Arm Rehabilitation Study After Stroke (ICARE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Wolf Motor Function Test (WMFT) time measures: determines the time required to perform 15 standardized tasks with each upper extremity. [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Stroke Impact Scale (SIS)- assesses changes in impairments, disabilities and handicaps following a stroke. [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Arm Muscle Torque Test [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Wolf Motor Function Test (WMFT) strength components [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Upper Extremity Fugl Meyer (UEFM), Motor Component [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- As-Tex Sensory Index [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Motor Activity Log 28 QOM (MAL-28) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Satisfaction with Life Scale (SWLS) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Reintegration to Normal Living Index (RNLI) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Single-Item Subjective Quality of Life Measurement (SQOL) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- EQ5D [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Confidence in Arm & Hand Movement (CAHM) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Short Blessed Memory Test [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- D-KEFS Verbal Fluency Test [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Hopkins Verbal Learning Test, Revised (HVLT-R) [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Digits Span Backward [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Color Trails Making Tests 1 & 2 [ Time Frame: 1 year post-randomization ] [ Designated as safety issue: No ]
- Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) [ Time Frame: 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.
| Enrollment: | 361 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | February 2014 |
| Estimated 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 (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 | |
| 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 | |
| Principal Investigator: | Carolee J. Winstein, PhD, PT | University of Southern California |
| Principal Investigator: | Alexander Dromerick, MD | National Rehabilitation Hospital |
| 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: | University of Southern California |
| ClinicalTrials.gov Identifier: | NCT00871715 History of Changes |
| Other Study ID Numbers: | U01-NS056256, U01NS056256 |
| Study First Received: | March 27, 2009 |
| Last Updated: | March 29, 2013 |
| 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:
|
Cerebral Infarction Stroke Brain Ischemia Cerebrovascular Disorders Infarction 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 May 23, 2013