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Arm Rehabilitation Study After Stroke (ICARE)

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ClinicalTrials.gov Identifier: NCT00871715
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : April 27, 2016
Last Update Posted : July 9, 2019
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

Brief Summary:
This study is about arm and hand recovery after a stroke. The investigators are testing an experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice compared to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual and customary arm therapy for a duration indicated on the therapy prescription). A second objective is to characterize current outpatient arm therapy (dosage & content) following stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke affecting an arm within the last 106 days.

Condition or disease Intervention/treatment Phase
Stroke Brain Infarction Brain Ischemia Cerebral Infarction Cerebrovascular Disorders Behavioral: Accelerated Skill Acquisition Program (ASAP) Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC Behavioral: Usual and Customary Care - UCC Not Applicable

Detailed Description:
Of the 700,000 individuals who experience a new or recurrent stroke each year, a majority have considerable residual disability. Sixty-five percent (65%) of patients at 6 months are unable to incorporate the paretic hand effectively into daily activities. In turn, this degree of functional deficit contributes to a reduced quality of life after stroke. The extent of disability has been underplayed by the use of the Barthel Index that captures only basic activities of daily living such as self-care and does not extend to activities and participation at higher levels of functioning that are most affected by a residual upper extremity disability. The past decade has witnessed an explosion of different therapy interventions designed to capitalize on the brain's inherent capability to rewire and learn well into old age and more importantly for rehabilitation, after injury. The most effective arm-focused interventions with the strongest evidence and potentially the most immediate and cost-effective appeal for the current health-care environment share a common emphasis on focused task-specific training applied with an intensity higher than usual care. Therefore, our primary aim is to compare the efficacy of a fully defined, hybrid combination of the most effective interventions (forced-use/constraint-induced therapy and skill-based/impairment-mitigating motor learning training), the Accelerated Skill Acquisition Program (ASAP), to an equivalent dose of usual and customary outpatient therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blinded to treatment allocation
Primary Purpose: Treatment
Official Title: Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative
Study Start Date : June 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: ASAP
A focused, intense, evidence-based, upper extremity rehabilitation program, administered during the early post-acute outpatient interval. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence.
Behavioral: Accelerated Skill Acquisition Program (ASAP)
A 30-hour dose is administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session precedes the first visit.
Other Name: ASAP

Active Comparator: DEUCC
Dose-equivalent usual and customary arm therapy administered early post-acutely in the outpatient setting. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.
Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC
Usual and customary arm therapy administered early post-acutely in the outpatient setting, adjusted for dose, but otherwise administered in accordance with usual and customary practices. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.
Other Name: DEUCC

UCC
Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group with treatment dose administered in accordance with usual and customary practices.
Behavioral: Usual and Customary Care - UCC
Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group and treatment dose will be administered in accordance with usual and customary practices.
Other Name: UCC




Primary Outcome Measures :
  1. Wolf Motor Function Test (WMFT) Log-transformed Time [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity.

  2. Wolf Motor Function Test Time [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity.

  3. Stroke Impact Scale (SIS) Hand Function Subscale Score. [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of hand function.

  4. 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 ]
    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.


Secondary Outcome Measures :
  1. Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) [ Time Frame: Baseline to 1 year post-randomization ]
    Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale.

  2. Stroke Impact Scale (SIS) Mobility Subscale Score. [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of mobility.

  3. Stroke Impact Scale (SIS) ADL/IADL Subscale Score. [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of ease with activities queried.

  4. National Institute of Health Stroke Scale (NIHSS) [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (12 months post-randomization) in National Institute of Health Stroke Scale (NIHSS). Range 0-2. Lower scores indicate less stroke severity.

  5. Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box [ Time Frame: Baseline to 1 year post-randomization ]
    Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds.

  6. Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength [ Time Frame: Baseline to 1 year post-randomization ]
    Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization.

  7. Arm Muscle Torque Test - Elbow Extensors [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions.Positive values indicate a strength gain.

  8. Arm Muscle Torque Test - Elbow Flexors [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.

  9. Arm Muscle Torque Test - Shoulder Extensors [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.

  10. Arm Muscle Torque Test - Shoulder Flexors [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.

  11. Arm Muscle Torque Test - Wrist Extensors [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.

  12. Arm Muscle Torque Test - Wrist Flexors [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.

  13. As-Tex Sensory Index [ Time Frame: Baseline to 1 year post-randomization ]
  14. Upper Extremity Fugl Meyer (UEFM), Motor Component [ Time Frame: Baseline to 1 year post-randomization ]
  15. D-KEFS Verbal Fluency Test [ Time Frame: Baseline to 1 year post-randomization ]
  16. Digits Span Backward [ Time Frame: Baseline to 1 year post-randomization ]
  17. Hopkins Verbal Learning Test, Revised (HVLT-R) [ Time Frame: Baseline to 1 year post-randomization ]
  18. Color Trails Making Tests 1 & 2 [ Time Frame: Baseline to 1 year post-randomization ]
  19. Short Blessed Memory Test [ Time Frame: Baseline to 1 year post-randomization ]
  20. Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Baseline to 1 year post-randomization ]
  21. Confidence in Arm & Hand Movement (CAHM) [ Time Frame: Baseline to 1 year post-randomization ]
  22. Stroke Impact Scale (SIS) Communication Subscale Score. [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of ability to communicate and comprehend.

  23. Stroke Impact Scale (SIS) Emotion Subscale Score. [ Time Frame: Baseline to 1 year post-randomization ]
    Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of mood and emotional control.

  24. Motor Activity Log 28 QOM (MAL-28) [ Time Frame: Baseline to 1 year post-randomization ]
  25. EQ5D [ Time Frame: Baseline to 1 year post-randomization ]
  26. Satisfaction With Life Scale (SWLS) [ Time Frame: Baseline to 1 year post-randomization ]
  27. Single-Item Subjective Quality of Life Measurement (SQOL) [ Time Frame: Baseline to 1 year post-randomization ]
  28. Reintegration to Normal Living Index (RNLI) [ Time Frame: Baseline to 1 year post-randomization ]

Other Outcome Measures:
  1. Monthly Telephone Interviews [ Time Frame: monthly, beginning 30 days post-randomization ]
    A monthly telephone interview with the participant to ascertain information about health status, healthcare utilization, medications, other therapies, and adverse events. Some of these data are reported in the adverse event section. Other data (e.g. those related to healthcare utilization) are part of the secondary analyses presently underway. Until published, these are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.

  2. Post-Intervention Interview [ Time Frame: 16-20 weeks post-randomization ]
    A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions to assess the extent to which critical components of the investigational intervention (e.g. impairment mitigation, session intensity, participant chosen tasks, therapist-participant collaboration) were incorporated into each assigned therapy group. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.

  3. Exit Interview [ Time Frame: Post-intervention to 1 year post-randomization ]
    A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions regarding activity since the end of the intervention phase. Participants were also asked to report the perceived value of the intervention and study participation. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION

Ischemic or hemorrhagic stroke.

Hemiparesis in an upper extremity.

Age 21+.

Able to communicate in English (or Spanish,Rancho Los Amigos site only).

Willing to attend outpatient therapy & f/u evaluations for 1 yr.

Some active finger extension.

EXCLUSION

Traumatic or non-vascular brain injury, subarachnoid hemorrhage, AV malformation.

History of psychiatric illness requiring hospitalization within past 24 mos.

Active drug treatment for dementia.

Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS).

History of head trauma requiring >48 hours of hospitalization within past 12 mos.

Amputation of all fingers or thumb of hemiparetic (weak) arm.

Treated with Botox in affected arm within last 3 months.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871715


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Rancho Los Amigos National Rehabilitation Center
Los Angeles, California, United States, 90242
Long Beach Memorial Medical Center
Los Angeles, California, United States, 90806
Huntington Rehabilitation Medicine Associates
Los Angeles, California, United States, 91105
Casa Colina Centers for Rehabilitation
Los Angeles, California, United States, 91769
United States, District of Columbia
National Rehabilitation Hospital
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
University of Southern California
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Carolee J. Winstein, PhD, PT University of Southern California
Principal Investigator: Alexander Dromerick, MD MedStar National Rehabilitation Network
Principal Investigator: Steven Wolf, PhD, PT Emory University
Study Director: Monica A Nelsen, DPT, PT University of Southern California

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carolee Winstein, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00871715     History of Changes
Other Study ID Numbers: U01NS056256 ( U.S. NIH Grant/Contract )
U01NS056256 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2009    Key Record Dates
Results First Posted: April 27, 2016
Last Update Posted: July 9, 2019
Last Verified: June 2019
Keywords provided by Carolee Winstein, University of Southern California:
stroke
hemiparesis
physical therapy
occupational therapy
neurorehabilitation
patient focused
motor learning
motor control
skill acquisition
skill training
motor recovery
task oriented training
task specific training
arm function
hand function
upper extremity
arm therapy
physical rehabilitation
arm rehabilitation
motor function
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Ischemia
Brain Infarction
Infarction
Ischemia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis