A web-based carepartner-integrated rehabilitation program for persons with stroke: study protocol for a pilot randomized controlled trial.

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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02703532. Registered 9 March 2016.

The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation.

BACKGROUND: Geographical location, socioeconomic status, and logistics surrounding transportation impede access of poststroke individuals to comprehensive rehabilitative services. Robotic therapy may enhance telerehabilitation by delivering consistent and state-of-the art therapy while allowing remote monitoring and adjusting therapy for underserved populations. The Hand Mentor Pro (HMP) was incorporated within a home exercise program (HEP) to improve upper-extremity (UE) functional capabilities poststroke. OBJECTIVE: To determine the efficacy of a home-based telemonitored robotic-assisted therapy as part of a HEP compared with a dose-matched HEP-only intervention among individuals less than 6 months poststroke and characterized as underserved. METHODS: In this prospective, single-blinded, multisite, randomized controlled trial, 99 hemiparetic participants with limited access to UE rehabilitation were randomized to either (1) the experimental group, which received combined HEP and HMP for 3 h/d ×5 days ×8 weeks, or (2) the control group, which received HEP only at an identical dosage. Weekly communication between the supervising therapist and participant promoted compliance and progression of the HEP and HMP prescription. The Action Research Arm Test and Wolf Motor Function Test along with the Fugl-Meyer Assessment (UE) were primary and secondary outcome measures, respectively, undertaken before and after the interventions. RESULTS: Both groups demonstrated improvement across all UE outcomes. CONCLUSIONS: Robotic + HEP and HEP only were both effectively delivered remotely. There was no difference between groups in change in motor function over time. Additional research is necessary to determine the appropriate dosage of HMP and HEP.

Potential benefits for caregivers of stroke survivors receiving BTX-A and exercise for upper extremity spasticity.

PURPOSE: To explore possible extended benefits to caregivers of stroke survivors receiving a treatment of onabotulinumtoxinA (BTX-A) or saline with a structured exercise program. DESIGN: A comparative, prospective, companion study using a nonrandom sample of 16 caregivers of stroke survivors enrolled in a pilot clinical trial comparing BTX-A or saline and exercise for upper extremity spasticity. METHODS: The caregiver measures were depressive symptoms, care demands, family conflict surrounding stroke recovery, and mental and physical health status. FINDINGS: There were no statistically significant differences between caregiver groups. Caregivers of stroke survivors who received BTX-A had a greater change in depressive symptoms that may reflect a clinically important change. Estimates of effect sizes between the groups, controlling for baseline values, indicate a trend for moderate to large effects (last evaluation) for fewer depressive symptoms (d = 0.52) and less caregiver burden (d = 0.77 time, 0.85 difficulty) for caregivers of the BTX-A group. CONCLUSIONS AND CLINICAL RELEVANCE: Receiving BTX-A did not alter caregiving demands or depressive symptoms compared to those receiving saline. Further research with larger sample sizes is needed to better understand the interdependence of stroke survivors and caregivers on the health of each.

Incorporating robotic-assisted telerehabilitation in a home program to improve arm function following stroke.

BACKGROUND AND PURPOSE: After stroke, many individuals lack resources to receive the intensive rehabilitation that is thought to improve upper extremity motor function. This case study describes the application of a telerehabilitation intervention using a portable robotic device combined with a home exercise program (HEP) designed to improve upper extremity function. CASE DESCRIPTION: The participant was a 54-year-old man, 22 weeks following right medullary pyramidal ischemic infarct. At baseline, he exhibited residual paresis of the left upper extremity, resulting in impaired motor control consistent with a flexion synergistic pattern, scoring 22 of 66 on the Fugl-Meyer Assessment. INTERVENTION: The participant completed 85 total hours of training (38 hours of robotic device and 47 hours of HEP) over the 8-week intervention period. OUTCOMES: The participant demonstrated an improvement of 26 points on the Action Research Arm Test, 5 points on the Functional Ability Scale portion of the Wolf Motor Function Test, and 20 points on the Fugl-Meyer Assessment, all of which surpassed the minimal clinically important difference. Of the 17 tasks of the Wolf Motor Function Test, he demonstrated improvement on 11 of the 15 time-based tasks and both strength measures. The participant reported an overall improvement in his recovery from stroke on the Stroke Impact Scale quality-of-life questionnaire from 40 of 100 to 65 of 100. His score on the Center for Epidemiologic Studies Depression Scale improved by 19 points. DISCUSSION: This case demonstrates that robotic-assisted therapy paired with an HEP can be successfully delivered within a home environment to a person with stroke. Robotic-assisted therapy may be a feasible and efficacious adjunct to an HEP program to elicit substantial improvements in upper extremity motor function, especially in those persons with stroke who lack access to stroke rehabilitation centers.

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

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: www.ClinicalTrials.gov Identifier: NCT00871715

The home stroke rehabilitation and monitoring system trial: a randomized controlled trial.

RATIONALE: Because many individuals poststroke lack access to the quality and intensity of rehabilitation to improve upper extremity motor function, a home-based robotic-assisted upper extremity rehabilitation device is being paired with an individualized home exercise program. AIMS/HYPOTHESIS: The primary aim of this project is to determine the effectiveness of robotic-assisted home therapy compared with a home exercise program on upper extremity motor recovery and health-related quality of life for stroke survivors in rural and underserved locations. The secondary aim is to explore whether initial degree of motor function of the upper limb may be a factor in predicting the extent to which patients with stroke may be responsive to a home therapy approach. We hypothesize that the home exercise program intervention, when enhanced with robotic-assisted therapy, will result in significantly better outcomes in motor function and quality of life. DESIGN: A total of 96 participants within six-months of a single, unilateral ischemic, or hemorrhagic stroke will be recruited in this prospective, single-blind, multisite randomized clinical trial. STUDY OUTCOMES: The primary outcome is the change in upper extremity function using the Action Research Arm Test. Secondary outcomes include changes in: upper extremity function (Wolf Motor Function Test), upper extremity impairment (upper extremity portion of the Fugl-Meyer Test), self-reported quality of life (Stroke Impact Scale), and affect (Centers for Epidemiologic Studies Depression Scale). DISCUSSION: Similar or greater improvements in upper extremity function using the combined robotic home exercise program intervention compared with home exercise program alone will be interpreted as evidence that supports the introduction of in-home technology to augment the recovery of function poststroke.

Constraint-Induced Movement Therapy (CIMT): Current Perspectives and Future Directions.

Constraint-induced movement therapy (CIMT) has gained considerable popularity as a treatment technique for upper extremity rehabilitation among patients with mild-to-moderate stroke. While substantial evidence has emerged to support its applicability, issues remain unanswered regarding the best and most practical approach. Following the establishment of what can be called the "signature" CIMT approach characterized by intense clinic/laboratory-based practice, several distributed forms of training, collectively known as modified constraint therapy (mCIMT), have emerged. There is a need to examine the strengths and limitations of such approaches, and based upon such information, develop the components of a study that would compare the signature approach to the best elements of mCIMT, referred to here as "alternative" CIMT. Based upon a PEDro review of literature, limitations in mCIMT studies for meeting criteria were identified and discussed. A suggestion for a "first effort" at a comparative study that would both address such limitations while taking practical considerations into account is provided.

Further assessment to determine the additive effect of botulinum toxin type A on an upper extremity exercise program to enhance function among individuals with chronic stroke but extensor capability.

OBJECTIVE: To determine whether dose-specified botulinum toxin type A (BTX-A) and a standardized exercise protocol produce better upper extremity function than placebo and the same exercise program. DESIGN: Double-blind randomized trial. SETTING: A rehabilitation research center. PARTICIPANTS: A convenience sample of patients (N=25, age range, 23-76 y) who sustained a stroke 3 to 24 months previously but could initiate wrist extension. INTERVENTIONS: Participants were randomly selected to receive either BTX-A (maximum 300 U) or saline, followed by 12 to 16 exercise sessions. MAIN OUTCOME MEASURES: The primary outcome was the Wolf Motor Function Test (WMFT). Secondary outcome measures included the Modified Ashworth Scale (MAS), active range of motion, and the Stroke Impact Scale (SIS; quality of life). RESULTS: There were no group-by-time interactions for changes in the WMFT and no treatment difference (P=.86), although the BTX-A group could complete more tasks governing proximal joint motions. MAS scores improved for the BTX-A group and worsened for the control group after injection (P=.02), as did the SIS emotion domain (P=.035). CONCLUSIONS: Among chronic stroke survivors, BTX-A did not impact function, movement, or tone more than a standardized exercise program.