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| Name | Class |
|---|---|
| Georgetown University | OTHER |
| University of Wisconsin, Madison | OTHER |
| The Catholic University of America | OTHER |
| Medstar Health Research Institute |
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To perform an exploratory single center randomized study that will form the basis for a larger scale, more definitive randomized clinical trial to determine the optimal time after stroke for intensive motor training. The investigators will perform a prospective exploratory study of upper extremity (UE) motor training delivered at higher than usual intensity at three different time points after stroke:
The control group will not receive the therapy intervention during the 1-year study.
Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and one year after stroke onset.
Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or chronic (6-9 months after stroke onset) time points, participants randomized to early intensive motor training will show greater upper extremity motor improvement measured at one year post stroke.
Please see the following reference:
Dromerick, A.W., Edwardson, M., Edwards, D.F., Giannetti, M.L., Barth, J., Brady, K.P., Chan, E., Tan, M.T., Tamboli, I., Chia, R., Orquiza, M., Padilla, R.M., Cheema, A.K., Mapstone, M., Fiandaca, M.S., Federoff, H.J., & Newport, E.L. (2015). Critical Periods after Stroke Study: Translating animal stroke recovery experiments into a clinical trial. Frontiers in Human Neuroscience, 9, 002231. PMCID: PMC4413691.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute/Early | Experimental | Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke. |
|
| Sub-acute/Outpatient | Experimental | Intervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke. |
|
| Chronic | Experimental | Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke |
|
| Control | Placebo Comparator | Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Intensive upper extremity motor training | Behavioral | Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 30 days of stroke onset. |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test (ARAT) | The ARAT assesses functional limitations and evaluates changes in limb function for the upper extremity. | Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Activity Log - 28 Quality of Movement (MAL-28 QOM) | A structured interview to measure upper extremity use and function as well as assess the quality of movement of the hemiparetic arm. | Pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Assessment Scale - Upper Arm Function (MAS) | Performance-based scale to assess everyday motor function. | Baseline (within 30 days of stroke onset) |
Inclusion Criteria:
Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) within 28 days of admission to inpatient rehabilitation (allows those randomized to the early arm to begin study-related treatment within 30 days)
Age >21 years
Able to participate in first study-related treatment session within 30 days of stroke onset
Able to participate in all study-related activities, including one year follow up and blood draws
Persistent hemiparesis leading to impaired upper extremity function. Hemiparesis as indicated by NIHSS Motor Arm score ≥ 1
Recovering moderate motor impairment at the shoulder and elbow or hand such as:
or
or
Active range of motion (AROM) to at least 50% of range in gravity eliminated position for shoulder flexion or abduction, and for any of the following motions: elbow flexion, elbow extension, wrist flexion, wrist extension, finger flexion or finger extension.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander W Dromerick, MD | MedStar National Rehabilitation Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar National Rehabilitation Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25972803 | Background | Dromerick AW, Edwardson MA, Edwards DF, Giannetti ML, Barth J, Brady KP, Chan E, Tan MT, Tamboli I, Chia R, Orquiza M, Padilla RM, Cheema AK, Mapstone ME, Fiandaca MS, Federoff HJ, Newport EL. Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial. Front Hum Neurosci. 2015 Apr 29;9:231. doi: 10.3389/fnhum.2015.00231. eCollection 2015. | |
| 34168611 |
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There is no plan at this time to make individual participant data available.
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| OTHER |
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| Sub-acute intensive upper extremity motor training | Behavioral | Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 2 to 3 months post stroke. |
|
| Chronic intensive upper extremity motor training | Behavioral | Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 6 to 9 months post stroke. |
|
| Control | Behavioral | Usual and Customary Care only. No additional therapy will be given during the 1-year study. |
|
| Nine Hole Peg Test (9-HPT) |
A standardized quantitative test of upper extremity function and fine manual dexterity. |
| Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke |
| Functional Independence Measure (FIM) | A basic indicator of severity of disability. Tracks changes in the functional ability of the patient during an episode of hospital rehabilitation care. | Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke |
| Barthel Index (BI) | Measures performance in activities of daily living and functional disability. | Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke |
| Motricity Index - Arm only (MI) | To assess motor impairment and strength in the upper extremity. | Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke |
| Perception of change (POC) | A stroke-specific self-report to assess how stroke has impacted a person's life and their overall perception of recovery. | Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke |
| Stroke Impact Scale - Hand-Arm subscale (SIS) | A self-report health status measure to assess perceived recovery with regard to the more affected hand and arm following a stroke. | Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke |
| Modified Rankin Scale (MRS) | A measure of the degree of disability or dependence in daily activities following a stroke. | Baseline (pre-stroke assessment), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke |
| Activity Card Sort (ACS) | An interview-based assessment used to measure an individual's participation in instrumental, leisure and social activities. | Pre-treatment (ideally within 72 hours of baseline), post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke |
| Reintegration to Normal Living Index (RNLI) | To assess quantitatively the degree that individuals who have experienced a traumatic injury or illness come to manage and reintegrate normal social activities with regard to recreation, movement at home and within the community, family and relationships. | Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke |
| Geriatric Depression Scale (GDS-15) | A self-report assessment used to identify depressive symptoms in the elderly. | Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke |
| NIH Stroke Scale (NIHSS) | A systematic assessment used to evaluate and measure stroke-related. neurological impairments and stroke severity. | Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke |
| Short Blessed Orientation and Memory Concentration Test (SBT) | An assessment of cognitive ability and impairment. | Baseline (within 30 days post stroke) |
| Mesulam Symbol Cancellation Test (SCT) | An assessment used to evaluate visuospatial function and attention. | Baseline (within 30 days post stroke) |
| Faces Pain Scale | A self-report measure of pain intensity. | Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke |
| Fugl Meyer Assessment (Upper Extremity) | A performanced-based impairment index to assess motor function, sensation and joint function. | Baseline (within 30 days post stroke) and 1 year post stroke |
| Manual Muscle Test (Upper Extremity) | Muscle strength assessment | Baseline (within 30 days post stroke) |
| Derived |
| Geed S, Feit P, Edwards DF, Dromerick AW. Why Are Stroke Rehabilitation Trial Recruitment Rates in Single Digits? Front Neurol. 2021 Jun 8;12:674237. doi: 10.3389/fneur.2021.674237. eCollection 2021. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002544 | Cerebral Infarction |
| D002561 | Cerebrovascular Disorders |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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