Extremity Constraint Induced Therapy Evaluation Research Articles

Rehabilitation of motor function after stroke: A bibliometric analysis of global research from 2004 to 2022.

The mortality rate of stroke has been increasing worldwide. Poststroke somatic dysfunctions are common. Motor function rehabilitation of patients with such somatic dysfunctions enhances the quality of life and has long been the primary practice to achieve functional recovery. In this regard, we aimed to delineate the new trends and frontiers in stroke motor function rehabilitation literature published from 2004 to 2022 using a bibliometric software. All documents related to stroke rehabilitation and published from 2004 to 2022 were retrieved from the Web of Science Core Collection. Publication output, research categories, countries/institutions, authors/cocited authors, journals/cocited journals, cocited references, and keywords were assessed using VOSviewer v.1.6.15.0 and CiteSpace version 5.8. The cocitation map was plotted according to the analysis results to intuitively observe the research hotspots. Overall, 3,302 articles were retrieved from 78 countries or regions and 564 institutions. Over time, the publication outputs increased annually. In terms of national contribution, the United States published the most papers, followed by China, Japan, South Korea, and Canada. Yeungnam University had the most articles among all institutions, followed by Emory University, Fudan University, and National Taiwan University. Jang Sung Ho and Wolf S.L. were the most productive (56 published articles) and influential (cited 1,121 times) authors, respectively. "Effect of constraint-induced movement therapy on upper extremity function 3-9 months after stroke: the Extremity Constraint Induced Therapy Evaluation randomized clinical trial" was the most frequently cited reference. Analysis of keywords showed that upper limbs, Fugl-Meyer assessment, electromyography, virtual reality, telerehabilitation, exoskeleton, and brain-computer interface were the research development trends and focus areas for this topic. Publications regarding motor function rehabilitation following stroke are likely to continuously increase. Research on virtual reality, telemedicine, electroacupuncture, the brain-computer interface, and rehabilitation robots has attracted increasing attention, with these topics becoming the hotspots of present research and the trends of future research.

Minimal Detectable Change of the Actual Amount of Use Test and the Motor Activity Log

Background. Efficacy of task-oriented training can be reliably trusted only when the inherent measurement variability is determined. The Actual Amount of Use Test (AAUT) and the Motor Activity Log (MAL) have been used together as measures of spontaneous arm use after an intervention; however, the minimal detectable change (MDC) of AAUT and MAL has not been addressed. Objective. To compare the MDC90 of the AAUT and the MAL in the context of a randomized controlled trial of a neurorehabilitation intervention, the Extremity Constraint-Induced Therapy Evaluation trial. Methods. A preplanned secondary analysis was conducted using pre–post test data from the control group. Estimated MDC90 were normalized to the maximum value of the scale of the AAUT and the MAL for each subscale: amount of use (AAUTa, MALa) and quality of movement (AAUTq, MALq). Results. The MDC90 of the AAUTq and the MALq were 14.4% and 15.4%, respectively. However, the MDC90 required greater change for the AAUTa (24.2%) than the MALa (16.8%). The training-induced spontaneous arm use exceeded the MDC90 for the MAL but fell below that for the AAUT immediately after the intervention and at 1-year follow-up visit. Conclusions. The greater variability and insensitivity to treatment effect for the AAUTa is likely because of the low resolution of its scoring system. As such, there is a considerable need to develop valid and reliable tools that capture purposeful arm use outside the laboratory, perhaps through leveraging new sensing technologies with objective activity monitoring.

Improving Outcomes After Stroke By LEAPS (Locomotor Experience Applied Post-Stroke) and Bounds

Stroke is a chronic, lasting condition. Over 795 000 persons have a new stroke each year.1 The vast majority survive, with those in the seventh decade living an average of 7 years thereafter,1 most with some form of loss of function and limitation of activity.2 Increasing evidence suggests that these deficits are not fixed, but instead that the brain is plastic, that a number of different therapies have the potential to improve brain structure and function once the acute stroke period passes and stroke injury is fixed, and that this plasticity can reduce poststroke disability. Brain plasticity is facilitated by repeated practice. This is true during development, during learning, in times of health, and after brain injury such as stroke. This principle is the foundation of poststroke treatments applied across behavioral modalities such as neglect, aphasia, or weakness. Evidence suggests that the responsiveness of the brain to such intervention declines with time poststroke.3 However, many patients long past stroke can nonetheless benefit from repeated practice such as with an activity-based regimen that is initiated even months after stroke onset. For example, the Extremity Constraint Induced Therapy Evaluation (EXCITE) trial was a landmark study that found that constraint-induced therapy improved upper extremity motor function when initiated 3 to 9 months after stroke onset.4 It is in this context that the Locomotor Experience Applied Post-Stroke (LEAPS) trial was initiated. The LEAPS trial focused on improving gait after stroke by comparing 2 different activity-based therapies and 2 different time points. Gait is a priority because it is commonly affected by stroke, gait improvements after stroke are linked to better quality of life,5 and hemiplegic patients rank recovery of gait as their top priority.6 Importantly, gait velocity is linked to level of social participation.7 A typical …

A functional threshold for long-term use of hand and arm function can be determined: Predictions from a computational model and supporting data from the extremity constraint-induced therapy evaluation (EXCITE) trial

Background. Although spontaneous use of the more-affected arm and hand after stroke is an important determinant of participation and quality of life, a number of patients exhibit decreases in use following rehabilitative therapy. A previous neurocomputational model predicted that if the dose of therapy is sufficient to bring performance above a certain threshold, training can be stopped. Objective. The aim of this study was to test the hypothesis that there exists a threshold for function of the paretic arm and hand after therapy. If function is above this threshold, spontaneous use will increase in the months following therapy. In contrast, if function is below this threshold, spontaneous use will decrease. Methods. New computer simulations are presented showing that changes in arm use following therapy depend on a performance threshold. This prediction was tested by reanalyzing the data from the Extremity Constraint-Induced Therapy Evaluation (EXCITE) trial, phase III randomized controlled trial in which participants received constraint-induced movement therapy for 2 weeks and were tested both 1 week and 1 year after therapy. Results. The results demonstrate that arm and hand function measured immediately after therapy predicts, on average, the long-term change of arm use. Above a functional threshold, use improves. Below this threshold, use decreases. Limitations. The reanalysis of the EXCITE trial data provides a “group” threshold above which a majority of patients, but not all, improve spontaneously. A goal of future research is to provide the means to assess when patients reach their individual threshold. Conclusion. Understanding of the causal and nonlinear relationship between limb function and daily use is important for the future development of cost-effective interventions and prevention of “rehabilitation in vain.”

A Functional Threshold for Long-Term Use of Hand and Arm Function Can Be Determined: Predictions From a Computational Model and Supporting Data From the Extremity Constraint-Induced Therapy Evaluation (EXCITE) Trial

Although spontaneous use of the more-affected arm and hand after stroke is an important determinant of participation and quality of life, a number of patients exhibit decreases in use following rehabilitative therapy. A previous neurocomputational model predicted that if the dose of therapy is sufficient to bring performance above a certain threshold, training can be stopped. The aim of this study was to test the hypothesis that there exists a threshold for function of the paretic arm and hand after therapy. If function is above this threshold, spontaneous use will increase in the months following therapy. In contrast, if function is below this threshold, spontaneous use will decrease. New computer simulations are presented showing that changes in arm use following therapy depend on a performance threshold. This prediction was tested by reanalyzing the data from the Extremity Constraint-Induced Therapy Evaluation (EXCITE) trial, a phase III randomized controlled trial in which participants received constraint-induced movement therapy for 2 weeks and were tested both 1 week and 1 year after therapy. The results demonstrate that arm and hand function measured immediately after therapy predicts, on average, the long-term change of arm use. Above a functional threshold, use improves. Below this threshold, use decreases. The reanalysis of the EXCITE trial data provides a "group" threshold above which a majority of patients, but not all, improve spontaneously. A goal of future research is to provide the means to assess when patients reach their individual threshold. Understanding of the causal and nonlinear relationship between limb function and daily use is important for the future development of cost-effective interventions and prevention of "rehabilitation in vain."

A Method for Standardizing Procedures in Rehabilitation: Use in the Extremity Constraint Induced Therapy Evaluation Multisite Randomized Controlled Trial

Morris DM, Taub E, Macrina DM, Cook EW, Geiger BF. A method for standardizing procedures in rehabilitation: use in the Extremity Constraint Induced Therapy Evaluation multisite randomized controlled trial. Objective An enduring problem in the field of rehabilitation has been the lack of standardization in the protocols of treatments and tests. To develop a process evaluation method to standardize the administration of rehabilitation procedures used in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial, a randomized controlled trial of upper-extremity constraint-induced therapy implemented across 7 sites. Design Process evaluation. Setting Research laboratory. Participants Convenience sample or research personnel. Interventions Not applicable. Main Outcome Measures Checklist scoring sheets were developed to rate videotapes using systematic application of prescribed steps for each of 5 procedures across 3 time periods. Time periods were immediately after training, and 1 and 2 years later. A performance score of at least 90% was required before individual research personnel were allowed to participate in the trial. Results Overall performance scores ranged from 85.8% to 95% of performance items correctly executed. There was a significant improvement in standard performance of procedures between the first time period (immediately after training) and each of the subsequent time periods for all but 1 procedure. The scoring of standardized performance when carried out with routine participant testing and training did not differ significantly from scoring from videotaped sessions submitted for standardization rating for 2 of the procedures, suggesting adequate validity of scoring from videotape. Conclusions The present method was successful in assessing protocol fidelity for the EXCITE research personnel and represents 1 means of addressing the longstanding problem in rehabilitation of the lack of standardization in administering different treatments and tests.

Can the Wolf Motor Function Test be Streamlined?

Background. To assess upper extremity (UE) capabilities following stroke, the Wolf Motor Function Test (WMFT) measures time to complete 15 UE tasks and 2 strength tasks, but takes 30 to 45 minutes for the clinician to complete. Objective. In an effort to streamline the WMFT, this study evaluated the association between the magnitude of improvement on any timed task of the WMFT and the change score on all other tasks among participants in the Extremity Constraint Induced Therapy Evaluation (EXCITE) trial. Methods. This association was evaluated using regression methods according to chronicity and controlling for key covariates (functional level, gender, concordance) for log mean WMFT scores. Results. After controlling for covariates, 6 tasks (hand to table [front], hand to box [front], reach and retrieve, lift can, lift pencil, and fold towel) influenced the overall WMFT score for survivors meeting EXCITE criteria and treated within 3 to 9 months poststroke. Six different tasks (extend elbow weight, hand to box [front], lift can, lift pencil, turn key in lock, and fold towel) influenced the overall WMFT score for those receiving constraint-induced movement therapy (CIMT) 1 year later. The importance of certain tasks relative to others may best represent overall UE function, but this streamlining enables the clinician to prioritize these tasks in the evaluation. Conclusions. The delineation of those tasks depends on the time poststroke from enrollment to CIMT. This study demonstrates that the WMFT can be streamlined from 17 to 6 tasks.

Pros and Woes of Interdisciplinary Collaboration With a National Clinical Trial

Nursing collaborations with clinical trials provide opportunities to answer important nursing questions, enhance interdisciplinary collaboration, use collected data efficiently, include sophisticated measures, and answer questions that could not be answered by either project alone. To foster interdisciplinary collaboration, the National Institute of Nursing Research (NINR) issued a funding initiative to link nurse researchers and clinical trial teams. This article describes a successful collaboration between Extremity Constraint-Induced Therapy Evaluation (EXCITE), a multisite, national clinical trial, and Caregiver-EXCITE, a complementary nursing study funded by NINR. EXCITE tested a neurorehabilitative technique to improve upper extremity function in stroke survivors, whereas Caregiver-EXCITE addressed hypotheses about family function, stroke recovery, and caregiver outcomes. This article addresses advantages and challenges of this collaboration and provides illustrations of excellent opportunities that joint ventures offer to advance science. These types of collaborations have the potential to profoundly move nursing's research agenda forward.

The EXCITE Trial: Predicting a Clinically Meaningful Motor Activity Log Outcome

Background and Objective . This study determined which baseline clinical measurements best predicted a predefined clinically meaningful outcome on the Motor Activity Log (MAL) and developed a predictive multivariate model to determine outcome after 2 weeks of constraint-induced movement therapy (CIMT) and 12 months later using the database from participants in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial. Methods. A clinically meaningful CIMT outcome was defined as achieving higher than 3 on the MAL Quality of Movement (QOM) scale. Predictive variables included baseline MAL, Wolf Motor Function Test (WMFT), the sensory and motor portion of the Fugl-Meyer Assessment (FMA), spasticity, visual perception, age, gender, type of stroke, concordance, and time after stroke. Significant predictors identified by univariate analysis were used to develop the multivariate model. Predictive equations were generated and odds ratios for predictors were calculated from the multivariate model. Results. Pretreatment motor function measured by MAL QOM, WMFT, and FMA were significantly associated with outcome immediately after CIMT. Pretreatment MAL QOM, WMFT, proprioception, and age were significantly associated with outcome after 12 months. Each unit of higher pretreatment MAL QOM score and each unit of faster pretreatment WMFT log mean time improved the probability of achieving a clinically meaningful outcome by 7 and 3 times at posttreatment, and 5 and 2 times after 12 months, respectively. Patients with impaired proprioception had a 20% probability of achieving a clinically meaningful outcome compared with those with intact proprioception. Conclusions. Baseline clinical measures of motor and sensory function can be used to predict a clinically meaningful outcome after CIMT.

On “Modified constraint-induced therapy…” Page et al. Phys Ther. 2008;88:333–340

Over the past 6 years, Stephen J Page, PhD, FAHA, has shown a remarkable level of research productivity with considerable efforts directed toward a modification of constraint-induced movement therapy (mCIMT)—or constraint-induced therapy (mCIT)—and its interfaces with other modalities or approaches, including functional electrical stimulation, electromyographic-triggered electrical stimulation, telerehabilitation, and mental practice. These efforts have resulted in the genesis of a perspective that mCIT is a reimbursable procedure1,2 or “a reimbursable protocol.”3(p339) Before this form of mCIT progresses toward the next logical step—a phase III randomized controlled study—a pause for reflection may be in order. This response is intended to offer a critical assessment and allows us to contemplate if, indeed, the cart is being placed too far before the horse. The “signature” form of CIT requires intensive practice, the primary factor that differentiates it from the distributed practice forms of CIT that generally have been referred to as “modified.” Undoubtedly, there are frustrations that might occur with such concentrated effort required over 10 or 15 weekdays of training for up to 6 hours per day. In the recently completed EXtremity Constraint-Induced Therapy Evaluation (EXCITE) Trial,4,5 the average duration of daily training (actual time on task) over 10 days using repetitive task practice and adaptive task practice (shaping) was 3 hours. Many of the 222 EXCITE participants simply did not possess the endurance to train for the entire 6 hours; in fact, the average time progressed from 1.5 hours to 4.5 hours. Given a mean of 3 hours over 10 days, the total on-task time was 30 hours for the signature CIT that characterized EXCITE. In contrast, the present study3 used approximately half that time (1.5 hours of clinic-based training per week over 10 weeks, for a total of 15 contact hours). However, …

Six hours in the laboratory: a quantification of practice time during constraint-induced therapy (CIT)

Objective: To quantify supervised in-laboratory time and practice intensity during the signature protocol specified as 6 hours/day over 10 days for the EXtremity Constraint-Induced Therapy Evaluation (EXCITE) randomized clinical trial. Design: Retrospective analysis of constraint-induced movement therapy training documentation acquired at the University of Southern California site from EXCITE (n = 38). Training documentation was reviewed and analysed to determine average and between-subject variability of supervised in-laboratory time and actual task-specific practice time for concurrence with the specified constraint-induced movement therapy protocol. Setting: Motor Behavior and Neurorehabilitation Laboratory, Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA. Subjects: Data from 38 participants (35 met inclusion criteria) who, upon enrolment in the EXCITE trial, were between 3 and 10 months post stroke and between 47 and 81 years of age. Results: The training records revealed an average of 64 hours (SD = 2.6) supervised in-laboratory time for 35 participants across 10 days of training. More importantly, the average time on task-specific practice was 3.95 hours per day (SD = 5.7) representing 62% of the in-laboratory time. Supervised in-laboratory time for 10 training days was consistent across the sample as was total practice time for days 2—10, with a substantially lower practice time on the initial training day. Conclusions: Participants tolerated an intense task-specific practice schedule that consisted of approximately two-thirds of the specified minimum 6 hour in-laboratory time and was distributed evenly between adaptive task practice (shaping) and task practice components.

The EXCITE Trial

Marc Fisher MD Kennedy Lees MD Section Editors: Much of the attention in the field of stroke is focused on prevention, emergency response, and management of the acute inpatient stay. Despite these efforts, many patients are left with substantial disability. Patients survive their stroke for a mean of 8 years, making poststroke disability a highly prevalent condition; most of the days during which stroke affects the life of the patient occur in this chronic disability phase. Increased attention is being paid to an emerging set of therapeutic targets that are related to repair and restoration. Such restorative therapies focus on improving function in surviving brain areas rather than salvaging acutely threatened tissue and therefore might be available to a high proportion of patients with stroke. Animal studies have suggested a wide range of potential restorative therapies, including interventions based on physical, cellular, pharmacological, and electromagnetic approaches. However, to date, there has been limited translation of these preclinical findings into late-phase human clinical trials. In this regard, the Extremity Constraint Induced Therapy Evaluation (EXCITE) trial1 is a major step forward. It is unique among trials of restorative interventions for its size, meticulous multisite organization, preparation,2 duration of follow up, derivation from biological principle, and application of clinical trial methodology. In many ways, the EXCITE trial represents a paradigmatic shift in restorative stroke trials. The EXCITE trial was a prospective, single-blind, randomized, multisite clinical study conducted at 7 US academic institutions between 2001 and 2003. The study randomized a total of 222 patients with a first ischemic or …

Looking in the Rear View Mirror When Conversing With Back Seat Drivers: The EXCITE Trial Revisited

The initial Point of View: Directions for Research (Neurorehabilitation and Neural Repair, 2007;21:3-13) identified confounders that might limit the impact that rehabilitation multicenter clinical trials may have upon altering practice patterns. Part of that viewpoint addressed the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial and highlighted some of its perceived strengths and limitations. The present Point of View expands upon factors worthy of consideration in planning and executing clinical trials in neurorehabilitation based upon experiences encountered by the EXCITE team. Cost factors and patient attributes, both of which profoundly influence the ability of clinical researchers to execute the ideal study, are among these factors. In particular, the costs associated with large trials necessitate compromise in study design or implementation, resulting in a dichotomy between what should be undertaken and what can be accomplished.

Interpreting the Randomized Clinical Trial of Constraint-Induced Movement Therapy

JAMA Effect of Constraint-Induced Movement Therapy on Upper Extremity Function 3 to 9 Months After Stroke: The EXCITE Randomized Clinical Trial Steven L. Wolf, PhD, PT; Carolee J. Winstein, PhD, PT; J. Philip Miller, AB; Edward Taub, PhD; Gitendra Uswatte, PhD; David Morris, PhD, PT; Carol Giuliani, PhD, PT; Kathye E. Light, PhD, PT; Deborah Nichols-Larsen, PhD, PT; for the EXCITE Investigators Context: Single-site studies suggest that a 2-week program of constraint-induced movement therapy (CIMT) for patients more than 1 year after stroke who maintain some hand and wrist movement can improve upper extremity function that persists for at least 1 year. Objective: To compare the effects of a 2-week multisite program of CIMT vs usual and customary care on improvement in upper extremity function among patients who had a first stroke within the previous 3 to 9 months. Design and Setting: The Extremity Constraint Induced Therapy Evaluation (EXCITE) trial, a prospective, single-blind, randomized, multisite clinical trial conducted at 7 US academic institutions between January 2001 and January 2003. Participants: Two hundred twenty-two individuals with predominantly ischemic stroke. Interventions: Participants were assigned to receive either CIMT (n = 106; wearing a restraining mitt on the less-affected hand while engaging in repetitive task practice and behavioral shaping with the hemiplegic hand) or usual and customary care (n = 116; ranging from no treatment after concluding formal rehabilitation to pharmacologic or physiotherapeutic interventions); patients were stratified by sex, prestroke dominant side, side of stroke, and level of paretic arm function. Main Outcome Measures: The Wolf Motor Function Test (WMFT), a measure of laboratory time and strength-based ability and quality of movement (functional ability), and the Motor Activity Log (MAL), a measure of how well and how often 30 common daily activities are performed. Results: From baseline to 12 months, the CIMT group showed greater improvements than the control group in both the WMFT Performance Time (decrease in mean time from 19.3 seconds to 9.3 seconds [52% reduction] vs from 24.0 seconds to 17.7 seconds [26% reduction]; between-group difference, 34% [95% confidence interval {CI}, 12%-51%]; P P Conclusion: Among patients who had a stroke within the previous 3 to 9 months, CIMT produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least 1 year. Trial Registration: clinicaltrials.gov Identifier:NCT00057018

Confounders in Rehabilitation Trials of Task-Oriented Training: Lessons From the Designs of the EXCITE and SCILT Multicenter Trials

Two multicenter randomized clinical trials (MRCT), the Extremity Constraint Induced Therapy Evaluation (EXCITE) to improve upper extremity function after stroke and the Spinal Cord Injury Locomotor Trial (SCILT) to enable functional walking after incomplete spinal cord injury, demonstrate that complex, task-oriented physical therapies can be studied using a scientific methodology during inpatient or outpatient rehabilitation. In the past, a new therapy’s benefit may have been overestimated by comparing it to no treatment or to a conventional treatment at a low intensity of practice. Sample sizes were often too small and may have failed to detect the efficacy of a new intervention. In addition, whereas statistical significance in outcomes has been critical to understanding whether one treatment is better than another, the clinical significance of outcomes must also impact the interpretation of the results of a trial. MRCT designs will continue to improve through attention to the limitations of preclinical animal models that offer a conceptual basis for the treatment, from enrichment strategies at every phase of trial development, from more vigorous dose-response studies using adaptive methods, by capturing interim measures of behavior and functional neurophysiologic adaptations during the treatment phase, by aiming for a clinically meaningful control intervention, and by including ratio or interval outcome measures when feasible that capture a target of the intervention in relation to gains in daily functioning and quality of life.

Effect of Constraint-Induced Movement Therapy on Upper Extremity Function 3 to 9 Months After Stroke

Single-site studies suggest that a 2-week program of constraint-induced movement therapy (CIMT) for patients more than 1 year after stroke who maintain some hand and wrist movement can improve upper extremity function that persists for at least 1 year. To compare the effects of a 2-week multisite program of CIMT vs usual and customary care on improvement in upper extremity function among patients who had a first stroke within the previous 3 to 9 months. The Extremity Constraint Induced Therapy Evaluation (EXCITE) trial, a prospective, single-blind, randomized, multisite clinical trial conducted at 7 US academic institutions between January 2001 and January 2003. Two hundred twenty-two individuals with predominantly ischemic stroke. Participants were assigned to receive either CIMT (n = 106; wearing a restraining mitt on the less-affected hand while engaging in repetitive task practice and behavioral shaping with the hemiplegic hand) or usual and customary care (n = 116; ranging from no treatment after concluding formal rehabilitation to pharmacologic or physiotherapeutic interventions); patients were stratified by sex, prestroke dominant side, side of stroke, and level of paretic arm function. The Wolf Motor Function Test (WMFT), a measure of laboratory time and strength-based ability and quality of movement (functional ability), and the Motor Activity Log (MAL), a measure of how well and how often 30 common daily activities are performed. From baseline to 12 months, the CIMT group showed greater improvements than the control group in both the WMFT Performance Time (decrease in mean time from 19.3 seconds to 9.3 seconds [52% reduction] vs from 24.0 seconds to 17.7 seconds [26% reduction]; between-group difference, 34% [95% confidence interval {CI}, 12%-51%]; P<.001) and in the MAL Amount of Use (on a 0-5 scale, increase from 1.21 to 2.13 vs from 1.15 to 1.65; between-group difference, 0.43 [95% CI, 0.05-0.80]; P<.001) and MAL Quality of Movement (on a 0-5 scale, increase from 1.26 to 2.23 vs 1.18 to 1.66; between-group difference, 0.48 [95% CI, 0.13-0.84]; P<.001). The CIMT group achieved a decrease of 19.5 in self-perceived hand function difficulty (Stroke Impact Scale hand domain) vs a decrease of 10.1 for the control group (between-group difference, 9.42 [95% CI, 0.27-18.57]; P=.05). Among patients who had a stroke within the previous 3 to 9 months, CIMT produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least 1 year. Trial Registration clinicaltrials.gov Identifier: NCT00057018.

Lessons Learned in Participant Recruitment and Retention: The EXCITE Trial

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.

Validity of Accelerometry for Monitoring Real-World Arm Activity in Patients With Subacute Stroke: Evidence From the Extremity Constraint-Induced Therapy Evaluation Trial

Uswatte G, Giuliani C, Winstein C, Zeringue A, Hobbs L, Wolf SL. Validity of accelerometry for monitoring real-world arm activity in patients with subacute stroke: evidence from the Extremity Constraint-Induced Therapy Evaluation trial. Objective To examine the psychometric properties of an objective method for assessing real-world arm activity in a large sample with subacute stroke. Design Validation study. Setting Community. Participants Persons 3 to 9 months poststroke (N=169) with mild to moderate motor impairment of their hemiparetic arm enrolled in a multisite, randomized clinical trial of constraint-induced movement therapy. Interventions Not applicable. Main Outcome Measures Participants wore an accelerometer on each arm outside the laboratory for 3 days before and after treatment or an equivalent no-treatment period. They also completed the Actual Amount of Use Test (AAUT), which is an observational measure of spontaneous more-impaired arm use, and the Motor Activity Log (MAL), which is an interview assessing more-impaired arm use in daily life. Results Low-pass–filtered accelerometer recordings were reliable ( r range, >.8) and stable ( P range, >.48). Their validity was also supported. Correlations calculated across all participants at baseline between the ratio of more-impaired to less-impaired arm accelerometer recordings and AAUT and MAL scores were .60 and .52, respectively. Conclusions Accelerometry provides an objective, real-world index of more-impaired arm activity with good psychometric properties.

Pain, Fatigue, and Intensity of Practice in People With Stroke Who Are Receiving Constraint-Induced Movement Therapy

There is little available information about changes in pain and fatigue status among people receiving constraint-induced movement therapy (CI therapy). This study examined such changes. All participants were a subset of individuals with stroke enrolled in the Extremity Constraint-Induced Therapy Evaluation (EXCITE) trial and received 2 weeks of CI therapy either 3 to 9 months after stroke (subacute therapy group, n=18) or 1 year later (chronic therapy group, n=14). Pain, fatigue, and intensity of therapy were evaluated. The Wolf Motor Function Test (WMFT) and the pain scale of the Fugl-Meyer Assessment for the upper extremity were administered before and after training. Single-item measures for pain and fatigue were administered twice daily during therapy. All participants reported low mean pain (X=2.0, SD=0.93) and fatigue (X=2.7, SD=1.23) scores. Generally, differences between the subacute and the chronic therapy groups for pain, fatigue, intensity, and WMFT change scores were nonsignificant. For selected patients with stroke, the intensive practice associated with CI therapy may be administered without exacerbation of pain or fatigue, even early during the recovery process.

The 2006 International Stroke Conference Orlando, Florida February 15-18, 2006

The 2006 International Stroke Conference Orlando, Florida February 15-18, 2006