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

ABSTRACT: 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.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.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.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).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.

SUBMITTER: Linder SM

PROVIDER: S-EPMC4362540 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature

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

Linder Susan M SM Rosenfeldt Anson B AB Reiss Aimee A Buchanan Sharon S Sahu Komal K Bay Curtis R CR Wolf Steven L SL Alberts Jay L JL

International journal of stroke : official journal of the International Stroke Society 20130101 1

<h4>Rationale</h4>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.<h4>Aims/hypothesis</h4>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 q ...[more]

PMID: 23280269

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Project description:BackgroundThis study investigates the effectiveness of a self-developed intelligent monitoring system for home-based knee rehabilitation following total knee arthroplasty (TKA).MethodsIn this randomized controlled trial, 120 patients undergoing TKA were divided using random digit allocation. Preoperative and one-month postoperative assessments of knee function, quality of life, and isometric knee extension strength were conducted with the Intelligent Monitoring System. Patients received group-specific rehabilitation instructions pre-discharge and performed exercises for one month.ResultsChanges in isometric knee extensor strength on the affected side within one month post-surgery for the brace-monitored rehabilitation group showed a significant decrease three days after surgery compared to one day before surgery. Subsequent measurements taken at postoperative days 5, 7, 14, and 21 indicated a gradual increase in strength, although these increases did not reach statistical significance when compared with previous measurements. One month post-surgery, all groups demonstrated significant improvements in knee joint function and mobility compared to pre-surgery levels. Notably, the brace-monitored group showed statistically significant improvements in 36-Item Short-Form Health Survey (SF-36) scores over the conventional rehabilitation group.ConclusionsThe Intelligent Monitoring System provides effective real-time monitoring and guidance for home-based knee rehabilitation post-TKA. It significantly enhances knee joint function, isometric knee extension strength, and quality of life shortly after surgery compared to traditional rehabilitation methods. This system offers a promising approach for improving postoperative recovery in TKA patients.Trial registrationThis study was approved by the Medical Ethics Committee of Xiangya Hospital, Central South University (Ethics Approval Number 202209008-2). It was registered with the China Clinical Trial Registry, a primary registry of the World Health Organization's International Clinical Trials Registry Platform (Registration Number ChiCTR2300068852).

Project description:BackgroundIn contrast to the large and increasing number of patients with stroke, clinical rehabilitation resources cannot meet their rehabilitation needs. Especially for those discharged, ways to carry out effective rehabilitation training without the supervision of physicians and receive guidance from physicians remain urgent problems to be solved in clinical rehabilitation and have become a research hot spot at home and abroad. At present, there are many studies on home rehabilitation training based on wearable devices, Kinect, among others, but these have disadvantages (eg, complex systems, high price, and unsatisfactory rehabilitation effects).ObjectiveThis study aims to design a remote intelligent rehabilitation training system based on wearable devices and human-computer interaction training tasks, and to evaluate the effectiveness and safety of the remote rehabilitation training system for nonphysician-supervised motor rehabilitation training of patients with stroke through a clinical trial study.MethodsA total of 120 inpatients with stroke having limb motor dysfunction were enrolled via a randomized, parallel-controlled method in the rehabilitation institutions, and a 3-week clinical trial was conducted in the rehabilitation hall with 60 patients in the experimental group and 60 in the control group. The patients in the experimental group used the remote rehabilitation training system for rehabilitation training and routine clinical physical therapy (PT) training and received routine drug treatment every day. The patients in the control group received routine clinical occupational therapy (OT) training and routine clinical PT training and routine drug treatment every day. At the beginning of the training (baseline) and after 3 weeks, the Fugl-Meyer Motor Function Rating scale was scored by rehabilitation physicians, and the results were compared and analyzed.ResultsStatistics were performed using SAS software (version 9.4). The total mean Fugl-Meyer score improved by 11.98 (SD 8.46; 95% CI 9.69-14.27) in the control group and 17.56 (SD 11.65; 95% CI 14.37-20.74) in the experimental group, and the difference between the 2 groups was statistically significant (P=.005). Among them, the mean Fugl-Meyer upper extremity score improved by 7.45 (SD 7.24; 95% CI 5.50-9.41) in the control group and 11.28 (SD 8.59; 95% CI 8.93-13.62) in the experimental group, and the difference between the 2 groups was statistically significant (P=.01). The mean Fugl-Meyer lower extremity score improved by 4.53 (SD 4.42; 95% CI 3.33-5.72) in the control group and 6.28 (SD 5.28; 95% CI 4.84-7.72) in the experimental group, and there was no significant difference between the 2 groups (P=.06). The test results showed that the experimental group was better than the control group, and that the patients' motor ability was improved.ConclusionsThe remote rehabilitation training system designed based on wearable devices and human-computer interaction training tasks can replace routine clinical OT training. In the future, through medical device registration certification, the system will be used without the participation of physicians or therapists, such as in rehabilitation training halls, and in remote environments, such as communities and homes.Trial registrationChinese Clinical Trial Registry ChiCTR2200061310; https://tinyurl.com/34ka2725.

Project description:ObjectiveTo determine whether home monitoring with the ForeseeHome device (Notal Vision Ltd, Tel Aviv, Israel), using macular visual field testing with hyperacuity techniques and telemonitoring, results in earlier detection of age-related macular degeneration-associated choroidal neovascularization (CNV), reflected in better visual acuity, when compared with standard care. The main predictor of treatment outcome from anti-vascular endothelial growth factor (VEGF) agents is the visual acuity at the time of CNV treatment.DesignUnmasked, controlled, randomized clinical trial.ParticipantsOne thousand nine hundred and seventy participants 53 to 90 years of age at high risk of CNV developing were screened. Of these, 1520 participants with a mean age of 72.5 years were enrolled in the Home Monitoring of the Eye study at 44 Age-Related Eye Disease Study 2 clinical centers.InterventionsIn the standard care and device arms arm, investigator-specific instructions were provided for self-monitoring vision at home followed by report of new symptoms to the clinic. In the device arm, the device was provided with recommendations for daily testing. The device monitoring center received test results and reported changes to the clinical centers, which contacted participants for examination.Main outcome measuresThe main outcome measure was the difference in best-corrected visual acuity scores between baseline and detection of CNV. The event was determined by investigators based on clinical examination, color fundus photography, fluorescein angiography, and optical coherence tomography findings. Masked graders at a central reading center evaluated the images using standardized protocols.ResultsSeven hundred sixty-three participants were randomized to device monitoring and 757 participants were randomized to standard care and were followed up for a mean of 1.4 years between July 2010 and April 2013. At the prespecified interim analysis, 82 participants progressed to CNV, 51 in the device arm and 31 in the standard care arm. The primary analysis achieved statistical significance, with the participants in the device arm demonstrating a smaller decline in visual acuity with fewer letters lost from baseline to CNV detection (median, -4 letters; interquartile range [IQR], -11.0 to -1.0 letters) compared with standard care (median, -9 letters; IQR, -14.0 to -4.0 letters; P = 0.021), resulting in better visual acuity at CNV detection in the device arm. The Data and Safety Monitoring Committee recommended early study termination for efficacy.ConclusionsPersons at high risk for CNV developing benefit from the home monitoring strategy for earlier detection of CNV development, which increases the likelihood of better visual acuity results after intravitreal anti-VEGF therapy.

Project description:ObjectiveFew effective treatments improve upper extremity (UE) function after stroke. Immersive virtual reality (imVR) is a novel and promising strategy for stroke UE recovery. We assessed the extent to which imVR-based UE rehabilitation can augment conventional treatment and explored changes in brain functional connectivity (FC) that were related to the rehabilitation.MethodsAn assessor-blinded, parallel-group randomized controlled trial was performed with 40 subjects randomly assigned to either imVR or Control group (1:1 allocation), each receiving rehabilitation 5 times per week for 3 weeks. Subjects in the imVR received both imVR and conventional rehabilitation, while those in the Control received conventional rehabilitation only. Our primary and secondary outcomes were the Fugl-Meyer assessment's upper extremity subscale (FMA-UE) and the Barthel Index (BI), respectively. Both intention-to-treat (ITT) and per-protocol (PP) analyses were performed to assess the effectiveness of the trial. For both the FMA-UE/BI, a one-way analysis of covariance (ANCOVA) model was used, with the FMA-UE/BI at post-intervention or at follow-up, respectively, as the dependent variable, the two groups as the independent variable, baseline FMA-UE/BI, age, sex, site, time since onset, hypertension and diabetes as covariates.ResultsBoth ITT and PP analyses demonstrated the effectiveness of imVR-based rehabilitation. The FMA-UE score was greater in the imVR compared with the Control at the post-intervention (mean difference: 9.1 (95% CI 1.6, 16.6); P = 0.019) and follow-up (mean difference:11.5 (95% CI 1.9, 21.0); P = 0.020). The results were consistent for BI scores. Moreover, brain FC analysis found that the motor function improvements were associated with a change in degree in ipsilesional premotor cortex and ipsilesional dorsolateral prefrontal cortex immediately following the intervention and in ipsilesional visual region and ipsilesional middle frontal gyrus after the 12-week follow-up.ConclusionsImVR-based rehabilitation is an effective tool that can improve the recovery of UE functional capabilities of subacute stroke patients when added to standard care. These improvements were associated with distinctive brain changes at two post-stroke timepoints. The study results will benefit future patients with stroke and provide evidence for a promising new method of stroke rehabilitation.Trial registrationClinicalTrials.gov identifier: NCT03086889.

Project description:BackgroundStroke patients usually suffer primary cognitive impairment related to attention, memory, and executive functions. This impairment causes a negative impact on the quality of life of patients and their families, and may be long term. Cognitive rehabilitation has been shown to be an effective way to treat cognitive impairment and should be continued after hospital discharge. Computerized cognitive rehabilitation can be performed at home using exercise programs that advance with predetermined course content, interval, and pace. We hypothesize that computerized rehabilitation might be improved if a program could customize course content and pace in response to patient-specific progress. The present pilot study is a randomized controlled double-blind crossover clinical trial aiming to study if chronic stroke patients with cognitive impairment could benefit from cognitive training through a customized tele-rehabilitation platform ("Guttmann, NeuroPersonalTrainer"®, GNPT®).Methods/designIndividuals with chronic-stage stroke will be recruited. Participants will be randomized to receive experimental intervention (customized tele-rehabilitation platform, GNPT®) or sham intervention (ictus.online), both with the same frequency and duration (five sessions per week over 6 weeks). After a washout period of 3 months, crossover will occur and participants from the GNPT® condition will receive sham intervention, while participants originally from the sham intervention will receive GNPT®. Patients will be assessed before and after receiving each treatment regimen with an exhaustive neuropsychological battery. Primary outcomes will include rating measures that assess attention difficulties, memory failures, and executive dysfunction for daily activities, as well as performance-based measures of attention, memory, and executive functions.DiscussionCustomized cognitive training could lead to better cognitive function in patients with chronic-stage stroke and improve their quality of life.Trial registrationNCT03326349 . Registered 31 October 2017.

Project description:BackgroundIntegrating behavioral intervention into motor rehabilitation is essential for improving paretic arm use in daily life. Demands on therapist time limit adoption of behavioral programs like Constraint-Induced Movement (CI) therapy, however. Self-managed motor practice could free therapist time for behavioral intervention, but there remains insufficient evidence of efficacy for a self-management approach.MethodsThis completed, parallel, five-site, pragmatic, single-blind trial established the comparative effectiveness of using in-home gaming self-management as a vehicle to redirect valuable therapist time towards behavioral intervention. Community-dwelling adults with post-stroke (>6 months) mild/moderate upper extremity hemiparesis were randomized to receive one of 4 different interventions over a 3-week period: 5 h of behaviorally-focused intervention plus gaming self-management (Self-Gaming), the same with additional behaviorally-focused telerehabilitation (Tele-Gaming), 5 h of Traditional motor-focused rehabilitation, or 35 h of CI therapy. Primary outcomes assessed everyday arm use (Motor Activity Log Quality of Movement, MAL) and motor speed/function (Wolf Motor Function Test, WMFT) immediately before treatment, immediately after treatment, and 6 months later. Intent-to-treat analyses were implemented with linear mixed-effects models on data gathered from March 15, 2016 to November 21, 2019. ClinicalTrials.gov, NCT02631850.ResultsOf 193 enrolled participants, 167 began treatment and were analyzed, 150 (90%) completed treatment, and 115 (69%) completed follow-up. Tele-Gaming and Self-Gaming produced clinically meaningful MAL gains that were 1·0 points (95% CI 0·8 to 1·3) and 0·8 points (95% CI 0·5 to 1·0) larger than Traditional care, respectively. Self-Gaming was less effective than CI therapy (-0·4 points, 95% CI -0·6 to -0·2), whereas Tele-Gaming was not (-0·2 points, 95% CI -0·4 to 0·1). Six-month retention of MAL gains across all groups was 57%. All had similar clinically-meaningful WMFT gains; six-month retention of WMFT gains was 92%.InterpretationSelf-managed motor-gaming with behavioral telehealth visits has outcomes similar to in-clinic CI therapy. It addresses most access barriers, requiring just one-fifth as much therapist time that is redirected towards behavioral interventions that enhance the paretic arm's involvement in daily life.FundingPCORI, NIH.

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

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

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