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| ID | Type | Description | Link |
|---|---|---|---|
| U01NS056256 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study is about arm and hand recovery after a stroke. The investigators are testing an experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice compared to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual and customary arm therapy for a duration indicated on the therapy prescription). A second objective is to characterize current outpatient arm therapy (dosage & content) following stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke affecting an arm within the last 106 days.
Of the 700,000 individuals who experience a new or recurrent stroke each year, a majority have considerable residual disability. Sixty-five percent (65%) of patients at 6 months are unable to incorporate the paretic hand effectively into daily activities. In turn, this degree of functional deficit contributes to a reduced quality of life after stroke. The extent of disability has been underplayed by the use of the Barthel Index that captures only basic activities of daily living such as self-care and does not extend to activities and participation at higher levels of functioning that are most affected by a residual upper extremity disability. The past decade has witnessed an explosion of different therapy interventions designed to capitalize on the brain's inherent capability to rewire and learn well into old age and more importantly for rehabilitation, after injury. The most effective arm-focused interventions with the strongest evidence and potentially the most immediate and cost-effective appeal for the current health-care environment share a common emphasis on focused task-specific training applied with an intensity higher than usual care. Therefore, our primary aim is to compare the efficacy of a fully defined, hybrid combination of the most effective interventions (forced-use/constraint-induced therapy and skill-based/impairment-mitigating motor learning training), the Accelerated Skill Acquisition Program (ASAP), to an equivalent dose of usual and customary outpatient therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASAP | Experimental | A focused, intense, evidence-based, upper extremity rehabilitation program, administered during the early post-acute outpatient interval. 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. |
|
| DEUCC | Active Comparator | Dose-equivalent usual and customary arm therapy administered early post-acutely in the outpatient setting. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
|
| UCC | Other | Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group with treatment dose administered in accordance with usual and customary practices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated Skill Acquisition Program (ASAP) | Behavioral | A 30-hour dose is administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session precedes the first visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test (WMFT) Log-transformed Time | Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity. | Baseline to 1 year post-randomization |
| Wolf Motor Function Test Time | Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity. | Baseline to 1 year post-randomization |
| Stroke Impact Scale (SIS) Hand Function Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of hand function. | Baseline to 1 year post-randomization |
| Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization) | The available range for improvement is from 0-100; thus participants with a baseline SIS score greater than 75 (n=15) were excluded from these analyses. | Baseline to 1 year post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) | Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale. | Baseline to 1 year post-randomization |
| Stroke Impact Scale (SIS) Mobility Subscale Score. |
| Measure | Description | Time Frame |
|---|---|---|
| Monthly Telephone Interviews | A monthly telephone interview with the participant to ascertain information about health status, healthcare utilization, medications, other therapies, and adverse events. Some of these data are reported in the adverse event section. Other data (e.g. those related to healthcare utilization) are part of the secondary analyses presently underway. Until published, these are embargoed information. Once published, these data will be made available via ClinicalTrials.gov. |
INCLUSION
Ischemic or hemorrhagic stroke.
Hemiparesis in an upper extremity.
Age 21+.
Able to communicate in English (or Spanish,Rancho Los Amigos site only).
Willing to attend outpatient therapy & f/u evaluations for 1 yr.
Some active finger extension.
EXCLUSION
Traumatic or non-vascular brain injury, subarachnoid hemorrhage, AV malformation.
History of psychiatric illness requiring hospitalization within past 24 mos.
Active drug treatment for dementia.
Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS).
History of head trauma requiring >48 hours of hospitalization within past 12 mos.
Amputation of all fingers or thumb of hemiparetic (weak) arm.
Treated with Botox in affected arm within last 3 months.
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| Name | Affiliation | Role |
|---|---|---|
| Carolee J. Winstein, PhD, PT | University of Southern California | Principal Investigator |
| Alexander Dromerick, MD | MedStar National Rehabilitation Network | Principal Investigator |
| Steven Wolf, PhD, PT | Emory University | Principal Investigator |
| Monica A Nelsen, DPT, PT | University of Southern California | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23311856 | Background | Winstein CJ, Wolf SL, Dromerick AW, Lane CJ, Nelsen MA, Lewthwaite R, Blanton S, Scott C, Reiss A, Cen SY, Holley R, Azen SP; ICARE Investigative Team. Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol. BMC Neurol. 2013 Jan 11;13:5. doi: 10.1186/1471-2377-13-5. | |
| 25323459 | Background | Duff SV, He J, Nelsen MA, Lane CJ, Rowe VT, Wolf SL, Dromerick AW, Winstein CJ. Interrater reliability of the Wolf Motor Function Test-Functional Ability Scale: why it matters. Neurorehabil Neural Repair. 2015 Jun;29(5):436-43. doi: 10.1177/1545968314553030. Epub 2014 Oct 16. |
| Label | URL |
|---|---|
| ICARE Administrative Headquarters: USC Department of Biokinesiology \& Physical Therapy | View source |
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From June 2009 through February 2013, 11,051 patients were pre-screened (medical record review) followed by 772 in-person screening assessments. Through both processes, 9,219 were excluded because they did not meet eligibility criteria; 645 declined and 826 were excluded for other reasons.
Participants were recruited between 5 and 106 days post-stroke, predominantly during inpatient rehabilitation, from 7 sites in the United States metropolitan areas of Los Angeles, CA, Atlanta, GA and Washington, D.C.
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| ID | Title | Description |
|---|---|---|
| FG000 | ASAP Accelerated Skill Acquisition Program | A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Blinded to treatment allocation
|
| Dose-Equivalent Usual & Customary Care - DEUCC | Behavioral | Usual and customary arm therapy administered early post-acutely in the outpatient setting, adjusted for dose, but otherwise administered in accordance with usual and customary practices. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
|
|
| Usual and Customary Care - UCC | Behavioral | Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group and treatment dose will be administered in accordance with usual and customary practices. |
|
|
Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of mobility. |
| Baseline to 1 year post-randomization |
| Stroke Impact Scale (SIS) ADL/IADL Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of ease with activities queried. | Baseline to 1 year post-randomization |
| National Institute of Health Stroke Scale (NIHSS) | Change from baseline to end-of-study (12 months post-randomization) in National Institute of Health Stroke Scale (NIHSS). Range 0-2. Lower scores indicate less stroke severity. | Baseline to 1 year post-randomization |
| Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box | Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds. | Baseline to 1 year post-randomization |
| Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength | Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization. | Baseline to 1 year post-randomization |
| Arm Muscle Torque Test - Elbow Extensors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions.Positive values indicate a strength gain. | Baseline to 1 year post-randomization |
| Arm Muscle Torque Test - Elbow Flexors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Baseline to 1 year post-randomization |
| Arm Muscle Torque Test - Shoulder Extensors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Baseline to 1 year post-randomization |
| Arm Muscle Torque Test - Shoulder Flexors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Baseline to 1 year post-randomization |
| Arm Muscle Torque Test - Wrist Extensors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Baseline to 1 year post-randomization |
| Arm Muscle Torque Test - Wrist Flexors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Baseline to 1 year post-randomization |
| As-Tex Sensory Index | Baseline to 1 year post-randomization |
| Upper Extremity Fugl Meyer (UEFM), Motor Component | Baseline to 1 year post-randomization |
| D-KEFS Verbal Fluency Test | Baseline to 1 year post-randomization |
| Digits Span Backward | Baseline to 1 year post-randomization |
| Hopkins Verbal Learning Test, Revised (HVLT-R) | Baseline to 1 year post-randomization |
| Color Trails Making Tests 1 & 2 | Baseline to 1 year post-randomization |
| Short Blessed Memory Test | Baseline to 1 year post-randomization |
| Patient Health Questionnaire 9 (PHQ-9) | Baseline to 1 year post-randomization |
| Confidence in Arm & Hand Movement (CAHM) | Baseline to 1 year post-randomization |
| Stroke Impact Scale (SIS) Communication Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of ability to communicate and comprehend. | Baseline to 1 year post-randomization |
| Stroke Impact Scale (SIS) Emotion Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of mood and emotional control. | Baseline to 1 year post-randomization |
| Motor Activity Log 28 QOM (MAL-28) | Baseline to 1 year post-randomization |
| EQ5D | Baseline to 1 year post-randomization |
| Satisfaction With Life Scale (SWLS) | Baseline to 1 year post-randomization |
| Single-Item Subjective Quality of Life Measurement (SQOL) | Baseline to 1 year post-randomization |
| Reintegration to Normal Living Index (RNLI) | Baseline to 1 year post-randomization |
| monthly, beginning 30 days post-randomization |
| Post-Intervention Interview | A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions to assess the extent to which critical components of the investigational intervention (e.g. impairment mitigation, session intensity, participant chosen tasks, therapist-participant collaboration) were incorporated into each assigned therapy group. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov. | 16-20 weeks post-randomization |
| Exit Interview | A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions regarding activity since the end of the intervention phase. Participants were also asked to report the perceived value of the intervention and study participation. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov. | Post-intervention to 1 year post-randomization |
| Los Angeles |
| California |
| 90048 |
| United States |
| Rancho Los Amigos National Rehabilitation Center | Los Angeles | California | 90242 | United States |
| Long Beach Memorial Medical Center | Los Angeles | California | 90806 | United States |
| Huntington Rehabilitation Medicine Associates | Los Angeles | California | 91105 | United States |
| Casa Colina Centers for Rehabilitation | Los Angeles | California | 91769 | United States |
| National Rehabilitation Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| 26864411 | Result | Winstein CJ, Wolf SL, Dromerick AW, Lane CJ, Nelsen MA, Lewthwaite R, Cen SY, Azen SP; Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Investigative Team. Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):571-81. doi: 10.1001/jama.2016.0276. |
| 32433993 | Derived | Martinez C, Bacon H, Rowe V, Russak D, Fitzgerald E, Woodbury M, Wolf SL, Winstein C. A Reaching Performance Scale for 2 Wolf Motor Function Test Items. Arch Phys Med Rehabil. 2020 Nov;101(11):2015-2026. doi: 10.1016/j.apmr.2020.05.003. Epub 2020 May 17. |
| 29554849 | Derived | Lewthwaite R, Winstein CJ, Lane CJ, Blanton S, Wagenheim BR, Nelsen MA, Dromerick AW, Wolf SL. Accelerating Stroke Recovery: Body Structures and Functions, Activities, Participation, and Quality of Life Outcomes From a Large Rehabilitation Trial. Neurorehabil Neural Repair. 2018 Feb;32(2):150-165. doi: 10.1177/1545968318760726. |
| 28434819 | Derived | Rowe VT, Winstein CJ, Wolf SL, Woodbury ML. Functional Test of the Hemiparetic Upper Extremity: A Rasch Analysis With Theoretical Implications. Arch Phys Med Rehabil. 2017 Oct;98(10):1977-1983. doi: 10.1016/j.apmr.2017.03.021. Epub 2017 Apr 21. |
| ICARE Clinical Site: Casa Colina Rehabilitation Centers | View source |
| ICARE Clinical Center: National Rehabilitation Hospital | View source |
| ICARE Clinical Site: Huntington Rehabilitation Medical Associates | View source |
| ICARE Clinical Site: Rancho Los Amigos National Rehabilitation Center | View source |
| ICARE Clinical Center: Emory University | View source |
| ICARE Clinical Site: Long Beach Memorial Medical Center | View source |
| ICARE Clinical Site: Cedars Sinai Medical Center | View source |
| FG001 | DEUCC Dose-Equivalent Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| FG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
| Post-Intervention |
|
| 6-mo Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ASAP Accelerated Skill Acquisition Program | A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit. |
| BG001 | DEUCC Dose-Equivalent Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| BG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Self-selected from categories determined in 1997 by the U.S. Office of Management and Budget in accordance with sponsor mandate. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Self-selected from categories determined in 1997 by the U.S. Office of Management and Budget in accordance with sponsor mandate. For this self-selected measure, 35 participants (9 ASAP, 12 DEUCC, 14 UCC) specified other categories to identify their race. Since an "Other" field is not available, these 35 are included in the count under "Unknown or Not reported" | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Education | Highest level of education completed (self-reported) | Number | participants |
| |||||||||||||||
| Referral source | Setting in which participant was first prospectively identified. | Number | participants |
| |||||||||||||||
| Language | Number | participants |
| ||||||||||||||||
| Time from stroke to randomization | Mean | Standard Deviation | days |
| |||||||||||||||
| Stroke type | Number | participants |
| ||||||||||||||||
| Stroke location | Number | participants |
| ||||||||||||||||
| Side of hemiparesis | Number | participants |
| ||||||||||||||||
| Stroke severity | Upper Extremity Motor Fugl Meyer total score range 0-66; eligible range: 19-58. A lower score indicates greater impairment. For stratification purposes: low severity is greater than or equal to 36; high severity is less than 36. National Institutes of Health Stroke Scale total score range 0-42; higher values represent greater severity. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Strata | Severity: Upper extremity motor Fugl-Meyer score eligible range: 19-58 (low severity is greater than 35; high severity is less than 36). Stroke onset, time to randomization: eligible range: 14-106 days (early onset is less than 60 days; late onset is greater than 59 days). | Number | participants |
| |||||||||||||||
| Concordance | Concordant: the paretic limb is the dominant limb. Discordant: the paretic limb is the non-dominant limb. | Number | participants |
| |||||||||||||||
| Pre-randomization outpatient occupational therapy | Number | participants |
| ||||||||||||||||
| Amount of pre-randomization outpatient occupational therapy | Mean | Standard Deviation | hours |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wolf Motor Function Test (WMFT) Log-transformed Time | Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | 95% Confidence Interval | log(seconds) | Baseline to 1 year post-randomization |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Wolf Motor Function Test Time | Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | 95% Confidence Interval | seconds | Baseline to 1 year post-randomization |
| |||||||||||||||||||||||||||||||||
| Primary | Stroke Impact Scale (SIS) Hand Function Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of hand function. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 1 year post-randomization |
| |||||||||||||||||||||||||||||||||
| Primary | Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization) | The available range for improvement is from 0-100; thus participants with a baseline SIS score greater than 75 (n=15) were excluded from these analyses. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Number | percentage of participants | Baseline to 1 year post-randomization |
| ||||||||||||||||||||||||||||||||||
| Secondary | Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) | Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale. | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | ||||||||||||||||||||||||||||||||||||
| Secondary | Stroke Impact Scale (SIS) Mobility Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of mobility. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 1 year post-randomization |
| |||||||||||||||||||||||||||||||||
| Secondary | Stroke Impact Scale (SIS) ADL/IADL Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of ease with activities queried. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 1 year post-randomization |
| |||||||||||||||||||||||||||||||||
| Secondary | National Institute of Health Stroke Scale (NIHSS) | Change from baseline to end-of-study (12 months post-randomization) in National Institute of Health Stroke Scale (NIHSS). Range 0-2. Lower scores indicate less stroke severity. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 1 year post-randomization |
| |||||||||||||||||||||||||||||||||
| Secondary | Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box | Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds. | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | ||||||||||||||||||||||||||||||||||||
| Secondary | Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength | Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization. | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | ||||||||||||||||||||||||||||||||||||
| Secondary | Arm Muscle Torque Test - Elbow Extensors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions.Positive values indicate a strength gain. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | Standard Deviation | kilograms | Baseline to 1 year post-randomization |
| |||||||||||||||||||||||||||||||||
| Secondary | Arm Muscle Torque Test - Elbow Flexors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | Standard Deviation | kilograms | Baseline to 1 year post-randomization |
| |||||||||||||||||||||||||||||||||
| Secondary | Arm Muscle Torque Test - Shoulder Extensors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | Standard Deviation | kilograms | Baseline to 1 year post-randomization |
| |||||||||||||||||||||||||||||||||
| Secondary | Arm Muscle Torque Test - Shoulder Flexors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | Standard Deviation | kilograms | Baseline to 1 year post-randomization |
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| Secondary | Arm Muscle Torque Test - Wrist Extensors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | Standard Deviation | kilograms | Baseline to 1 year post-randomization |
| |||||||||||||||||||||||||||||||||
| Secondary | Arm Muscle Torque Test - Wrist Flexors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | Standard Deviation | kilograms | Baseline to 1 year post-randomization |
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| Secondary | As-Tex Sensory Index | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Upper Extremity Fugl Meyer (UEFM), Motor Component | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | D-KEFS Verbal Fluency Test | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Digits Span Backward | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Hopkins Verbal Learning Test, Revised (HVLT-R) | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Color Trails Making Tests 1 & 2 | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Short Blessed Memory Test | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Patient Health Questionnaire 9 (PHQ-9) | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Confidence in Arm & Hand Movement (CAHM) | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Stroke Impact Scale (SIS) Communication Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of ability to communicate and comprehend. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 1 year post-randomization |
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| Secondary | Stroke Impact Scale (SIS) Emotion Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of mood and emotional control. | Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 1 year post-randomization |
| |||||||||||||||||||||||||||||||||
| Secondary | Motor Activity Log 28 QOM (MAL-28) | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | EQ5D | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Satisfaction With Life Scale (SWLS) | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Single-Item Subjective Quality of Life Measurement (SQOL) | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Reintegration to Normal Living Index (RNLI) | Not Posted | Jul 2019 | Baseline to 1 year post-randomization | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Monthly Telephone Interviews | A monthly telephone interview with the participant to ascertain information about health status, healthcare utilization, medications, other therapies, and adverse events. Some of these data are reported in the adverse event section. Other data (e.g. those related to healthcare utilization) are part of the secondary analyses presently underway. Until published, these are embargoed information. Once published, these data will be made available via ClinicalTrials.gov. | Not Posted | Jul 2019 | monthly, beginning 30 days post-randomization | Participants | ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Post-Intervention Interview | A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions to assess the extent to which critical components of the investigational intervention (e.g. impairment mitigation, session intensity, participant chosen tasks, therapist-participant collaboration) were incorporated into each assigned therapy group. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov. | Not Posted | Jul 2019 | 16-20 weeks post-randomization | Participants | ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exit Interview | A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions regarding activity since the end of the intervention phase. Participants were also asked to report the perceived value of the intervention and study participation. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov. | Not Posted | Jul 2019 | Post-intervention to 1 year post-randomization | Participants |
From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ASAP Accelerated Skill Acquisition Program | A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit. | 37 | 119 | 67 | 119 | ||
| EG001 | DEUCC Dose-Equivalent Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. | 36 | 120 | 69 | 120 | ||
| EG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. | 32 | 122 | 55 | 122 | ||
| EG003 | Screened But Not Randomized | Individuals who consented to an in-person screening assessment for eligibility but were never randomized. | 4 | 772 | 1 | 772 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| ||
| Recurrent Stroke or TIA | Nervous system disorders | Systematic Assessment |
| ||
| MI or Acute Coronary Syndrome | Cardiac disorders | Systematic Assessment |
| ||
| New onset of Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Inpatient Hospitalization or ER visit >23 hours | General disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Excessive blood pressure response | Vascular disorders | Systematic Assessment | Of such severity that it required treatment discontinuation for the day |
| |
| Unexpected/Other | General disorders | Systematic Assessment | A serious adverse event that involves a condition/circumstance other than those expected and thus other than those pre-identified |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall with No Fracture | General disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Open sore or cuts | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Muscle soreness or pain that persists for more than 48 hours | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Shoulder pain that limits study participation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Excessive blood pressure response | Vascular disorders | Systematic Assessment |
| ||
| Dizziness/Fainting | General disorders | Systematic Assessment |
| ||
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Unexpected SAEs | General disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolee Winstein, Principal Investigator | University of Southern California | 3234422903 | winstein@usc.edu |
| 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 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Some high school |
|
| Completed high school |
|
| Some college |
|
| Completed bachelor's degree |
|
| Completed master's degree |
|
| Completed doctoral degree |
|
| Unknown or Not Reported |
|
| Outpatient |
|
| Acute care |
|
| Transitional day program |
|
| Open referral |
|
| Other |
|
| Spanish |
|
| Ischemic with hemorrhagic conversion |
|
| Intraparenchymal hemorrhagic |
|
| Other |
|
| Unknown or Not Reported |
|
| Left hemisphere |
|
| Cerebellum |
|
| Brain stem |
|
| Other |
|
| Left |
|
| National Institutes of Health Stroke Scale score |
|
| Low severity, late onset |
|
| High severity, early onset |
|
| High severity, late onset |
|
| Discordant |
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.
Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|
Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. |
| OG002 | UCC Usual & Customary Care | Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices. |
|
|