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Arm Rehabilitation Study After Stroke (ICARE)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Carolee Winstein, University of Southern California
ClinicalTrials.gov Identifier:
NCT00871715
First received: March 27, 2009
Last updated: March 23, 2016
Last verified: March 2016
Results First Received: February 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stroke
Brain Infarction
Brain Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Interventions: Behavioral: Accelerated Skill Acquisition Program (ASAP)
Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC
Behavioral: Usual and Customary Care - UCC

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between 5 and 106 days post-stroke, predominantly during inpatient rehabilitation, from 7 sites in the United States metropolitan areas of Los Angeles, CA, Atlanta, GA and Washington, D.C.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.


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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   ASAP Accelerated Skill Acquisition Program   DEUCC Dose-Equivalent Usual & Customary Care   UCC Usual & Customary Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 119   120   122   361 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.9  (13.7)   59.9  (10.5)   61.1  (13.1)   60.7  (12.5) 
Gender 
[Units: Participants]
       
Female   55   53   50   158 
Male   64   67   72   203 
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
       
Hispanic or Latino   9   14   13   36 
Not Hispanic or Latino   107   106   107   320 
Unknown or Not Reported   3   0   2   5 
[1] Self-selected from categories determined in 1997 by the U.S. Office of Management and Budget in accordance with sponsor mandate.
Race (NIH/OMB) [1] 
[Units: Participants]
       
American Indian or Alaska Native   4   1   0   5 
Asian   9   7   3   19 
Native Hawaiian or Other Pacific Islander   3   1   3   7 
Black or African American   47   50   54   151 
White   38   43   43   124 
More than one race   3   3   1   7 
Unknown or Not Reported   15   15   18   48 
[1] Self-selected from categories determined in 1997 by the U.S. Office of Management and Budget in accordance with sponsor mandate. For this self-selected measure, 35 participants (9 ASAP, 12 DEUCC, 14 UCC) specified other categories to identify their race. Since an "Other" field is not available, these 35 are included in the count under "Unknown or Not reported"
Region of Enrollment 
[Units: Participants]
       
United States   119   120   122   361 
Education [1] 
[Units: Participants]
       
Less than high school   4   2   2   8 
Some high school   6   12   8   26 
Completed high school   24   21   27   72 
Some college   42   42   46   130 
Completed bachelor's degree   22   26   23   71 
Completed master's degree   15   11   7   33 
Completed doctoral degree   6   6   8   20 
Unknown or Not Reported   0   0   1   1 
[1] Highest level of education completed (self-reported)
Referral source [1] 
[Units: Participants]
       
Inpatient rehabilitation   80   79   88   247 
Outpatient   6   5   5   16 
Acute care   21   26   19   66 
Transitional day program   3   2   2   7 
Open referral   9   7   8   24 
Other   0   1   0   1 
[1] Setting in which participant was first prospectively identified.
Language 
[Units: Participants]
       
English   117   119   121   357 
Spanish   2   1   1   4 
Time from stroke to randomization 
[Units: Days]
Mean (Standard Deviation)
 45.2  (20.3)   45.0  (22.8)   47.0  (23.9)   45.8  (22.4) 
Stroke type 
[Units: Participants]
       
Ischemic without hemorrhagic conversion   100   98   101   299 
Ischemic with hemorrhagic conversion   3   4   4   11 
Intraparenchymal hemorrhagic   16   12   15   43 
Other   0   5   1   6 
Unknown or Not Reported   0   1   1   2 
Stroke location 
[Units: Participants]
       
Right hemisphere   57   56   60   173 
Left hemisphere   49   55   50   154 
Cerebellum   0   1   0   1 
Brain stem   11   5   9   25 
Other   2   3   3   8 
Side of hemiparesis 
[Units: Participants]
       
Right   51   60   57   168 
Left   68   60   65   193 
Stroke severity [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
       
Upper Extremity Motor Fugl-Meyer score   41.7  (9.5)   41.5  (9.2)   41.6  (9.5)   41.6  (9.4) 
National Institutes of Health Stroke Scale score   3.6  (2.0)   3.4  (1.7)   3.7  (1.7)   3.6  (1.8) 
[1]

Upper Extremity Motor Fugl Meyer total score range 0-66; eligible range: 19-58. A lower score indicates greater impairment. For stratification purposes: low severity is greater than or equal to 36; high severity is less than 36.

National Institutes of Health Stroke Scale total score range 0-42; higher values represent greater severity.

Strata [1] 
[Units: Participants]
       
Low severity, early onset   68   70   67   205 
Low severity, late onset   16   16   18   50 
High severity, early onset   23   22   25   70 
High severity, late onset   12   12   12   36 
[1]

Severity: Upper extremity motor Fugl-Meyer score eligible range: 19-58 (low severity is greater than 35; high severity is less than 36).

Stroke onset, time to randomization: eligible range: 14-106 days (early onset is less than 60 days; late onset is greater than 59 days).

Concordance [1] 
[Units: Participants]
       
Concordant   55   64   57   176 
Discordant   64   56   65   185 
[1] Concordant: the paretic limb is the dominant limb. Discordant: the paretic limb is the non-dominant limb.
Pre-randomization outpatient occupational therapy 
[Units: Participants]
 34   29   42   105 
Amount of pre-randomization outpatient occupational therapy 
[Units: Hours]
Mean (Standard Deviation)
 4.4  (3.1)   3.3  (2.3)   3.7  (3.4)   3.8  (3.0) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Wolf Motor Function Test (WMFT) Log-transformed Time   [ Time Frame: Baseline to 1 year post-randomization ]

2.  Primary:   Wolf Motor Function Test Time   [ Time Frame: Baseline to 1 year post-randomization ]

3.  Primary:   Stroke Impact Scale (SIS) Hand Function Subscale Score.   [ Time Frame: Baseline to 1 year post-randomization ]

4.  Primary:   Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization)   [ Time Frame: Baseline to 1 year post-randomization ]

5.  Secondary:   National Institute of Health Stroke Scale (NIHSS)   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

6.  Secondary:   Arm Muscle Torque Test   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

7.  Secondary:   Wolf Motor Function Test (WMFT) Strength Components   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

8.  Secondary:   Upper Extremity Fugl Meyer (UEFM), Motor Component   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

9.  Secondary:   Patient Health Questionnaire 9 (PHQ-9)   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

10.  Secondary:   As-Tex Sensory Index   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

11.  Secondary:   Motor Activity Log 28 QOM (MAL-28)   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

12.  Secondary:   Satisfaction With Life Scale (SWLS)   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

13.  Secondary:   Reintegration to Normal Living Index (RNLI)   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

14.  Secondary:   Single-Item Subjective Quality of Life Measurement (SQOL)   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

15.  Secondary:   EQ5D   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

16.  Secondary:   Confidence in Arm & Hand Movement (CAHM)   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

17.  Secondary:   Short Blessed Memory Test   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

18.  Secondary:   D-KEFS Verbal Fluency Test   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

19.  Secondary:   Hopkins Verbal Learning Test, Revised (HVLT-R)   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

20.  Secondary:   Digits Span Backward   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

21.  Secondary:   Color Trails Making Tests 1 & 2   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

22.  Secondary:   Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)   [ Time Frame: Baseline to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

23.  Other Pre-specified:   Monthly Telephone Interviews   [ Time Frame: monthly, beginning 30 days post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

24.  Other Pre-specified:   Post-Intervention Interview   [ Time Frame: 16-20 weeks post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No

25.  Other Pre-specified:   Exit Interview   [ Time Frame: Post-intervention to 1 year post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Carolee Winstein, Principal Investigator
Organization: University of Southern California
phone: 3234422903
e-mail: winstein@usc.edu


Publications of Results:
Other Publications:

Responsible Party: Carolee Winstein, University of Southern California
ClinicalTrials.gov Identifier: NCT00871715     History of Changes
Other Study ID Numbers: U01NS056256 ( US NIH Grant/Contract Award Number )
Study First Received: March 27, 2009
Results First Received: February 17, 2016
Last Updated: March 23, 2016
Health Authority: United States: Federal Government