Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): A randomized controlled trial protocol

BMC Neurology (Impact Factor: 2.04). 01/2013; 13(1):5. DOI: 10.1186/1471-2377-13-5
Source: PubMed


Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.
The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC.
Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.
The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05.
ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose.
Trial registration Identifier: NCT00871715

Download full-text


Available from: Steven L Wolf
  • Source
    • "There is a variety of existing arm-hand programs, each tackling one or more of the aforementioned problems. For example, the ICARE protocol (Winstein et al., 2013) and the task-specific training method of Arya et al. (2012) both provide a structured framework and customized therapy with challenging activities related to the real-world tasks chosen by the patient. The amount of training time in the BATRAC bilateral arm training (van Delden, Peper, Beek, & Kwakkel, 2011) shows similarities with the training intensity of the CARAS' "
    [Show abstract] [Hide abstract]
    ABSTRACT: Abstract The volume of information on new treatment techniques supporting the restoration of arm-hand function (AHF) and arm-hand skill performance (ASHP) in stroke survivors overwhelms therapists in everyday clinical practice when choosing the appropriate therapy. The Concise Arm and Hand Rehabilitation Approach in Stroke (CARAS) is designed for paramedical staff to structure and implement training of AHF and AHSP in stroke survivors. The CARAS is based on four constructs: (a) stratification according to the severity of arm–hand impairment (using the Utrecht Arm/Hand -Test [UAT]), (b) the individual’s rehabilitation goals and concomitant potential rehabilitation outcomes, (c) principles of self-efficacy, and (d) possibilities to systematically incorporate (new) technology and new evidence-based training elements swiftly. The framework encompasses three programs aimed at treating either the severely (UAT 0-1), moderately (UAT 2-3), or mildly (UAT 4-7) impaired arm-hand. Program themes are: taking care of the limb and prevention of complications (Program 1), task-oriented gross motor grip performance (Program 2), and functional AHSP training (Program 3). Each program is preceded and followed by an assessment. Training modularity facilitates rapid interchange/adaptation of sub-elements. Proof-of-principle in clinical rehabilitation has been established. The CARAS facilitates rapid structured design and provision of state-of-the-art AHF and ASHP treatment in stroke patients.
    Full-text · Article · Oct 2015
  • [Show abstract] [Hide abstract]
    ABSTRACT: The purpose of this review is to provide an update on the latest neurorehabilitation literature for motor recovery in stroke and traumatic brain injury to assist clinical decision making and assessing future research directions. The emerging approach to motor restoration is now multimodal. It engages the traditional multidisciplinary rehabilitation team, but incorporates highly structured activity-based therapies, pharmacology, brain stimulation and robotics. Clinical trial data support selective serotonin reuptake inhibitors and amantadine to assist motor recovery poststroke and traumatic brain injury, respectively. Similarly, there is continued support for intensity as a key factor in activity-based therapies, across skilled and nonskilled interventions. Aerobic training appears to have multiple benefits; increasing the capacity to meet the demands of hemiparetic gait improves endurance for activities of daily living while promoting cognition and mood. At this time, the primary benefit of robotic therapy lies in the delivery of highly intense and repetitive motor practice. Both transcranial direct current and magnetic stimulation therapies are in early stages, but have promise in motor and language restoration. Advancements in neurorehabilitation have shifted treatment away from nonspecific activity regimens and amphetamines. As the body of knowledge grows, evidence-based practice using interventions targeted at specific subgroups becomes progressively more feasible.
    No preview · Article · Oct 2013 · Current opinion in neurology
  • [Show abstract] [Hide abstract]
    ABSTRACT: Stroke is the fourth leading cause of death in the United States, but remains a leading cause of disability. As more stroke victims survive with advanced acute care, effective strategies and interventions are required to optimize poststroke outcomes. In recent years, knowledge with respect to stroke recovery has expanded greatly through completion of preclinical and clinical trials. Emerging technology may provide further treatment options beyond the standard therapy and practices. In this article, the authors review recent advances in stroke recovery and rehabilitation, including the major determinants of poststroke recovery, challenges in translational stroke recovery research, and several emerging rehabilitation modalities such as noninvasive brain stimulation, brain-computer interface, biotherapeutics, and pharmacologic agents. Potential future directions in research are also addressed.
    No preview · Article · Nov 2013 · Seminars in Neurology
Show more

We use cookies to give you the best possible experience on ResearchGate. Read our cookies policy to learn more.