Stroke, Brain Infarction, Brain Ischemia, Cerebral Infarction, Cerebrovascular Disorders
Conditions
Keywords
stroke, hemiparesis, physical therapy, occupational therapy, neurorehabilitation, patient focused, motor learning, motor control, skill acquisition, skill training, motor recovery, task oriented training, task specific training, arm function, hand function, upper extremity, arm therapy, physical rehabilitation, arm rehabilitation, motor function
Brief summary
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.
Detailed description
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.
Interventions
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.
BEHAVIORALDose-Equivalent Usual & Customary Care - DEUCC
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.
BEHAVIORALUsual and Customary Care - UCC
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.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded to treatment allocation
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Impact Scale (SIS) Hand Function Subscale Score. | Baseline to 1 year post-randomization | 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. |
| Wolf Motor Function Test Time | Baseline to 1 year post-randomization | 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. |
| 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) | Baseline to 1 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. |
| Wolf Motor Function Test (WMFT) Log-transformed Time | Baseline to 1 year post-randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) | Baseline to 1 year post-randomization | Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale. |
| Stroke Impact Scale (SIS) Mobility Subscale Score. | Baseline to 1 year post-randomization | 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. |
| Stroke Impact Scale (SIS) ADL/IADL Subscale Score. | Baseline to 1 year post-randomization | 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. |
| National Institute of Health Stroke Scale (NIHSS) | Baseline to 1 year post-randomization | 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. |
| Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box | Baseline to 1 year post-randomization | Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds. |
| Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength | Baseline to 1 year post-randomization | Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization. |
| Arm Muscle Torque Test - Elbow Extensors | Baseline to 1 year post-randomization | 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. |
| Arm Muscle Torque Test - Elbow Flexors | Baseline to 1 year post-randomization | 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. |
| Arm Muscle Torque Test - Shoulder Extensors | Baseline to 1 year post-randomization | 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. |
| Arm Muscle Torque Test - Wrist Extensors | Baseline to 1 year post-randomization | 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. |
| Arm Muscle Torque Test - Wrist Flexors | Baseline to 1 year post-randomization | 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. |
| 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. | Baseline to 1 year post-randomization | 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. |
| Stroke Impact Scale (SIS) Emotion Subscale Score. | Baseline to 1 year post-randomization | 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. |
| Arm Muscle Torque Test - Shoulder Flexors | Baseline to 1 year post-randomization | 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. |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Monthly Telephone Interviews | monthly, beginning 30 days post-randomization | 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. |
| Exit Interview | Post-intervention to 1 year post-randomization | 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 Interview | 16-20 weeks post-randomization | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 119 |
| 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. | 120 |
| 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. | 122 |
| Total | 361 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 6 | 9 |
| Overall Study | Physician Decision | 6 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 10 | 15 |
Baseline characteristics
| Characteristic | UCC Usual & Customary Care | Total | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care |
|---|---|---|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 13.1 | 60.7 years STANDARD_DEVIATION 12.5 | 60.9 years STANDARD_DEVIATION 13.7 | 59.9 years STANDARD_DEVIATION 10.5 |
| Amount of pre-randomization outpatient occupational therapy | 3.7 hours STANDARD_DEVIATION 3.4 | 3.8 hours STANDARD_DEVIATION 3 | 4.4 hours STANDARD_DEVIATION 3.1 | 3.3 hours STANDARD_DEVIATION 2.3 |
| Concordance Concordant | 57 participants | 176 participants | 55 participants | 64 participants |
| Concordance Discordant | 65 participants | 185 participants | 64 participants | 56 participants |
| Education Completed bachelor's degree | 23 participants | 71 participants | 22 participants | 26 participants |
| Education Completed doctoral degree | 8 participants | 20 participants | 6 participants | 6 participants |
| Education Completed high school | 27 participants | 72 participants | 24 participants | 21 participants |
| Education Completed master's degree | 7 participants | 33 participants | 15 participants | 11 participants |
| Education Less than high school | 2 participants | 8 participants | 4 participants | 2 participants |
| Education Some college | 46 participants | 130 participants | 42 participants | 42 participants |
| Education Some high school | 8 participants | 26 participants | 6 participants | 12 participants |
| Education Unknown or Not Reported | 1 participants | 1 participants | 0 participants | 0 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 36 Participants | 9 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 107 Participants | 320 Participants | 107 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants | 0 Participants |
| Language English | 121 participants | 357 participants | 117 participants | 119 participants |
| Language Spanish | 1 participants | 4 participants | 2 participants | 1 participants |
| Pre-randomization outpatient occupational therapy | 42 participants | 105 participants | 34 participants | 29 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 19 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 54 Participants | 151 Participants | 47 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 7 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 7 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 48 Participants | 15 Participants | 15 Participants |
| Race (NIH/OMB) White | 43 Participants | 124 Participants | 38 Participants | 43 Participants |
| Referral source Acute care | 19 participants | 66 participants | 21 participants | 26 participants |
| Referral source Inpatient rehabilitation | 88 participants | 247 participants | 80 participants | 79 participants |
| Referral source Open referral | 8 participants | 24 participants | 9 participants | 7 participants |
| Referral source Other | 0 participants | 1 participants | 0 participants | 1 participants |
| Referral source Outpatient | 5 participants | 16 participants | 6 participants | 5 participants |
| Referral source Transitional day program | 2 participants | 7 participants | 3 participants | 2 participants |
| Region of Enrollment United States | 122 participants | 361 participants | 119 participants | 120 participants |
| Sex: Female, Male Female | 50 Participants | 158 Participants | 55 Participants | 53 Participants |
| Sex: Female, Male Male | 72 Participants | 203 Participants | 64 Participants | 67 Participants |
| Side of hemiparesis Left | 65 participants | 193 participants | 68 participants | 60 participants |
| Side of hemiparesis Right | 57 participants | 168 participants | 51 participants | 60 participants |
| Strata High severity, early onset | 25 participants | 70 participants | 23 participants | 22 participants |
| Strata High severity, late onset | 12 participants | 36 participants | 12 participants | 12 participants |
| Strata Low severity, early onset | 67 participants | 205 participants | 68 participants | 70 participants |
| Strata Low severity, late onset | 18 participants | 50 participants | 16 participants | 16 participants |
| Stroke location Brain stem | 9 participants | 25 participants | 11 participants | 5 participants |
| Stroke location Cerebellum | 0 participants | 1 participants | 0 participants | 1 participants |
| Stroke location Left hemisphere | 50 participants | 154 participants | 49 participants | 55 participants |
| Stroke location Other | 3 participants | 8 participants | 2 participants | 3 participants |
| Stroke location Right hemisphere | 60 participants | 173 participants | 57 participants | 56 participants |
| Stroke severity National Institutes of Health Stroke Scale score | 3.7 units on a scale STANDARD_DEVIATION 1.7 | 3.6 units on a scale STANDARD_DEVIATION 1.8 | 3.6 units on a scale STANDARD_DEVIATION 2 | 3.4 units on a scale STANDARD_DEVIATION 1.7 |
| Stroke severity Upper Extremity Motor Fugl-Meyer score | 41.6 units on a scale STANDARD_DEVIATION 9.5 | 41.6 units on a scale STANDARD_DEVIATION 9.4 | 41.7 units on a scale STANDARD_DEVIATION 9.5 | 41.5 units on a scale STANDARD_DEVIATION 9.2 |
| Stroke type Intraparenchymal hemorrhagic | 15 participants | 43 participants | 16 participants | 12 participants |
| Stroke type Ischemic with hemorrhagic conversion | 4 participants | 11 participants | 3 participants | 4 participants |
| Stroke type Ischemic without hemorrhagic conversion | 101 participants | 299 participants | 100 participants | 98 participants |
| Stroke type Other | 1 participants | 6 participants | 0 participants | 5 participants |
| Stroke type Unknown or Not Reported | 1 participants | 2 participants | 0 participants | 1 participants |
| Time from stroke to randomization | 47.0 days STANDARD_DEVIATION 23.9 | 45.8 days STANDARD_DEVIATION 22.4 | 45.2 days STANDARD_DEVIATION 20.3 | 45.0 days STANDARD_DEVIATION 22.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 67 / 119 | 69 / 120 | 55 / 122 | 1 / 772 |
| serious Total, serious adverse events | 37 / 119 | 36 / 120 | 32 / 122 | 4 / 772 |
Outcome results
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ASAP Accelerated Skill Acquisition Program | 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) | 72.7 percentage of participants |
| DEUCC Dose-Equivalent Usual & Customary Care | 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) | 72.1 percentage of participants |
| UCC Usual & Customary Care | 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) | 68.7 percentage of participants |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Stroke Impact Scale (SIS) Hand Function Subscale Score. | 37.6 units on a scale |
| DEUCC Dose-Equivalent Usual & Customary Care | Stroke Impact Scale (SIS) Hand Function Subscale Score. | 35.7 units on a scale |
| UCC Usual & Customary Care | Stroke Impact Scale (SIS) Hand Function Subscale Score. | 37.1 units on a scale |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Wolf Motor Function Test Time | -8.1 seconds |
| DEUCC Dose-Equivalent Usual & Customary Care | Wolf Motor Function Test Time | -8.7 seconds |
| UCC Usual & Customary Care | Wolf Motor Function Test Time | -7.5 seconds |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Wolf Motor Function Test (WMFT) Log-transformed Time | -0.8 log(seconds) |
| DEUCC Dose-Equivalent Usual & Customary Care | Wolf Motor Function Test (WMFT) Log-transformed Time | -0.9 log(seconds) |
| UCC Usual & Customary Care | Wolf Motor Function Test (WMFT) Log-transformed Time | -0.8 log(seconds) |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Arm Muscle Torque Test - Elbow Extensors | 20.0 kilograms | Standard Deviation 47.33 |
| DEUCC Dose-Equivalent Usual & Customary Care | Arm Muscle Torque Test - Elbow Extensors | 15.73 kilograms | Standard Deviation 48.1 |
| UCC Usual & Customary Care | Arm Muscle Torque Test - Elbow Extensors | 14.58 kilograms | Standard Deviation 50.28 |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Arm Muscle Torque Test - Elbow Flexors | 30.41 kilograms | Standard Deviation 52.03 |
| DEUCC Dose-Equivalent Usual & Customary Care | Arm Muscle Torque Test - Elbow Flexors | 20.78 kilograms | Standard Deviation 56.39 |
| UCC Usual & Customary Care | Arm Muscle Torque Test - Elbow Flexors | 24.21 kilograms | Standard Deviation 45.13 |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Arm Muscle Torque Test - Shoulder Extensors | 25.61 kilograms | Standard Deviation 56.63 |
| DEUCC Dose-Equivalent Usual & Customary Care | Arm Muscle Torque Test - Shoulder Extensors | 20.76 kilograms | Standard Deviation 55.23 |
| UCC Usual & Customary Care | Arm Muscle Torque Test - Shoulder Extensors | 18.64 kilograms | Standard Deviation 59.04 |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Arm Muscle Torque Test - Shoulder Flexors | 21.41 kilograms | Standard Deviation 57.12 |
| DEUCC Dose-Equivalent Usual & Customary Care | Arm Muscle Torque Test - Shoulder Flexors | 24.4 kilograms | Standard Deviation 51.9 |
| UCC Usual & Customary Care | Arm Muscle Torque Test - Shoulder Flexors | 19.74 kilograms | Standard Deviation 47.86 |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Arm Muscle Torque Test - Wrist Extensors | 15.19 kilograms | Standard Deviation 37.59 |
| DEUCC Dose-Equivalent Usual & Customary Care | Arm Muscle Torque Test - Wrist Extensors | 18.07 kilograms | Standard Deviation 34.03 |
| UCC Usual & Customary Care | Arm Muscle Torque Test - Wrist Extensors | 18.12 kilograms | Standard Deviation 32.07 |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Arm Muscle Torque Test - Wrist Flexors | 16.24 kilograms | Standard Deviation 39.37 |
| DEUCC Dose-Equivalent Usual & Customary Care | Arm Muscle Torque Test - Wrist Flexors | 10.71 kilograms | Standard Deviation 30.21 |
| UCC Usual & Customary Care | Arm Muscle Torque Test - Wrist Flexors | 8.96 kilograms | Standard Deviation 28.76 |
Secondary
As-Tex Sensory Index
Time frame: Baseline to 1 year post-randomization
Secondary
Color Trails Making Tests 1 & 2
Time frame: Baseline to 1 year post-randomization
Secondary
Confidence in Arm & Hand Movement (CAHM)
Time frame: Baseline to 1 year post-randomization
Secondary
Digits Span Backward
Time frame: Baseline to 1 year post-randomization
Secondary
D-KEFS Verbal Fluency Test
Time frame: Baseline to 1 year post-randomization
Secondary
EQ5D
Time frame: Baseline to 1 year post-randomization
Secondary
Hopkins Verbal Learning Test, Revised (HVLT-R)
Time frame: Baseline to 1 year post-randomization
Secondary
Motor Activity Log 28 QOM (MAL-28)
Time frame: 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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | National Institute of Health Stroke Scale (NIHSS) | -1.67 score on a scale | Standard Deviation 2.28 |
| DEUCC Dose-Equivalent Usual & Customary Care | National Institute of Health Stroke Scale (NIHSS) | -1.61 score on a scale | Standard Deviation 1.79 |
| UCC Usual & Customary Care | National Institute of Health Stroke Scale (NIHSS) | -1.76 score on a scale | Standard Deviation 1.7 |
Secondary
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline to 1 year post-randomization
Secondary
Reintegration to Normal Living Index (RNLI)
Time frame: Baseline to 1 year post-randomization
Secondary
Satisfaction With Life Scale (SWLS)
Time frame: Baseline to 1 year post-randomization
Secondary
Short Blessed Memory Test
Time frame: Baseline to 1 year post-randomization
Secondary
Single-Item Subjective Quality of Life Measurement (SQOL)
Time frame: 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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Stroke Impact Scale (SIS) ADL/IADL Subscale Score. | 22.69 units on a scale | Standard Deviation 20.33 |
| DEUCC Dose-Equivalent Usual & Customary Care | Stroke Impact Scale (SIS) ADL/IADL Subscale Score. | 21.53 units on a scale | Standard Deviation 18.76 |
| UCC Usual & Customary Care | Stroke Impact Scale (SIS) ADL/IADL Subscale Score. | 23.22 units on a scale | Standard Deviation 18.88 |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Stroke Impact Scale (SIS) Communication Subscale Score. | 6.23 units on a scale | Standard Deviation 17.38 |
| DEUCC Dose-Equivalent Usual & Customary Care | Stroke Impact Scale (SIS) Communication Subscale Score. | 2.97 units on a scale | Standard Deviation 14.67 |
| UCC Usual & Customary Care | Stroke Impact Scale (SIS) Communication Subscale Score. | 3.11 units on a scale | Standard Deviation 13.05 |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Stroke Impact Scale (SIS) Emotion Subscale Score. | 3.49 units on a scale | Standard Deviation 17.81 |
| DEUCC Dose-Equivalent Usual & Customary Care | Stroke Impact Scale (SIS) Emotion Subscale Score. | 3.63 units on a scale | Standard Deviation 17.21 |
| UCC Usual & Customary Care | Stroke Impact Scale (SIS) Emotion Subscale Score. | 3.36 units on a scale | Standard Deviation 15.52 |
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.
Time frame: Baseline to 1 year post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | Stroke Impact Scale (SIS) Mobility Subscale Score. | 11.22 units on a scale | Standard Deviation 22.53 |
| DEUCC Dose-Equivalent Usual & Customary Care | Stroke Impact Scale (SIS) Mobility Subscale Score. | 12.08 units on a scale | Standard Deviation 21.15 |
| UCC Usual & Customary Care | Stroke Impact Scale (SIS) Mobility Subscale Score. | 14.91 units on a scale | Standard Deviation 22.6 |
Secondary
Upper Extremity Fugl Meyer (UEFM), Motor Component
Time frame: 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.
Time frame: Baseline to 1 year post-randomization
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.
Time frame: 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.
Time frame: Baseline to 1 year post-randomization
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.
Time frame: Post-intervention to 1 year post-randomization
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.
Time frame: monthly, beginning 30 days post-randomization
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.
Time frame: 16-20 weeks post-randomization