An interventional study of Accelerated Skill Acquisition Program (ASAP) and Dose-Equivalent Usual & Customary Care - DEUCC in Stroke, Brain Infarction and Brain Ischemia, sponsored by University of Southern California. Completed at 8 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-07-09.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
219 studies on the registry are indexed under Cerebral Infarction; 46 are open to participants now.
This study's enrollment of 361 is above the median of 120 across 139 interventional studies indexed under Cerebral Infarction.
Browse Cerebral Infarction studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
Compared within Cerebral Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
Behavioral: Accelerated Skill Acquisition Program (ASAP)
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.
Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC
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.
Behavioral: Usual and Customary Care - UCC
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.
Also known as: ASAP
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.
Also known as: DEUCC
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.
Also known as: UCC
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
As-Tex Sensory Index
Time frame: Baseline to 1 year post-randomization
Upper Extremity Fugl Meyer (UEFM), Motor Component
Time frame: Baseline to 1 year post-randomization
D-KEFS Verbal Fluency Test
Time frame: Baseline to 1 year post-randomization
Digits Span Backward
Time frame: Baseline to 1 year post-randomization
Hopkins Verbal Learning Test, Revised (HVLT-R)
Time frame: Baseline to 1 year post-randomization
Color Trails Making Tests 1 & 2
Time frame: Baseline to 1 year post-randomization
Short Blessed Memory Test
Time frame: Baseline to 1 year post-randomization
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline to 1 year post-randomization
Confidence in Arm & Hand Movement (CAHM)
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 1 year post-randomization
Motor Activity Log 28 QOM (MAL-28)
Time frame: Baseline to 1 year post-randomization
EQ5D
Time frame: Baseline to 1 year post-randomization
Satisfaction With Life Scale (SWLS)
Time frame: Baseline to 1 year post-randomization
Single-Item Subjective Quality of Life Measurement (SQOL)
Time frame: Baseline to 1 year post-randomization
Reintegration to Normal Living Index (RNLI)
Time frame: Baseline to 1 year post-randomization
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
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
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
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.
| Milestone | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Started | 119 | 120 | 122 |
| Post-intervention | 112 | 115 | 115 |
| 6-mo follow-up | 110 | 113 | 112 |
| Completed | 104 | 104 | 96 |
| Not completed | 15 | 16 | 26 |
| Withdrew: Withdrawal by subject | 6 | 10 | 15 |
| Withdrew: Physician decision | 6 | 0 | 2 |
| Withdrew: Lost to follow-up | 3 | 6 | 9 |
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.
| log(seconds) | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Wolf Motor Function Test (WMFT) Log-transformed Time | -0.8 (-1.0 to -0.6) | -0.9 (-1.0 to -0.7) | -0.8 (-1.0 to -0.6) |
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.
| seconds | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Wolf Motor Function Test Time | -8.1 (-11.7 to -4.5) | -8.7 (-11.6 to -5.8) | -7.5 (-10.5 to -4.6) |
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.
| units on a scale | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Stroke Impact Scale (SIS) Hand Function Subscale Score. | 37.6 (31.7 to 43.5) | 35.7 (30.4 to 40.9) | 37.1 (32.2 to 42.1) |
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.
| percentage of participants | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | 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) | 72.7 | 72.1 | 68.7 |
Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale.
Results for this outcome have not been posted.
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.
| units on a scale | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Stroke Impact Scale (SIS) Mobility Subscale Score. | 11.22 ± 22.53 | 12.08 ± 21.15 | 14.91 ± 22.6 |
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.
| units on a scale | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Stroke Impact Scale (SIS) ADL/IADL Subscale Score. | 22.69 ± 20.33 | 21.53 ± 18.76 | 23.22 ± 18.88 |
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.
| score on a scale | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| National Institute of Health Stroke Scale (NIHSS) | -1.67 ± 2.28 | -1.61 ± 1.79 | -1.76 ± 1.7 |
Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds.
Results for this outcome have not been posted.
Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization.
Results for this outcome have not been posted.
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.
| kilograms | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Arm Muscle Torque Test - Elbow Extensors | 20.0 ± 47.33 | 15.73 ± 48.10 | 14.58 ± 50.28 |
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.
| kilograms | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Arm Muscle Torque Test - Elbow Flexors | 30.41 ± 52.03 | 20.78 ± 56.39 | 24.21 ± 45.13 |
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.
| kilograms | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Arm Muscle Torque Test - Shoulder Extensors | 25.61 ± 56.63 | 20.76 ± 55.23 | 18.64 ± 59.04 |
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.
| kilograms | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Arm Muscle Torque Test - Shoulder Flexors | 21.41 ± 57.12 | 24.4 ± 51.90 | 19.74 ± 47.86 |
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.
| kilograms | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Arm Muscle Torque Test - Wrist Extensors | 15.19 ± 37.59 | 18.07 ± 34.03 | 18.12 ± 32.07 |
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.
| kilograms | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Arm Muscle Torque Test - Wrist Flexors | 16.24 ± 39.37 | 10.71 ± 30.21 | 8.96 ± 28.76 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
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.
| units on a scale | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Stroke Impact Scale (SIS) Communication Subscale Score. | 6.23 ± 17.38 | 2.97 ± 14.67 | 3.11 ± 13.05 |
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.
| units on a scale | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care |
|---|---|---|---|
| Stroke Impact Scale (SIS) Emotion Subscale Score. | 3.49 ± 17.81 | 3.63 ± 17.21 | 3.36 ± 15.52 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ASAP Accelerated Skill Acquisition Program | — | 37/119 (31.1%) | 67/119 (56.3%) |
| DEUCC Dose-Equivalent Usual & Customary Care | — | 36/120 (30%) | 69/120 (57.5%) |
| UCC Usual & Customary Care | — | 32/122 (26.2%) | 55/122 (45.1%) |
| Screened But Not Randomized | — | 4/772 (0.5%) | 1/772 (0.1%) |
| Event | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care | Screened But Not Randomized |
|---|---|---|---|---|
| Inpatient Hospitalization or ER visit >23 hoursGeneral disorders | 28/119 | 32/120 | 28/122 | 4/772 |
| Recurrent Stroke or TIANervous system disorders | 13/119 | 9/120 | 7/122 | 2/772 |
| FractureMusculoskeletal and connective tissue disorders | 5/119 | 5/120 | 6/122 | 0/772 |
| MI or Acute Coronary SyndromeCardiac disorders | 1/119 | 3/120 | 4/122 | 0/772 |
| Excessive blood pressure responseVascular disorders | 1/119 | 1/120 | 3/122 | 1/772 |
| New onset of Cardiac ArrhythmiaCardiac disorders | 2/119 | 1/120 | 2/122 | 0/772 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/119 | 0/120 | 2/122 | 0/772 |
| Unexpected/OtherGeneral disorders | 2/119 | 1/120 | 0/122 | 1/772 |
| DeathGeneral disorders | 1/119 | 1/120 | 2/122 | 0/772 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 0/119 | 0/120 | 0/122 | 0/772 |
| Event | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care | Screened But Not Randomized |
|---|---|---|---|---|
| Fall with No FractureGeneral disorders | 41/119 | 32/120 | 23/122 | 0/772 |
| Muscle soreness or pain that persists for more than 48 hoursMusculoskeletal and connective tissue disorders | 29/119 | 27/120 | 29/122 | 0/772 |
| Shoulder pain that limits study participationMusculoskeletal and connective tissue disorders | 16/119 | 17/120 | 20/122 | 0/772 |
| Excessive blood pressure responseVascular disorders | 15/119 | 15/120 | 3/122 | 1/772 |
| Open sore or cutsSkin and subcutaneous tissue disorders | 8/119 | 13/120 | 4/122 | 0/772 |
| Dizziness/FaintingGeneral disorders | 10/119 | 13/120 | 9/122 | 0/772 |
| Unexpected SAEsGeneral disorders | 10/119 | 12/120 | 7/122 | 0/772 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 4/119 | 6/120 | 3/122 | 0/772 |
| Deep Vein ThrombosisVascular disorders | 2/119 | 0/120 | 1/122 | 0/772 |
| Age, Continuous(years) | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care | Total |
|---|---|---|---|---|
| Mean | 60.9 ± 13.7 | 59.9 ± 10.5 | 61.1 ± 13.1 | 60.7 ± 12.5 |
| Sex: Female, Male(Participants) | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care | Total |
|---|---|---|---|---|
| Female | 55 | 53 | 50 | 158 |
| Male | 64 | 67 | 72 | 203 |
| Ethnicity (NIH/OMB)(Participants) | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care | Total |
|---|---|---|---|---|
| Hispanic or Latino | 9 | 14 | 13 | 36 |
| Not Hispanic or Latino | 107 | 106 | 107 | 320 |
| Unknown or Not Reported | 3 | 0 | 2 | 5 |
| Race (NIH/OMB)(Participants) | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 4 | 1 | 0 | 5 |
| Asian | 9 | 7 | 3 | 19 |
| Native Hawaiian or Other Pacific Islander | 3 | 1 | 3 | 7 |
| Black or African American | 47 | 50 | 54 | 151 |
| White | 38 | 43 | 43 | 124 |
| More than one race | 3 | 3 | 1 | 7 |
| Unknown or Not Reported | 15 | 15 | 18 | 48 |
| Region of Enrollment(participants) | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care | Total |
|---|---|---|---|---|
| United States | 119 | 120 | 122 | 361 |
| Education(participants) | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care | Total |
|---|---|---|---|---|
| Less than high school | 4 | 2 | 2 | 8 |
| Some high school | 6 | 12 | 8 | 26 |
| Completed high school | 24 | 21 | 27 | 72 |
| Some college | 42 | 42 | 46 | 130 |
| Completed bachelor's degree | 22 | 26 | 23 | 71 |
| Completed master's degree | 15 | 11 | 7 | 33 |
| Completed doctoral degree | 6 | 6 | 8 | 20 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Referral source(participants) | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care | Total |
|---|---|---|---|---|
| Inpatient rehabilitation | 80 | 79 | 88 | 247 |
| Outpatient | 6 | 5 | 5 | 16 |
| Acute care | 21 | 26 | 19 | 66 |
| Transitional day program | 3 | 2 | 2 | 7 |
| Open referral | 9 | 7 | 8 | 24 |
| Other | 0 | 1 | 0 | 1 |
| Language(participants) | ASAP Accelerated Skill Acquisition Program | DEUCC Dose-Equivalent Usual & Customary Care | UCC Usual & Customary Care | Total |
|---|---|---|---|---|
| English | 117 | 119 | 121 | 357 |
| Spanish | 2 | 1 | 1 | 4 |
9 further baseline measures are reported on the registry.
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