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Arm Rehabilitation Study After Stroke (ICARE)

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ClinicalTrials.gov Identifier: NCT00871715
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : April 27, 2016
Last Update Posted : May 11, 2017
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Carolee Winstein, University of Southern California

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stroke
Brain Infarction
Brain Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Interventions Behavioral: Accelerated Skill Acquisition Program (ASAP)
Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC
Behavioral: Usual and Customary Care - UCC
Enrollment 361
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.
Arm/Group Title ASAP Accelerated Skill Acquisition Program DEUCC Dose-Equivalent Usual & Customary Care UCC Usual & Customary Care
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 119 120 122
Post-Intervention 112 115 115
6-mo Follow-up 110 113 112
Completed 104 [1] 104 [1] 96 [1]
Not Completed 15 16 26
Reason Not Completed
Withdrawal by Subject             6             10             15
Physician Decision             6             0             2
Lost to Follow-up             3             6             9
[1]
"Completed" refers to participants who completed the primary outcome, Wolf Motor Function Test.
Arm/Group Title ASAP Accelerated Skill Acquisition Program DEUCC Dose-Equivalent Usual & Customary Care UCC Usual & Customary Care Total
Hide Arm/Group Description

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 119 120 122 361
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants 120 participants 122 participants 361 participants
60.9  (13.7) 59.9  (10.5) 61.1  (13.1) 60.7  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
Female
55
  46.2%
53
  44.2%
50
  41.0%
158
  43.8%
Male
64
  53.8%
67
  55.8%
72
  59.0%
203
  56.2%
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
Hispanic or Latino
9
   7.6%
14
  11.7%
13
  10.7%
36
  10.0%
Not Hispanic or Latino
107
  89.9%
106
  88.3%
107
  87.7%
320
  88.6%
Unknown or Not Reported
3
   2.5%
0
   0.0%
2
   1.6%
5
   1.4%
[1]
Measure Description: Self-selected from categories determined in 1997 by the U.S. Office of Management and Budget in accordance with sponsor mandate.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
American Indian or Alaska Native
4
   3.4%
1
   0.8%
0
   0.0%
5
   1.4%
Asian
9
   7.6%
7
   5.8%
3
   2.5%
19
   5.3%
Native Hawaiian or Other Pacific Islander
3
   2.5%
1
   0.8%
3
   2.5%
7
   1.9%
Black or African American
47
  39.5%
50
  41.7%
54
  44.3%
151
  41.8%
White
38
  31.9%
43
  35.8%
43
  35.2%
124
  34.3%
More than one race
3
   2.5%
3
   2.5%
1
   0.8%
7
   1.9%
Unknown or Not Reported
15
  12.6%
15
  12.5%
18
  14.8%
48
  13.3%
[1]
Measure Description: 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"
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 119 participants 120 participants 122 participants 361 participants
119 120 122 361
Education   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
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
[1]
Measure Description: Highest level of education completed (self-reported)
Referral source   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
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
[1]
Measure Description: Setting in which participant was first prospectively identified.
Language  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
English 117 119 121 357
Spanish 2 1 1 4
Time from stroke to randomization  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 119 participants 120 participants 122 participants 361 participants
45.2  (20.3) 45.0  (22.8) 47.0  (23.9) 45.8  (22.4)
Stroke type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
Ischemic without hemorrhagic conversion 100 98 101 299
Ischemic with hemorrhagic conversion 3 4 4 11
Intraparenchymal hemorrhagic 16 12 15 43
Other 0 5 1 6
Unknown or Not Reported 0 1 1 2
Stroke location  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
Right hemisphere 57 56 60 173
Left hemisphere 49 55 50 154
Cerebellum 0 1 0 1
Brain stem 11 5 9 25
Other 2 3 3 8
Side of hemiparesis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
Right 51 60 57 168
Left 68 60 65 193
Stroke severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 119 participants 120 participants 122 participants 361 participants
Upper Extremity Motor Fugl-Meyer score 41.7  (9.5) 41.5  (9.2) 41.6  (9.5) 41.6  (9.4)
National Institutes of Health Stroke Scale score 3.6  (2.0) 3.4  (1.7) 3.7  (1.7) 3.6  (1.8)
[1]
Measure Description:

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.

Strata   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
Low severity, early onset 68 70 67 205
Low severity, late onset 16 16 18 50
High severity, early onset 23 22 25 70
High severity, late onset 12 12 12 36
[1]
Measure Description:

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).

Concordance   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
Concordant 55 64 57 176
Discordant 64 56 65 185
[1]
Measure Description: Concordant: the paretic limb is the dominant limb. Discordant: the paretic limb is the non-dominant limb.
Pre-randomization outpatient occupational therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 119 participants 120 participants 122 participants 361 participants
34 29 42 105
Amount of pre-randomization outpatient occupational therapy  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 119 participants 120 participants 122 participants 361 participants
4.4  (3.1) 3.3  (2.3) 3.7  (3.4) 3.8  (3.0)
1.Primary Outcome
Title Wolf Motor Function Test (WMFT) Log-transformed Time
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ASAP Accelerated Skill Acquisition Program DEUCC Dose-Equivalent Usual & Customary Care UCC Usual & Customary Care
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 104 104 96
Mean (95% Confidence Interval)
Unit of Measure: log(seconds)
-0.8
(-1.0 to -0.6)
-0.9
(-1.0 to -0.7)
-0.8
(-1.0 to -0.6)
2.Primary Outcome
Title Wolf Motor Function Test Time
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ASAP Accelerated Skill Acquisition Program DEUCC Dose-Equivalent Usual & Customary Care UCC Usual & Customary Care
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 104 104 96
Mean (95% Confidence Interval)
Unit of Measure: seconds
-8.1
(-11.7 to -4.5)
-8.7
(-11.6 to -5.8)
-7.5
(-10.5 to -4.6)
3.Primary Outcome
Title Stroke Impact Scale (SIS) Hand Function Subscale Score.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ASAP Accelerated Skill Acquisition Program DEUCC Dose-Equivalent Usual & Customary Care UCC Usual & Customary Care
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 105 107 101
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
37.6
(31.7 to 43.5)
35.7
(30.4 to 40.9)
37.1
(32.2 to 42.1)
4.Primary Outcome
Title 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)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ASAP Accelerated Skill Acquisition Program DEUCC Dose-Equivalent Usual & Customary Care UCC Usual & Customary Care
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 99 104 99
Measure Type: Number
Unit of Measure: percentage of participants
72.7 72.1 68.7
5.Secondary Outcome
Title National Institute of Health Stroke Scale (NIHSS)
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Arm Muscle Torque Test
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Wolf Motor Function Test (WMFT) Strength Components
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Upper Extremity Fugl Meyer (UEFM), Motor Component
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Patient Health Questionnaire 9 (PHQ-9)
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
10.Secondary Outcome
Title As-Tex Sensory Index
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Motor Activity Log 28 QOM (MAL-28)
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Satisfaction With Life Scale (SWLS)
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Reintegration to Normal Living Index (RNLI)
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Single-Item Subjective Quality of Life Measurement (SQOL)
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
15.Secondary Outcome
Title EQ5D
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Confidence in Arm & Hand Movement (CAHM)
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Short Blessed Memory Test
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
18.Secondary Outcome
Title D-KEFS Verbal Fluency Test
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Hopkins Verbal Learning Test, Revised (HVLT-R)
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Digits Span Backward
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Color Trails Making Tests 1 & 2
Hide Description 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)
Hide Description Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale. 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 Baseline to 1 year post-randomization
Outcome Measure Data Not Reported
23.Other Pre-specified Outcome
Title Monthly Telephone Interviews
Hide Description 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
Outcome Measure Data Not Reported
24.Other Pre-specified Outcome
Title Post-Intervention Interview
Hide Description 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
Outcome Measure Data Not Reported
25.Other Pre-specified Outcome
Title Exit Interview
Hide Description 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
Outcome Measure Data Not Reported
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title ASAP Accelerated Skill Acquisition Program DEUCC Dose-Equivalent Usual & Customary Care UCC Usual & Customary Care Screened But Not Randomized
Hide Arm/Group Description

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.

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.

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.

Individuals who consented to an in-person screening assessment for eligibility but were never randomized.
All-Cause Mortality
ASAP Accelerated Skill Acquisition Program DEUCC Dose-Equivalent Usual & Customary Care UCC Usual & Customary Care Screened But Not Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ASAP Accelerated Skill Acquisition Program DEUCC Dose-Equivalent Usual & Customary Care UCC Usual & Customary Care Screened But Not Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/119 (31.09%)      36/120 (30.00%)      32/122 (26.23%)      4/772 (0.52%)    
Cardiac disorders         
MI or Acute Coronary Syndrome   1/119 (0.84%)  1 3/120 (2.50%)  3 4/122 (3.28%)  6 0/772 (0.00%)  0
New onset of Cardiac Arrhythmia   2/119 (1.68%)  2 1/120 (0.83%)  1 2/122 (1.64%)  2 0/772 (0.00%)  0
General disorders         
Death   1/119 (0.84%)  1 1/120 (0.83%)  1 2/122 (1.64%)  2 0/772 (0.00%)  0
Inpatient Hospitalization or ER visit >23 hours   28/119 (23.53%)  45 32/120 (26.67%)  46 28/122 (22.95%)  48 4/772 (0.52%)  4
Unexpected/Other  [1]  2/119 (1.68%)  2 1/120 (0.83%)  1 0/122 (0.00%)  0 1/772 (0.13%)  1
Musculoskeletal and connective tissue disorders         
Fracture   5/119 (4.20%)  6 5/120 (4.17%)  5 6/122 (4.92%)  6 0/772 (0.00%)  0
Nervous system disorders         
Recurrent Stroke or TIA   13/119 (10.92%)  18 9/120 (7.50%)  13 7/122 (5.74%)  9 2/772 (0.26%)  2
Respiratory, thoracic and mediastinal disorders         
Pulmonary Embolism   0/119 (0.00%)  0 0/120 (0.00%)  0 0/122 (0.00%)  0 0/772 (0.00%)  0
Dyspnea   2/119 (1.68%)  2 0/120 (0.00%)  0 2/122 (1.64%)  2 0/772 (0.00%)  0
Vascular disorders         
Excessive blood pressure response  [2]  1/119 (0.84%)  1 1/120 (0.83%)  1 3/122 (2.46%)  3 1/772 (0.13%)  1
Indicates events were collected by systematic assessment
[1]
A serious adverse event that involves a condition/circumstance other than those expected and thus other than those pre-identified
[2]
Of such severity that it required treatment discontinuation for the day
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ASAP Accelerated Skill Acquisition Program DEUCC Dose-Equivalent Usual & Customary Care UCC Usual & Customary Care Screened But Not Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/119 (56.30%)      69/120 (57.50%)      55/122 (45.08%)      1/772 (0.13%)    
General disorders         
Fall with No Fracture   41/119 (34.45%)  67 32/120 (26.67%)  41 23/122 (18.85%)  28 0/772 (0.00%)  0
Dizziness/Fainting   10/119 (8.40%)  12 13/120 (10.83%)  14 9/122 (7.38%)  10 0/772 (0.00%)  0
Unexpected SAEs   10/119 (8.40%)  11 12/120 (10.00%)  12 7/122 (5.74%)  8 0/772 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Muscle soreness or pain that persists for more than 48 hours   29/119 (24.37%)  53 27/120 (22.50%)  29 29/122 (23.77%)  38 0/772 (0.00%)  0
Shoulder pain that limits study participation   16/119 (13.45%)  24 17/120 (14.17%)  19 20/122 (16.39%)  27 0/772 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnea   4/119 (3.36%)  7 6/120 (5.00%)  6 3/122 (2.46%)  5 0/772 (0.00%)  0
Skin and subcutaneous tissue disorders         
Open sore or cuts   8/119 (6.72%)  10 13/120 (10.83%)  15 4/122 (3.28%)  6 0/772 (0.00%)  0
Vascular disorders         
Excessive blood pressure response   15/119 (12.61%)  30 15/120 (12.50%)  18 3/122 (2.46%)  4 1/772 (0.13%)  1
Deep Vein Thrombosis   2/119 (1.68%)  2 0/120 (0.00%)  0 1/122 (0.82%)  1 0/772 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Carolee Winstein, Principal Investigator
Organization: University of Southern California
Phone: 3234422903
Responsible Party: Carolee Winstein, University of Southern California
ClinicalTrials.gov Identifier: NCT00871715     History of Changes
Other Study ID Numbers: U01NS056256 ( U.S. NIH Grant/Contract )
U01NS056256 ( U.S. NIH Grant/Contract )
First Submitted: March 27, 2009
First Posted: March 30, 2009
Results First Submitted: February 17, 2016
Results First Posted: April 27, 2016
Last Update Posted: May 11, 2017