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| Name | Class |
|---|---|
| Moss Rehabilitation Research Institute | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this research study is to evaluate whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone.
Patients with arm weakness due to stroke that happened in the past 90-150 days will be randomized into one of two groups: [1] TR and usual care; [2] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.
This is a randomized, assessor-blinded study that involves the use of telerehabilitation to deliver additional therapy for persons with stroke. Patients with arm weakness due to stroke that happened in the past 90-150 days will be randomized into one of two groups: [1] TR and usual care; [2] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week 6-8 weeks. The hypothesis of this study is patients receiving TR in addition to their usual care will have significantly greater recovery of arm function compared to patients receiving usual care alone.
Study participation will last approximately 8 months and includes 4 in-person visits. At these visits, patients will undergo a variety of assessments including tests of arm function and a single MRI scan of the brain. Patients undergoing TR will receive arm motor training, which consists of 36 sessions of assigned exercises, games, and stroke education; these total 70 minutes in length and occur 6 days a week for 6 weeks; TR subjects will also continue usual care. Patients in the usual care group only will not engage in TR but will instead continue all of the therapies recommended by their medical team. At the end of the study, participants in the usual care group will be offered TR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Participants in the usual care group will receive no TR, but will continue with the recommendations made by their care team. All participants in this group will be offered TR at the end of the study. | |
| Telerehabilitation + Usual Care | Experimental | Patients will receive 36 telerehabilitation sessions targeting arm motor function in addition to their usual care. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | Device | The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Action Research Arm Test (ARAT) Score from Baseline to 2 Months | The ARAT scale measures arm function using a scale that runs from 0 to 57 points, with higher numbers reflecting better arm function. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in modified Rankin Scale (mRS) Score from Baseline to 2 Months | The mRS scale measures global function using a scale that runs from 0 to 6 points, with lower numbers reflecting better global function. | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Cramer, MD | Contact | (424)522-7874 | tr2trial@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Steven Cramer, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Los Amigos Research Institute | Not yet recruiting | Downey | California | 90242 | United States |
Non-PHI data will be shared with appropriate parties after the study is completed and published.
Any time after September 30, 2030
Appropriate parties with appropriate intention for use of the data, starting 9/30/30, with access to PHI-free data.
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Patients are randomized to TR + usual care or usual care alone
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| University of California, Irvine | Not yet recruiting | Irvine | California | 92868 | United States |
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| Keck Medical Center of USC | Recruiting | Los Angeles | California | 90033 | United States |
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| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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| Casa Colina Hospital and Centers for Healthcare | Recruiting | Pomona | California | 91767 | United States |
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| Hillcrest Medical Center at UC San Diego Health | Recruiting | San Diego | California | 92103 | United States |
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| Medstar Health Research Institute | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Brooks Rehabilitation Hospital | Not yet recruiting | Jacksonville | Florida | 32216 | United States |
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| Jackson Memorial Hospital Christine E. Lynn Rehabilitation Center | Not yet recruiting | Miami | Florida | 33136 | United States |
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| Emory Rehabilitation Hospital | Not yet recruiting | Atlanta | Georgia | 30322 | United States |
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| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| Massachusetts General Hospital | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
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| Spaulding Rehabilitation Hospital | Not yet recruiting | Charlestown | Massachusetts | 02129 | United States |
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| Baystate Medical Center | Recruiting | Springfield | Massachusetts | 01199 | United States |
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| University of Michigan University Hospital | Recruiting | Ann Arbor | Michigan | 48108 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| NYP Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
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| University of North Carolina Medical Center | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Duke University Hospital | Not yet recruiting | Durham | North Carolina | 27710 | United States |
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| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| MetroHealth Old Brooklyn Health Center | Not yet recruiting | Cleveland | Ohio | 44109 | United States |
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| Cleveland Clinic Foundation | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
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| Jefferson Moss Rehabilitation Research Institute | Recruiting | Elkins Park | Pennsylvania | 19027 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| The Institute for Rehabilitation and Research (TIRR) Memorial Hermann | Not yet recruiting | Houston | Texas | 77030 | United States |
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| UT Houston/Memorial Hermann Hospital TMC | Recruiting | Houston | Texas | 77030 | United States |
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| University of Utah Health | Recruiting | Salt Lake City | Utah | 84132 | United States |
|
| 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 |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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