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

Abstract

BackgroundResidual 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.Methods/designFollowing 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.DiscussionICARE 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 registrationhttp://www.ClinicalTrials.gov Identifier: NCT00871715

Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke

“…The protocol and design for this phase 3, parallel, 3-group, single-blind, randomized clinical trial are provided in Supplement 1 and were detailed in the ICARE methods article. 5 Following institutional review board approvals at each site, participants provided written informed consent. A data and safety monitoring board and medical monitor provided independent oversight.…”

“…The ASAP Manual of Procedures was embargoed during the trial 5 ; it included a formal standardization process. All ASAP therapists signed nondisclosure agreements.…”

“…5 A 12-monthchange in the log-transformed Wolf Motor Function Test (WMFT) time score was the primary outcome. The WMFT time score is a mean of 15 hierarchically arranged timed arm movements and hand dexterity tasks.…”

“…Adverse events were reported regarding 3 independent characteristics: expectedness, relation to study, and severity. 5 …”

Does Task-Oriented Practice Improve Upper Extremity Motor Recovery after Stroke? A Systematic Review

“…Most rehabilitation clinicians and researchers agree that the frequency and duration of an intervention can be quantified using minutes per day and number of days over which an intervention is administered. There is less agreement about the definition of intensity, with some considering the more physiologic interpretation (e.g., the energy expenditure, which can be measured by scales such as Metabolic Equivalent of Task (MET)) [27,28] while others define it as the minutes per day on a prescribed protocol, where the goal is the maximum amount of task practice in the time provided [29,30]. Given that intensity describes the concentration of the active ingredient in task-oriented practice, time on task, as opposed to the energy expended on task, is the more appropriate measure.…”