Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R44HD084035 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BioSensics | INDUSTRY |
| MGH Institute of Health Professions | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Sham Comparator: Usual Care | Other | Stroke survivors randomized to this group will receive standard rehabilitation (i.e., physical and occupational therapy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StrokeWear Behavioral Intervention | Behavioral | 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. |
| 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 |
|---|---|---|
| Number of times the activity goals are reached | Number of times the activity goals set are reached over the study duration | At 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| 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 | Recruiting | Boston | Massachusetts | 02129 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Usual Care + Sham | 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. |
|
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 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
Not provided
Not provided
Not provided