Background: Family carepartner management and support can improve stroke survivor recovery, yet research has placed little emphasis on how to integrate families into the rehabilitation process without increasing negative carepartner outcomes. Our group has developed creative approaches for engaging family carepartners in rehabilitation activities to improve physical and psychosocial health for both the carepartner and stroke survivor. The purpose of this study is to explore a novel, web-based intervention (Carepartner and Constraint-Induced Therapy; CARE-CITE) designed to facilitate positive carepartner involvement during a home-based application of constraint-induced movement therapy (CIMT) for the upper extremity.
Methods: The primary aim of the study is to determine feasibility of CARE-CITE for both stroke survivors and their carepartners. Carepartner mental health, family conflict surrounding stroke recovery, and stroke survivor upper extremity function will be evaluated using an evaluator blinded, two-group experimental design (blocked randomization protocol according to a 2:1 randomization schema) with 32 intervention dyads and 16 control dyads (who will receive CIMT without structured carepartner involvement). CARE-CITE consists of online education modules for the carepartner to review in parallel to the 30-h CIMT that the stroke survivor receives. The intent of CARE-CITE is to enhance the home-based intervention of CIMT, by helping the carepartner support the therapy and create a therapeutic home environment encouraging practice of the weaker arm in functional tasks.
Discussion: The CARE-CITE study is testing the feasibility of a family-integrated rehabilitation approach applied in the home environment, and results will provide the foundation for larger clinical studies. The overall significance of this research plan is to increase the understanding and further development of interventions that may serve as models to promote family involvement in the rehabilitation process.
by
Steven L Wolf;
Paul A. Thompson;
Carolee J. Winstein;
J. Phillip Miller;
Sarah Blanton;
Deborah S. Nichols-Larsen;
David M. Morris;
Gitendra Uswatte;
Edward Taub;
Kathye E. Light;
Lumy Sawaki
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 post-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 3–9 months (early group)to participants randomized upon recruitment to receive the identical intervention 15–21 months post-stroke(delayed group).
Methods
Two weeks of CIMT was delivered to participants immediately after randomization (early group) or one year later (delayed group). Evaluators blinded to group designation administered primary (Wolf Motor Function Test [WMFT], Motor Activity Log [MAL]) and secondary (Stroke Impact Scale [SIS]) outcome measures among the 106 early participants and 86 delayed participants prior to delivery of CIMT, two weeks thereafter and 4, 8 and 12 months later.
Results
While both groups showed significant improvements from pretreatment to 12 months post-treatment, the earlier CIMT group showed greater improvement than the delayed CIMT group in WMFT Performance Time and the MAL (P’s < .0001) as well as in Stroke Impact Scale Hand and Activities domains (P <. 0009 and .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 following 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
BACKGROUND
Constraint-induced (CI) movement therapy (also called forced use by some investigators and clinicians) has gained increasing popularity as a treatment mode for restoring function in the upper extremities of patients with stroke. The purpose of this article is to review the concept of constraint-induced movement therapy and provide a critical analysis of the existing data.
REVIEW SUMMARY
The evidence to date offers encouragement for the application of this procedure for patients who have some movement recovery out of synergy. Success may be contingent on patient cooperation and intense repetitive use with applications of retraining through practice and shaping. The extent to which each of the latter elements influences the magnitude of recovery is still unclear. However, task novelty and challenge seem important to recovery of function. There are several methods used to map cortical changes after stroke. At this time, transcranial magnetic stimulation is the primary vehicle used to assess motor cortical reorganization after CI therapy in humans.
CONCLUSIONS
Accumulating data indicate that the size of a cortical area representative of a muscle does expand and its center of gravity does change with CI therapy.
by
Steven L Wolf;
Carolee J. Winstein;
J Phillip Miller;
Paul A. Thompson;
Edward Taub;
Gitendra Uswatte;
David Morris;
Sarah Blanton;
Deborah Nichols-Larsen;
Patricia C. Clark
Background
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.
Method
Measurements were made every four months for impaired upper extremity function (Wolf Motor Function Test - WMFT and Motor Activity Log - MAL) and health related quality of life (Stroke Impact Scale - SIS) amongst 106/222 participants randomized into one arm of the EXCITE Trial in which they received CIMT rather than usual and customary care.
Findings
There was no observed regression from the treatment effects observed at 12 months after treatment during the next 12 months for the primary outcome measures of WMFT and MAL. In fact, the additional changes were in the direction of increased therapeutic effect. For the strength components of the WMFT the changes were significant (P < .05) Secondary outcome variables, including the SIS, exhibited a similar pattern.
Interpretation
Mild to moderately impaired patients who are 3-9 months post-stroke demonstrate substantial improvement in functional use of the paretic upper extremity and quality of life 2 years after receiving a 2-week CIMT intervention. Thus this intervention has persistent benefits.
OBJECTIVE: To develop a remote protocol for the upper extremity Fugl-Meyer Assessment (reFMA) and assess the reliability and validity with in-person delivery. DESIGN: Feasibility testing. SETTING: Remote/virtual and in-person in participants' homes. PARTICIPANTS: Three triads of therapists, stroke survivors, and carepartners (N=9) participated in Phases 1 and 2. Twelve different stroke survivors participated in Phase 3. INTERVENTION: The FMA was administered and received remotely using the instructional protocol (Phases 1 and 2). Pilot testing with the delivery of the reFMA remotely and the FMA in-person occurred in Phase 3. MAIN OUTCOME MEASURES: Feedback for refinement and feasibility of obtaining the reFMA (including the System Usability Scale) and the FMA scores remotely and in-person to assess reliability and validity of the reFMA. RESULTS: The reFMA was refined to incorporate feedback and suggestions from users. Interrater reliability between 2 therapists evaluating the FMA remotely was found to be poor with little agreement. For criterion validity, only 1 out of 12 (8.3%) total scores were in agreement between the in-person and remote assessments. CONCLUSION: Reliable and valid remote administration of the FMA is an important aspect of telerehabilitation for the upper extremity after stroke, but further research is needed to address current protocol limitations. This study provides preliminary support for the need for alternative strategies to improve appropriate implementation of the FMA remotely. Possible explanations for the poor reliability are explored and suggestions for improvement of the remote delivery of the FMA are provided.
OBJECTIVE: Constraint-induced movement therapy (CIMT) has been shown to improve upper extremity voluntary movement and change cortical movement representation after stroke. Direct comparison of the differential degree of cortical reorganization according to chronicity in stroke subjects receiving CIMT has not been performed and was the purpose of this study. We hypothesized that a higher degree of cortical reorganization would occur in the early (less than 9 months post-stroke) compared to the late group (more than 12 months post-stroke).
METHODS: 17 early and 9 late subjects were enrolled. Each subject was evaluated using transcranial magnetic stimulation (TMS) and the Wolf Motor Function Test (WMFT) and received CIMT for 2 weeks.
RESULTS: The early group showed greater improvement in WMFT compared with the late group. TMS motor maps showed persistent enlargement in both groups but the late group trended toward more enlargement. The map shifted posteriorly in the late stroke group. The main limitation was the small number of TMS measures that could be acquired due to high motor thresholds, particularly in the late group.
CONCLUSION: CIMT appears to lead to greater improvement in motor function in the early phase after stroke. Greater cortical reorganization in map size and position occurred in the late group in comparison.
SIGNIFICANCE: The contrast between larger functional gains in the early group vs larger map changes in the late group may indicate that mechanisms of recovery change over the several months following stroke or that map changes are a time-dependent epiphenomenon.
by
Michelle Woodbury;
Craig A. Velozo;
Paul A. Thompson;
Kathye Light;
Gitendra Uswatte;
Edward Taub;
Carolee J. Winstein;
David Morris;
Sarah Blanton;
Deborah S. Nichols-Larsen;
Steven Wolf
Background. Tools chosen to measure poststroke upper-extremity rehabilitation outcomes must match contemporary theoretical expectations of motor deficit and recovery because an assessmentg's theoretical underpinning forms the conceptual basis for interpreting its score. Objective. The purpose of this study was to investigate the theoretical framework of the Wolf Motor Function Test (WMFT) by (1) determining whether all items measured a single underlying trait and (2) examining the congruency between the hypothesized and the empirically determined item difficulty orders. Methods. Confirmatory factor analysis (CFA) and Rasch analysis were applied to existing WMFT Functional Ability Rating Scale data from 189 participants in the EXCITE (Extremity Constraint-Induced Therapy Evaluation) trial. Fit of a 1-factor CFA model (all items) was compared with the fit of a 2-factor CFA model (factors defined according to item object-grasp requirements) with fit indices, model comparison test, and interfactor correlations. Results. One item was missing sufficient data and therefore removed from analysis. CFA fit indices and the model-comparison test suggested that both models fit equally well. The 2-factor model yielded a strong interfactor correlation, and 13 of 14 items fit the Rasch model. The Rasch item difficulty order was consistent with the hypothesized item difficulty order. Conclusion. The results suggest that WMFT items measure a single construct. Furthermore, the results depict an item difficulty hierarchy that may advance the theoretical discussion of the person ability versus task difficulty interaction during stroke recovery.
by
Carolee J. Winstein;
Steven L Wolf;
Alexnader W. Dromerick;
Christianne J. Lane;
Monica A. Nelson;
Rebecca Lawthwaite;
Sarah Blanton;
Charro Scott;
Aimee Reiss;
Steven Yong Cen;
Rahsaan Holley;
Stanley P. Azen
Background
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.
Methods/design
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.
Discussion
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
http://www.ClinicalTrials.gov webcite Identifier: NCT00871715