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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD065438 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study is about rehabilitation of arm function after a stroke. The investigators are testing the dosage of therapy that is needed for meaningful recovery of arm and hand function. Dosage of therapy refers to the amount of time (in this case, the total number of hours) that a person participates in treatment. The investigators hope to learn how much therapy time is needed in order for change to occur in arm and hand function after a person has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or hand at least 6 months ago.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Therapy Dose | Experimental | Sixty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist). |
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| Moderate Therapy Dose | Experimental | Thirty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist). |
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| Low Therapy Dose | Experimental | Fifteen total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist). |
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| Active Monitoring | Other | This is an observation only group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated Skill Acquisition Program (ASAP) | Behavioral | A focused, intense, evidence-based, upper extremity rehabilitation program. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence Dosage of therapy (number of hours of therapy) will vary based on group assignment. Frequency is 4x/week, 1 week per month for 3 months in a train-wait-train paradigm. A 2-hour orientation session precedes the first visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Bilateral Arm Reaching Test (BART) | BART is a laboratory-based timed-reaching task for people with stroke that was developed to evaluate upper extremity use in free-choice and forced-use scenarios. BART will be performed two times per month for the four months following randomization, and one time a month for 6 months during the follow-up period to assess changes in upper extremity use relative to dosage of therapy. | Change from Baseline to up to 4 months post-randomization |
| Wolf Motor Function Test (WMFT) | Tests arm function based on time to complete 15 tasks performed with each arm. WMFT will be used to assess change in arm function relative to dose of physical therapy. | Change from Baseline to up to 4 months post-randomization |
| Motor Activity Log (MAL) | Semi-structured interview in which participants are asked to rate the quality of movement (QOM) of their more affected arm for 28 activities of daily living. MAL is used to assess changes in participant perspective of arm use in daily life relative to dose of physical therapy. | Change from Baseline to up to 4 months post-randomization |
| Bilateral Arm Reaching Test (BART) | BART is a laboratory-based timed-reaching task for people with stroke that was developed to evaluate upper extremity use in free-choice and forced-use scenarios. BART will be performed 2 times at Baseline, pre- and post- intervention and 1 time a month for 6 months during follow-up to assess changes in upper extremity use relative to dosage of therapy. | Change from Baseline to up to 10 months post-randomization |
| Wolf Motor Function Test (WMFT) | Tests arm function based on time to complete 15 tasks performed with each arm. WMFT will be used to assess change in arm function relative to dose of physical therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Impact Scale (SIS) | A self-report measure to assess the ways in which an individual's health and life are impacted after a stroke. SIS will be used to assess changes in participant self-report of the impact of the stroke on health and life relative to dosage of physical therapy. | Change from Baseline to up to 4 months post-randomization |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolee Winstein, PhD, PT, FAPTA | University of Southern California | Principal Investigator |
| Nicolas Schweighofer, PhD | University of Southern California | Principal Investigator |
| Clarisa Martinez, PT, DPT | University of Southern California | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California-Health Sciences Campus | Los Angeles | California | 90089 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37386512 | Derived | Schweighofer N, Ye D, Luo H, D'Argenio DZ, Winstein C. Long-term forecasting of a motor outcome following rehabilitation in chronic stroke via a hierarchical bayesian dynamic model. J Neuroeng Rehabil. 2023 Jun 29;20(1):83. doi: 10.1186/s12984-023-01202-y. | |
| 31164067 | Derived | Winstein C, Kim B, Kim S, Martinez C, Schweighofer N. Dosage Matters. Stroke. 2019 Jul;50(7):1831-1837. doi: 10.1161/STROKEAHA.118.023603. Epub 2019 Jun 5. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| Active Monitoring | Behavioral | This is an observation-only group. Any therapy received while in this group will be dosed according to usual and customary practice. |
|
| Change from Baseline to up to 10 months post-randomization |
| Motor Activity Log (MAL) | Semi-structured interview in which participants are asked to rate the quality of movement (QOM) of their more affected arm for 28 activities of daily living. MAL is used to assess changes in participant perspective of arm use in daily life relative to dose of physical therapy. | Change from Baseline to up to 10 months post-randomization |
| Upper Extremity Fugl-Meyer (UEFM) | A test of motor function and sensation for the arm that is most affected by the stroke. UEFM will assess change in motor function relative to dose of physical therapy. | Change from Baseline to up to 4 months post-randomization |
| Stroke Impact Scale (SIS) | A self-report measure to assess the ways in which an individual's health and life are impacted after a stroke. SIS will be used to assess changes in participant self-report of the impact of the stroke on health and life relative to dosage of physical therapy. | Change from Baseline to up to 10 months post-randomization |
| Upper Extremity Fugl-Meyer (UEFM) | A test of motor function and sensation for the arm that is most affected by the stroke. UEFM will assess change in motor function relative to dose of physical therapy. | Change from Baseline to up to 10 months post-randomization |
| D002318 | Cardiovascular Diseases |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |