of UE tasks;
- Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject ability to see the feedback on the app screen (as assessed with the Mesulum cancellation test);
- Individuals with open wounds or recent fracture (less than 3 months) in the upper extremity, fragile skin or active infection;
- Upper-extremity orthopedic injuries or severe pain resulting in movement limitations;
- Diagnosis of other neurological disease; (i.e., Parkinson's disease, multiple sclerosis, ...);
- Severe proprioceptive deficits that impair the ability to process the vibration feedback, as assessed by physical examination during screening;
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- Not understanding spoken or written English;
- Contralateral motor deficits as assessed by clinical examination;
- Brainstem and cerebellar stroke.
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
Boston, Massachusetts, 02129
Paolo Bonato, PhD, 617-952-6319, pbonato@partners.org
About this study
Official title: A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Subacute Stroke Survivors
The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in subacute stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).
Read the detailed description
The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in subacute stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).
Study participants will be asked to take part in 4 evaluation study visits: one screening and enrollment visit, and three evaluation visits (at baseline, at 3 months and at 6 months - at the intervention completion). Subject upper-extremity motor function will be assessed across domains of the International Classification of Functioning, Disability and Health (ICF) model. Groups will be stratified by baseline motor impairment and stroke chronicity.
Subjects randomized to the intervention group will take part of weekly coaching sessions during the first month, bi-weekly sessions during the months 2 and 3, and monthly sessions during months 4-6. These sessions will be held in-person or remotely, based on the study participant preference.
Subjects randomized to the control group will take part of monthly visits, held in-person or remotely (based on study participant preference), to re-evaluate the home-exercise plan and prescribe an update list of exercises for the following month.
- Conditions
- Stroke, Stroke Sequelae, Hemiparesis;Poststroke/CVA
- Being tested
- StrokeWear Behavioral Intervention, Usual Care + Sham
- Keywords
- StrokeWear, Biosensics, Behavioral Intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrokeWear Behavioral InterventionBehavioural
Behavioral strategies will be incorporated into the Strokewear system to encourage feedback on behavior, goal setting, daily activity action planning (DAAP), and an empowerment/ self management model to foster planned hemiparetic UE use during daily activities in the home and community. Patient empowerment in this study will occur over 6-months as patients gain the ability to use the StrokeWear technology independently and develop skills to self- manage their GDM and DAAP.
Usual Care + ShamOther
The intervention will consist in a sham version of the StrokeWear system and usual clinical care under the direction of a clinician. The sham version of the StrokeWear system will include sensing and recording technology to detect GDMs. However, study participants will not receive feedback from the system regarding the GDM counts.
| Study group | Role | What they receive |
|---|---|---|
| StrokeWear Motor and Behavioral Intervention | Experimental | Stroke survivors randomized to this group will receive standard rehabilitation (i.e., physical and occupational therapy) as well as a behavioral intervention aimed to encourage the use of the stroke affected arm during the performance of activities of daily living. Receives: Behavioral: StrokeWear Behavioral Intervention |
| Sham Comparator: Usual Care | Other | Stroke survivors randomized to this group will receive standard rehabilitation (i.e., physical and occupational therapy). Receives: Other: Usual Care + Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Motor Activity Log-Amount of Use
Self-reported measure of upper-extremity performance. Score from 0 (worst) to 5 (best)
Measured: Change from baseline Motor Activity Log-Amount of Use score at 6 months
Change in Fugl-Meyer Upper-Extremity
Observed measure of upper-extremity motor impairment following a stroke. Score from 0 (worst) to 66 (best)
Measured: Change from baseline Fugl-Meyer Upper-Extremity score at 6 months
Change in Upper-Extremity Activity Counts
Activity of the hemiparetic upper-extremity in the home setting as measured with wrist-worn accelerometers
Measured: Change from baseline Upper-Extremity Activity Counts score at 6 months
Secondary outcomes (6)
Change in Motor Activity Log-Quality of Use
Self-reported measure of upper-extremity quality of use. Score from 0 (worst) to 5 (best)
Measured: Change from baseline Motor Activity Log-Quality of Use score at 6 months
Change in Wolf-Motor Function Test - Time subscale
Observed (timed) measure of upper-extremity function. Time from 0 to 120 seconds (maximum time allowed to attempt to perform a motor task)
Measured: Change from baseline Wolf-Motor Function Test - Time subscale score at 6 months
Change in Wolf-Motor Function Test - Functional ability subscale
Measure of upper-extremity quality of movement based on visual observation. Score from 0 (worst) to 5 (best)
Measured: Change from baseline Wolf-Motor Function Test - Functional ability subscale score at 6 months
Change in Stroke Impact Scale (SIS)
Self-reported measure of quality of life after a stroke. Score from 0 (best) to 42 (worst)
Measured: Change from baseline Stroke Impact Scale (SIS) score at 6 months
Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale
Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best).
Measured: Change from baseline Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale score at 6 months
Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Self-management subscale
Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best).
Measured: Change from baseline Self-Efficacy Questionnaire (SSEQ) - Self-management subscale score at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start8 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BioSensics, MGH Institute of Health Professions, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797154
- Sponsor's protocol ID
- 2024P003622
- Other IDs
- R44HD084035
- Status last verified
- Nov 2025
- First submitted
- 21 Jan 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Subacute Stroke Survivors
- ClinicalTrials.gov ID
- NCT06797154
- Acronym / sponsor ID
- 2024P003622
- Conditions
- Stroke, Stroke Sequelae, Hemiparesis;Poststroke/CVA
- Keywords
- StrokeWear, Biosensics, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- BioSensics, MGH Institute of Health Professions, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 28 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 proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in subacute stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).
Detailed description
The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in subacute stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).
Study participants will be asked to take part in 4 evaluation study visits: one screening and enrollment visit, and three evaluation visits (at baseline, at 3 months and at 6 months - at the intervention completion). Subject upper-extremity motor function will be assessed across domains of the International Classification of Functioning, Disability and Health (ICF) model. Groups will be stratified by baseline motor impairment and stroke chronicity.
Subjects randomized to the intervention group will take part of weekly coaching sessions during the first month, bi-weekly sessions during the months 2 and 3, and monthly sessions during months 4-6. These sessions will be held in-person or remotely, based on the study participant preference.
Subjects randomized to the control group will take part of monthly visits, held in-person or remotely (based on study participant preference), to re-evaluate the home-exercise plan and prescribe an update list of exercises for the following month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StrokeWear Motor and Behavioral Intervention | Experimental | Behavioral: StrokeWear Behavioral InterventionStroke survivors randomized to this group will receive standard rehabilitation (i.e., physical and occupational therapy) as well as a behavioral intervention aimed to encourage the use of the stroke affected arm during the performance of activities of daily living. |
| Sham Comparator: Usual Care | Other | Other: Usual Care + ShamStroke survivors randomized to this group will receive standard rehabilitation (i.e., physical and occupational therapy). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 18-85 years of age at the time of enrollment
- Anterior circulation ischemic stroke at least 1 month and no more than 6 months prior to study enrollment;
- Unilateral upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 20 and 45;
- Intact cognitive function to understand the study procedures and goal setting (MMSE score above 23 and able to follow 3step command) ;
- Owning a smartphone (iOS or Android) and being familiar and comfortable with and owning a tablet or smartphone
Key exclusion criteria (9 listed)
- Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe performance of UE tasks;
- Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject ability to see the feedback on the app screen (as assessed with the Mesulum cancellation test);
- Individuals with open wounds or recent fracture (less than 3 months) in the upper extremity, fragile skin or active infection;
- Upper-extremity orthopedic injuries or severe pain resulting in movement limitations;
- Diagnosis of other neurological disease; (i.e., Parkinson's disease, multiple sclerosis, ...);
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 |
|---|---|---|
| StrokeWear Behavioral InterventionBehavioral strategies will be incorporated into the Strokewear system to encourage feedback on behavior, goal setting, daily activity action planning (DAAP), and an empowerment/ self management model to foster planned hemiparetic UE use during daily activities in the home and community. Patient empowerment in this study will occur over 6-months as patients gain the ability to use the StrokeWear technology independently and develop skills to self- manage their GDM and DAAP. | Behavioural | StrokeWear Motor and Behavioral Intervention |
| Usual Care + ShamThe intervention will consist in a sham version of the StrokeWear system and usual clinical care under the direction of a clinician. The sham version of the StrokeWear system will include sensing and recording technology to detect GDMs. However, study participants will not receive feedback from the system regarding the GDM counts. | Other | Sham Comparator: Usual Care |
Primary outcome
Change in Motor Activity Log-Amount of Use
Time frame: Change from baseline Motor Activity Log-Amount of Use score at 6 months
Self-reported measure of upper-extremity performance. Score from 0 (worst) to 5 (best)
Change in Fugl-Meyer Upper-Extremity
Time frame: Change from baseline Fugl-Meyer Upper-Extremity score at 6 months
Observed measure of upper-extremity motor impairment following a stroke. Score from 0 (worst) to 66 (best)
Change in Upper-Extremity Activity Counts
Time frame: Change from baseline Upper-Extremity Activity Counts score at 6 months
Activity of the hemiparetic upper-extremity in the home setting as measured with wrist-worn accelerometers
6 secondary outcomes
Change in Motor Activity Log-Quality of Use
Time frame: Change from baseline Motor Activity Log-Quality of Use score at 6 months
Change in Wolf-Motor Function Test - Time subscale
Time frame: Change from baseline Wolf-Motor Function Test - Time subscale score at 6 months
Change in Wolf-Motor Function Test - Functional ability subscale
Time frame: Change from baseline Wolf-Motor Function Test - Functional ability subscale score at 6 months
Change in Stroke Impact Scale (SIS)
Time frame: Change from baseline Stroke Impact Scale (SIS) score at 6 months
Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale
Time frame: Change from baseline Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale score at 6 months
Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Self-management subscale
Time frame: Change from baseline Self-Efficacy Questionnaire (SSEQ) - Self-management subscale score at 6 months
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 28 Nov 2025.
- Individual participant dataSharing planned: No
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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
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StrokeWear Behavioral Intervention in people with Stroke and Stroke Sequelae, 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 6 inclusion and 9 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 28 Nov 2025. 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 Paolo Bonato, PhD (617-952-6319, pbonato@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Motor Activity Log-Amount of Use (time frame: Change from baseline Motor Activity Log-Amount of Use score at 6 months). The study lists 3 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 28 Nov 2025.