Background and Purpose— Health-related quality of life (HRQOL) is an important index of outcome after stroke and may facilitate a broader description of stroke recovery. This study examined the relationship of individual and clinical characteristics to HRQOL in stroke survivors with mild to moderate stroke during subacute recovery. Methods— Two hundred twenty-nine participants 3 to 9 months poststroke were enrolled in a national multisite clinical trial (Extremity Constraint-Induced Therapy Evaluation). HRQOL was assessed using the Stroke Impact Scale (SIS), Version 3.0. The Wolf Motor Function Test documented functional recovery of the hemiplegic upper extremity. Multiple analysis of variance and regression models examined the influence of demographic and clinical variables across SIS domains. Results— Age, gender, education level, stroke type, concordance (paretic arm=dominant hand), upper extremity motor function (Wolf Motor Function Test), and comorbidities were associated across SIS domains. Poorer HRQOL in the physical domain was associated with age, nonwhite race, more comorbidities, and reduced upper-extremity function. Stroke survivors with more comorbidities reported poorer HRQOL in the area of memory and thinking, and those with an ischemic stroke and concordance reported poorer communication. Conclusions— Although results may not generalize to lower functioning stroke survivors, individual characteristics of persons with mild to moderate stroke may be important to consider in developing comprehensive, targeted interventions designed to maximize recovery and improve HRQOL.

This article describes the study design, methodological considerations, and demographic characteristics of a phase III RCT to determine if 1) constraint-induced therapy (CI therapy) can be applied with therapeutic success 3 to 9 months after stroke across different sites, 2) gains that might occur persist over 2 years, 3) initial level of motor ability determines responsiveness to CI therapy, and 4) the treatment effect differs between those treated before 9 months and after 1 year. Six sites will screen and recruit poststroke survivors stratified on initial level of motor ability and after randomization allocate participants to immediate or delayed intervention. Primary outcomes include a laboratory-based measure of function (Wolf Motor Function Test [WMFT]) and a real-world participant-centered functional use measure (Motor Activity Log [MAI]). Secondary outcomes concern function, behavior, and compliance. This is the first multisite, single-blind RCT of a formal training intervention for upper extremity rehabilitation in subacute stroke in the United States.

SummaryBackground-Constraint-Induced Movement therapy (CIMT) uses a variety of treatment components, including restricted use of the better upper extremity, to promote increased use of the contralesional limb for many hours each weekday over two consecutive weeks. The EXCITE Trial demonstrated the efficacy of this intervention for patients 3-9 months post-stroke who were followed for the next 12 months. We assessed the retention of improvements through 24 months.

Background-Constraint-induced movement therapy (CIMT) has received considerable attention as an intervention to enhance motor recovery and cortical reorganization after stroke.

Participant recruitment is considered the most difficult aspect of the research process. Despite the integral role of recruitment in randomized clinical trials, publication of data defining the recruitment effort is not routine in rehabilitation initiatives. The recruitment process for the Extremity Constraint-Induced Therapy Evaluation (EXCITE) trial illustrates obstacles to and strategies for participant accrual and retention that are inherent in rehabilitation clinical trials. The purpose of this article is to increase awareness of the multiple facets of recruitment necessary for successful clinical trials, thus supporting the continued development of evidence-based practice in physical therapy. The Recruitment Index is presented as a variable to measure recruitment efficacy. In addition, ethical aspects of recruitment are explored, including informed consent and the concept of therapeutic misconception.

Background and Purpose— Although constraint-induced movement therapy (CIMT) has been shown to improve upper extremity function in stroke survivors at both early and late stages after stroke, the comparison between participants within the same cohort but receiving the intervention at different time points has not been undertaken. Therefore, the purpose of this study was to compare functional improvements between stroke participants randomized to receive this intervention within 3 to 9 months (early group) to participants randomized on recruitment to receive the identical intervention 15 to 21 months after stroke (delayed group). Methods— Two weeks of CIMT was delivered to participants immediately after randomization (early group) or 1 year later (delayed group). Evaluators blinded to group designation administered primary (Wolf Motor Function Test, Motor Activity Log) and secondary (Stroke Impact Scale) outcome measures among the 106 early participants and 86 delayed participants before delivery of CIMT, 2 weeks thereafter, and 4, 8, and 12 months later. Results— Although both groups showed significant improvements from pretreatment to 12 months after treatment, the earlier CIMT group showed greater improvement than the delayed CIMT group in Wolf Motor Function Test Performance Time and the Motor Activity Log ( P <0.0001), as well as in Stroke Impact Scale Hand and Activities domains ( P <0.0009 and 0.0214, respectively). Early and delayed group comparison of scores on these measures 24 months after enrollment showed no statistically significant differences between groups. Conclusions— CIMT can be delivered to eligible patients 3 to 9 months or 15 to 21 months after stroke. Both patient groups achieved approximately the same level of significant arm motor function 24 months after enrollment. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00057018.

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

BACKGROUND-Constraint-induced (CI) movement therapy (also called forced use by some