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| ID | Type | Description | Link |
|---|---|---|---|
| R44HD084035 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| BioSensics | INDUSTRY |
| MGH Institute of Health Professions | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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 chronic 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).
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 chronic 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StrokeWear Motor and Behavioral Intervention | Experimental | Stroke survivors randomized to this group will receive standard occupational and physical therapy in addition to a behavioral intervention aimed to encourage stroke survivors to use their affect arm during the performance of activities of daily living. |
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| Usual Care | Sham Comparator | Stroke survivors randomized to this group will receive standard occupational and physical therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StrokeWear Motor and Behavioral Intervention | Combination Product | The intervention will consist of 1) the use of StrokeWear for goal directed movements (GDM) feedback and goal setting, 2) use of daily activity action planning (DAAP) to foster planned hemiparetic UE use during daily activities in the home and community, and 3) patient empowerment. 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 manage their GDM and DAAP. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor Activity Log-Amount of Use | Self-reported measure of upper-extremity performance. Score from 0 (worst) to 5 (best) | 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) | 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 | Change from baseline Upper-Extremity Activity Counts score at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor Activity Log-Quality of Use | Self-reported measure of upper-extremity quality of use. Score from 0 (worst) to 5 (best) | Change from baseline Motor Activity Log-Quality of Use score at 6 months |
| Change in Wolf-Motor Function Test - Time subscale |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Canadian Occupational Performance Measure (COPM) | Semi-structured interview to assess outcomes in the areas of self-care, productivity and leisure. Score from 0 (worst) to 10 (best). | Change from baseline Canadian Occupational Performance Measure (COPM) score at 6 months |
| Number of times the activity goals are reached |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Bonato, PhD | Contact | 617-952-6319 | pbonato@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonato, PhD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital Boston | Recruiting | Boston | Massachusetts | 02129 | United States |
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| Usual Care | Other | 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. |
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Observed (timed) measure of upper-extremity function. Time from 0 to 120 seconds (maximum time allowed to attempt to perform a motor task) |
| 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) | 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) | 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). | 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). | Change from baseline Self-Efficacy Questionnaire (SSEQ) - Self-management subscale score at 6 months |
Number of times the activity goals set are reached over the study duration |
| At 6 months |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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