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
  Purpose
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 Intervention 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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Wolf Motor Function Test (WMFT) Log-transformed Time [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Wolf Motor Function Test Time [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Stroke Impact Scale (SIS) Hand Function Subscale Score. [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement

  • 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 ] [ Designated as safety issue: No ]
    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:
  • National Institute of Health Stroke Scale (NIHSS) [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Arm Muscle Torque Test [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Wolf Motor Function Test (WMFT) Strength Components [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Upper Extremity Fugl Meyer (UEFM), Motor Component [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • As-Tex Sensory Index [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Motor Activity Log 28 QOM (MAL-28) [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Satisfaction With Life Scale (SWLS) [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Reintegration to Normal Living Index (RNLI) [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Single-Item Subjective Quality of Life Measurement (SQOL) [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • EQ5D [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Confidence in Arm & Hand Movement (CAHM) [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Short Blessed Memory Test [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • D-KEFS Verbal Fluency Test [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Hopkins Verbal Learning Test, Revised (HVLT-R) [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Digits Span Backward [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Color Trails Making Tests 1 & 2 [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.

  • Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) [ Time Frame: Baseline to 1 year post-randomization ] [ Designated as safety issue: No ]
    Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.


Other Outcome Measures:
  • Monthly Telephone Interviews [ Time Frame: monthly, beginning 30 days post-randomization ] [ Designated as safety issue: No ]
    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.

  • Post-Intervention Interview [ Time Frame: 16-20 weeks post-randomization ] [ Designated as safety issue: No ]
    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.

  • Exit Interview [ Time Frame: Post-intervention to 1 year post-randomization ] [ Designated as safety issue: No ]
    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.


Enrollment: 361
Study Start Date: June 2009
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871715

Locations
United States, California
Rancho Los Amigos National Rehabilitation Center
Los Angeles (Downey), California, United States, 90242
Long Beach Memorial Medical Center
Los Angeles (Long Beach), California, United States, 90806
Huntington Rehabilitation Medicine Associates
Los Angeles (Pasadena), California, United States, 91105
Casa Colina Centers for Rehabilitation
Los Angeles (Pomona), California, United States, 91769
University of Southern California
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
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
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
  More Information

Additional Information:
Publications:
Responsible Party: Carolee Winstein, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00871715     History of Changes
Other Study ID Numbers: U01NS056256 
Study First Received: March 27, 2009
Results First Received: February 17, 2016
Last Updated: March 23, 2016
Health Authority: United States: Federal Government

Keywords provided by 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:
Stroke
Infarction
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Ischemia
Brain Infarction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 23, 2016