Trial Outcomes & Findings for Arm Rehabilitation Study After Stroke (NCT NCT00871715)
NCT ID: NCT00871715
Last Updated: 2019-07-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
361 participants
Primary outcome timeframe
Baseline to 1 year post-randomization
Results posted on
2019-07-09
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
119
|
120
|
122
|
|
Overall Study
Post-Intervention
|
112
|
115
|
115
|
|
Overall Study
6-mo Follow-up
|
110
|
113
|
112
|
|
Overall Study
COMPLETED
|
104
|
104
|
96
|
|
Overall Study
NOT COMPLETED
|
15
|
16
|
26
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
10
|
15
|
|
Overall Study
Physician Decision
|
6
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
9
|
Baseline Characteristics
Arm Rehabilitation Study After Stroke
Baseline characteristics by cohort
| Measure |
ASAP Accelerated Skill Acquisition Program
n=119 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=120 Participants
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.
|
UCC Usual & Customary Care
n=122 Participants
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
n=361 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
320 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=5 Participants
|
120 participants
n=7 Participants
|
122 participants
n=5 Participants
|
361 participants
n=4 Participants
|
|
Education
Less than high school
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Education
Some high school
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
8 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Education
Completed high school
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
27 participants
n=5 Participants
|
72 participants
n=4 Participants
|
|
Education
Some college
|
42 participants
n=5 Participants
|
42 participants
n=7 Participants
|
46 participants
n=5 Participants
|
130 participants
n=4 Participants
|
|
Education
Completed bachelor's degree
|
22 participants
n=5 Participants
|
26 participants
n=7 Participants
|
23 participants
n=5 Participants
|
71 participants
n=4 Participants
|
|
Education
Completed master's degree
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
7 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Education
Completed doctoral degree
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Education
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Referral source
Inpatient rehabilitation
|
80 participants
n=5 Participants
|
79 participants
n=7 Participants
|
88 participants
n=5 Participants
|
247 participants
n=4 Participants
|
|
Referral source
Outpatient
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Referral source
Acute care
|
21 participants
n=5 Participants
|
26 participants
n=7 Participants
|
19 participants
n=5 Participants
|
66 participants
n=4 Participants
|
|
Referral source
Transitional day program
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Referral source
Open referral
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Referral source
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Language
English
|
117 participants
n=5 Participants
|
119 participants
n=7 Participants
|
121 participants
n=5 Participants
|
357 participants
n=4 Participants
|
|
Language
Spanish
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Time from stroke to randomization
|
45.2 days
STANDARD_DEVIATION 20.3 • n=5 Participants
|
45.0 days
STANDARD_DEVIATION 22.8 • n=7 Participants
|
47.0 days
STANDARD_DEVIATION 23.9 • n=5 Participants
|
45.8 days
STANDARD_DEVIATION 22.4 • n=4 Participants
|
|
Stroke type
Ischemic without hemorrhagic conversion
|
100 participants
n=5 Participants
|
98 participants
n=7 Participants
|
101 participants
n=5 Participants
|
299 participants
n=4 Participants
|
|
Stroke type
Ischemic with hemorrhagic conversion
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Stroke type
Intraparenchymal hemorrhagic
|
16 participants
n=5 Participants
|
12 participants
n=7 Participants
|
15 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Stroke type
Other
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Stroke type
Unknown or Not Reported
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Stroke location
Right hemisphere
|
57 participants
n=5 Participants
|
56 participants
n=7 Participants
|
60 participants
n=5 Participants
|
173 participants
n=4 Participants
|
|
Stroke location
Left hemisphere
|
49 participants
n=5 Participants
|
55 participants
n=7 Participants
|
50 participants
n=5 Participants
|
154 participants
n=4 Participants
|
|
Stroke location
Cerebellum
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Stroke location
Brain stem
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Stroke location
Other
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Side of hemiparesis
Right
|
51 participants
n=5 Participants
|
60 participants
n=7 Participants
|
57 participants
n=5 Participants
|
168 participants
n=4 Participants
|
|
Side of hemiparesis
Left
|
68 participants
n=5 Participants
|
60 participants
n=7 Participants
|
65 participants
n=5 Participants
|
193 participants
n=4 Participants
|
|
Stroke severity
Upper Extremity Motor Fugl-Meyer score
|
41.7 units on a scale
STANDARD_DEVIATION 9.5 • n=5 Participants
|
41.5 units on a scale
STANDARD_DEVIATION 9.2 • n=7 Participants
|
41.6 units on a scale
STANDARD_DEVIATION 9.5 • n=5 Participants
|
41.6 units on a scale
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Stroke severity
National Institutes of Health Stroke Scale score
|
3.6 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Strata
Low severity, early onset
|
68 participants
n=5 Participants
|
70 participants
n=7 Participants
|
67 participants
n=5 Participants
|
205 participants
n=4 Participants
|
|
Strata
Low severity, late onset
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
18 participants
n=5 Participants
|
50 participants
n=4 Participants
|
|
Strata
High severity, early onset
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
25 participants
n=5 Participants
|
70 participants
n=4 Participants
|
|
Strata
High severity, late onset
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Concordance
Concordant
|
55 participants
n=5 Participants
|
64 participants
n=7 Participants
|
57 participants
n=5 Participants
|
176 participants
n=4 Participants
|
|
Concordance
Discordant
|
64 participants
n=5 Participants
|
56 participants
n=7 Participants
|
65 participants
n=5 Participants
|
185 participants
n=4 Participants
|
|
Pre-randomization outpatient occupational therapy
|
34 participants
n=5 Participants
|
29 participants
n=7 Participants
|
42 participants
n=5 Participants
|
105 participants
n=4 Participants
|
|
Amount of pre-randomization outpatient occupational therapy
|
4.4 hours
STANDARD_DEVIATION 3.1 • n=5 Participants
|
3.3 hours
STANDARD_DEVIATION 2.3 • n=7 Participants
|
3.7 hours
STANDARD_DEVIATION 3.4 • n=5 Participants
|
3.8 hours
STANDARD_DEVIATION 3.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=104 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=104 Participants
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.
|
UCC Usual & Customary Care
n=96 Participants
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.
|
|---|---|---|---|
|
Wolf Motor Function Test (WMFT) Log-transformed Time
|
-0.8 log(seconds)
Interval -1.0 to -0.6
|
-0.9 log(seconds)
Interval -1.0 to -0.7
|
-0.8 log(seconds)
Interval -1.0 to -0.6
|
PRIMARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=104 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=104 Participants
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.
|
UCC Usual & Customary Care
n=96 Participants
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.
|
|---|---|---|---|
|
Wolf Motor Function Test Time
|
-8.1 seconds
Interval -11.7 to -4.5
|
-8.7 seconds
Interval -11.6 to -5.8
|
-7.5 seconds
Interval -10.5 to -4.6
|
PRIMARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=105 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=107 Participants
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.
|
UCC Usual & Customary Care
n=101 Participants
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.
|
|---|---|---|---|
|
Stroke Impact Scale (SIS) Hand Function Subscale Score.
|
37.6 units on a scale
Interval 31.7 to 43.5
|
35.7 units on a scale
Interval 30.4 to 40.9
|
37.1 units on a scale
Interval 32.2 to 42.1
|
PRIMARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=99 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=104 Participants
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.
|
UCC Usual & Customary Care
n=99 Participants
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.
|
|---|---|---|---|
|
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
|
72.1 percentage of participants
|
68.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationAssesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=105 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=107 Participants
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.
|
UCC Usual & Customary Care
n=101 Participants
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.
|
|---|---|---|---|
|
Stroke Impact Scale (SIS) Mobility Subscale Score.
|
11.22 units on a scale
Standard Deviation 22.53
|
12.08 units on a scale
Standard Deviation 21.15
|
14.91 units on a scale
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=105 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=107 Participants
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.
|
UCC Usual & Customary Care
n=101 Participants
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.
|
|---|---|---|---|
|
Stroke Impact Scale (SIS) ADL/IADL Subscale Score.
|
22.69 units on a scale
Standard Deviation 20.33
|
21.53 units on a scale
Standard Deviation 18.76
|
23.22 units on a scale
Standard Deviation 18.88
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=104 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=104 Participants
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.
|
UCC Usual & Customary Care
n=91 Participants
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.
|
|---|---|---|---|
|
National Institute of Health Stroke Scale (NIHSS)
|
-1.67 score on a scale
Standard Deviation 2.28
|
-1.61 score on a scale
Standard Deviation 1.79
|
-1.76 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationWolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationWolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=95 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=98 Participants
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.
|
UCC Usual & Customary Care
n=85 Participants
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.
|
|---|---|---|---|
|
Arm Muscle Torque Test - Elbow Extensors
|
20.0 kilograms
Standard Deviation 47.33
|
15.73 kilograms
Standard Deviation 48.10
|
14.58 kilograms
Standard Deviation 50.28
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=95 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=99 Participants
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.
|
UCC Usual & Customary Care
n=85 Participants
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.
|
|---|---|---|---|
|
Arm Muscle Torque Test - Elbow Flexors
|
30.41 kilograms
Standard Deviation 52.03
|
20.78 kilograms
Standard Deviation 56.39
|
24.21 kilograms
Standard Deviation 45.13
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=91 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=94 Participants
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.
|
UCC Usual & Customary Care
n=79 Participants
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.
|
|---|---|---|---|
|
Arm Muscle Torque Test - Shoulder Extensors
|
25.61 kilograms
Standard Deviation 56.63
|
20.76 kilograms
Standard Deviation 55.23
|
18.64 kilograms
Standard Deviation 59.04
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=90 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=93 Participants
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.
|
UCC Usual & Customary Care
n=79 Participants
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.
|
|---|---|---|---|
|
Arm Muscle Torque Test - Shoulder Flexors
|
21.41 kilograms
Standard Deviation 57.12
|
24.4 kilograms
Standard Deviation 51.90
|
19.74 kilograms
Standard Deviation 47.86
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=95 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=97 Participants
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.
|
UCC Usual & Customary Care
n=85 Participants
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.
|
|---|---|---|---|
|
Arm Muscle Torque Test - Wrist Extensors
|
15.19 kilograms
Standard Deviation 37.59
|
18.07 kilograms
Standard Deviation 34.03
|
18.12 kilograms
Standard Deviation 32.07
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=93 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=99 Participants
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.
|
UCC Usual & Customary Care
n=85 Participants
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.
|
|---|---|---|---|
|
Arm Muscle Torque Test - Wrist Flexors
|
16.24 kilograms
Standard Deviation 39.37
|
10.71 kilograms
Standard Deviation 30.21
|
8.96 kilograms
Standard Deviation 28.76
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=105 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=107 Participants
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.
|
UCC Usual & Customary Care
n=101 Participants
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.
|
|---|---|---|---|
|
Stroke Impact Scale (SIS) Communication Subscale Score.
|
6.23 units on a scale
Standard Deviation 17.38
|
2.97 units on a scale
Standard Deviation 14.67
|
3.11 units on a scale
Standard Deviation 13.05
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationPopulation: 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.
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.
Outcome measures
| Measure |
ASAP Accelerated Skill Acquisition Program
n=105 Participants
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=107 Participants
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.
|
UCC Usual & Customary Care
n=101 Participants
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.
|
|---|---|---|---|
|
Stroke Impact Scale (SIS) Emotion Subscale Score.
|
3.49 units on a scale
Standard Deviation 17.81
|
3.63 units on a scale
Standard Deviation 17.21
|
3.36 units on a scale
Standard Deviation 15.52
|
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 year post-randomizationOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: monthly, beginning 30 days post-randomizationA 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-20 weeks post-randomizationA 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-intervention to 1 year post-randomizationA 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.
Outcome measures
Outcome data not reported
Adverse Events
ASAP Accelerated Skill Acquisition Program
Serious events: 37 serious events
Other events: 67 other events
Deaths: 0 deaths
DEUCC Dose-Equivalent Usual & Customary Care
Serious events: 36 serious events
Other events: 69 other events
Deaths: 0 deaths
UCC Usual & Customary Care
Serious events: 32 serious events
Other events: 55 other events
Deaths: 0 deaths
Screened But Not Randomized
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ASAP Accelerated Skill Acquisition Program
n=119 participants at risk
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=120 participants at risk
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.
|
UCC Usual & Customary Care
n=122 participants at risk
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.
|
Screened But Not Randomized
n=772 participants at risk
Individuals who consented to an in-person screening assessment for eligibility but were never randomized.
|
|---|---|---|---|---|
|
General disorders
Death
|
0.84%
1/119 • Number of events 1 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.83%
1/120 • Number of events 1 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
1.6%
2/122 • Number of events 2 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Nervous system disorders
Recurrent Stroke or TIA
|
10.9%
13/119 • Number of events 18 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
7.5%
9/120 • Number of events 13 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
5.7%
7/122 • Number of events 9 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.26%
2/772 • Number of events 2 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Cardiac disorders
MI or Acute Coronary Syndrome
|
0.84%
1/119 • Number of events 1 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
2.5%
3/120 • Number of events 3 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
3.3%
4/122 • Number of events 6 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Cardiac disorders
New onset of Cardiac Arrhythmia
|
1.7%
2/119 • Number of events 2 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.83%
1/120 • Number of events 1 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
1.6%
2/122 • Number of events 2 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
4.2%
5/119 • Number of events 6 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
4.2%
5/120 • Number of events 5 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
4.9%
6/122 • Number of events 6 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/119 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/120 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/122 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
General disorders
Inpatient Hospitalization or ER visit >23 hours
|
23.5%
28/119 • Number of events 45 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
26.7%
32/120 • Number of events 46 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
23.0%
28/122 • Number of events 48 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.52%
4/772 • Number of events 4 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
2/119 • Number of events 2 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/120 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
1.6%
2/122 • Number of events 2 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Vascular disorders
Excessive blood pressure response
|
0.84%
1/119 • Number of events 1 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.83%
1/120 • Number of events 1 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
2.5%
3/122 • Number of events 3 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.13%
1/772 • Number of events 1 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
General disorders
Unexpected/Other
|
1.7%
2/119 • Number of events 2 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.83%
1/120 • Number of events 1 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/122 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.13%
1/772 • Number of events 1 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
Other adverse events
| Measure |
ASAP Accelerated Skill Acquisition Program
n=119 participants at risk
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.
|
DEUCC Dose-Equivalent Usual & Customary Care
n=120 participants at risk
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.
|
UCC Usual & Customary Care
n=122 participants at risk
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.
|
Screened But Not Randomized
n=772 participants at risk
Individuals who consented to an in-person screening assessment for eligibility but were never randomized.
|
|---|---|---|---|---|
|
General disorders
Fall with No Fracture
|
34.5%
41/119 • Number of events 67 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
26.7%
32/120 • Number of events 41 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
18.9%
23/122 • Number of events 28 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
4/119 • Number of events 7 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
5.0%
6/120 • Number of events 6 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
2.5%
3/122 • Number of events 5 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Skin and subcutaneous tissue disorders
Open sore or cuts
|
6.7%
8/119 • Number of events 10 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
10.8%
13/120 • Number of events 15 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
3.3%
4/122 • Number of events 6 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness or pain that persists for more than 48 hours
|
24.4%
29/119 • Number of events 53 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
22.5%
27/120 • Number of events 29 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
23.8%
29/122 • Number of events 38 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain that limits study participation
|
13.4%
16/119 • Number of events 24 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
14.2%
17/120 • Number of events 19 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
16.4%
20/122 • Number of events 27 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Vascular disorders
Excessive blood pressure response
|
12.6%
15/119 • Number of events 30 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
12.5%
15/120 • Number of events 18 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
2.5%
3/122 • Number of events 4 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.13%
1/772 • Number of events 1 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
General disorders
Dizziness/Fainting
|
8.4%
10/119 • Number of events 12 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
10.8%
13/120 • Number of events 14 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
7.4%
9/122 • Number of events 10 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.7%
2/119 • Number of events 2 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/120 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.82%
1/122 • Number of events 1 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
|
General disorders
Unexpected SAEs
|
8.4%
10/119 • Number of events 11 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
10.0%
12/120 • Number of events 12 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
5.7%
7/122 • Number of events 8 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
0.00%
0/772 • From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.
|
Additional Information
Carolee Winstein, Principal Investigator
University of Southern California
Phone: 3234422903
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place