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Eligibility Screening for an Early Upper Limb Stroke Rehabilitation Study.

ABSTRACT: Introduction: Stroke rehabilitation should start early in order to optimize patients' outcomes, but most trials include subacute or chronic patients. Although suggested that early stroke rehabilitation trials face difficulties regarding patient recruitment with corresponding low recruitment rates, no systematically collected information regarding screening and associated costs has been published. Such knowledge is essential for optimizing enrollment. Therefore, this study evaluated screening procedures for an early upper limb rehabilitation study including first-ever ischemic stroke patients <48 h after onset. Methods: Screening data for a monocentric longitudinal observational cohort study was prospectively collected. Researchers screened health-care records, during the morning round and face-to-face at the stroke-unit on working days. Outcomes were the recruitment rate, reasons for non-enrollment, and screening costs. Results: Over 15 months, 27 out of 845 screened ischemic stroke patients were enrolled, equaling a recruitment rate of 1.8/month. Main reasons for non-enrollment were no upper limb paresis (N = 456), >48 h post-stroke (N = 257), general comorbidity (N = 150), unable to follow commands (N = 148), and recurrent stroke (N = 146). Four patients were missed due to time constraints of the personnel or patient. The recruitment rate would have been 1.2 higher if also patients with recurrent strokes but without residual motor deficits or pre-stroke mRS ?2 were considered eligible. Screening costed € 7.48 per patient. Discussion: Screening at working days is sufficient to enroll patients in early stroke rehabilitation trials. Inclusion criteria regarding recurrent strokes should be less stringent to boost recruitment rates without increasing bias. Multicenter collaborations are needed to finish well-powered early stroke rehabilitation studies within a reasonable time. Ethics and Study Registration: Authorization from the local ethical committee was not required, as this study does not fall within the scope of the Human Research Act (BASEC Identifier: Req-2017-00844). The project was registered at http://www.clinicaltrials.gov (Identifier: NCT03633422).

SUBMITTER: Held JPO

PROVIDER: S-EPMC6614516 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Eligibility Screening for an Early Upper Limb Stroke Rehabilitation Study.

Held Jeremia P O JPO van Duinen Jannie J Luft Andreas R AR Veerbeek Janne M JM

Frontiers in neurology 20190702

<b>Introduction:</b> Stroke rehabilitation should start early in order to optimize patients' outcomes, but most trials include subacute or chronic patients. Although suggested that early stroke rehabilitation trials face difficulties regarding patient recruitment with corresponding low recruitment rates, no systematically collected information regarding screening and associated costs has been published. Such knowledge is essential for optimizing enrollment. Therefore, this study evaluated screen ...[more]

PMID: 31312170

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Project description:BackgroundAction observation (AO) is a physical rehabilitation approach that facilitates the occurrence of neural plasticity through the activation of the mirror-neural system, promoting motor recovery in people with stroke.ObjectivesTo assess whether AO enhances upper limb motor function in people with stroke.Search methodsWe searched the Cochrane Stroke Group Trials Register (last searched 18 May 2021), the Cochrane Central Register of Controlled Trials (18 May 2021), MEDLINE (1946 to 18 May 2021), Embase (1974 to 18 May 2021), and five additional databases. We also searched trial registries and reference lists.Selection criteriaRandomized controlled trials (RCTs) of AO alone or associated with physical practice in adults after stroke. The primary outcome was upper limb (arm and hand) motor function. Secondary outcomes included dependence on activities of daily living (ADL), motor performance, cortical activation, quality of life, and adverse effects.Data collection and analysisTwo review authors independently selected trials according to the predefined inclusion criteria, extracted data, assessed risk of bias using RoB 1, and applied the GRADE approach to assess the certainty of the evidence. The reviews authors contacted trial authors for clarification and missing information.Main resultsWe included 16 trials involving 574 individuals. Most trials provided AO followed by the practice of motor actions. Training varied between 1 day and 8 weeks of therapy, 10 to 90 minutes per session. The time of AO ranged from 1 minute to 10 minutes for each motor action, task or movement observed. The total number of motor actions ranged from 1 to 3. Control comparisons included sham observation, physical therapy, and functional activity practice.Primary outcomesAO improved arm function (standardized mean difference (SMD) 0.39, 95% confidence interval (CI) 0.17 to 0.61; 11 trials, 373 participants; low-certainty evidence); and improved hand function (mean difference (MD) 2.76, 95% CI 1.04 to 4.49; 5 trials, 178 participants; low-certainty evidence).Secondary outcomesAO did not improve ADL performance (SMD 0.37, 95% CI -0.34 to 1.08; 7 trials, 302 participants; very low-certainty evidence), or quality of life (MD 5.52, 95% CI -30.74 to 41.78; 2 trials, 30 participants; very low-certainty evidence). We were unable to pool the other secondary outcomes (motor performance and cortical activation). Only two trials reported adverse events without significant adverse effects.Authors' conclusionsThe effects of AO are small for arm function compared to any control group; for hand function the effects are large, but not clinically significant. For both, the certainty of evidence is low. There is no evidence of benefit or detriment from AO on ADL and quality of life of people with stroke; however, the certainty of evidence is very low. As such, our confidence in the effect estimate is limited because it will likely change with future research.

Project description:Introduction Robotic therapy allow to propose sessions of controlled and identical exercises, customizing settings, and characteristics on the individual patient. The effectiveness of robotic assisted therapy is still under study and the use of robots in clinical practice is still limited. Moreover, the possibility of treatment at home allows to reduce the economic costs and time to be borne by the patient and the caregiver and is a valid tool during periods of pandemic such as covid. The aim of this study is to assess whether a robotic home-based treatment rehabilitation using the iCONE robotic device has effects on a stroke population, despite the chronic condition of patients involved and the absence of a therapist next to the patient while performing the exercises. Materials and methods All patients underwent an initial (T0) and final (T1) assessment with the iCONE robotic device and clinical scales. After T0 evaluation, the robot was delivered to the patient's home for 10 days of at-home treatment (5 days a week for 2 weeks). Results Comparison between T0 and T1 evaluations revealed some significant improvements in robot-evaluated indices such as Independence and Size for the Circle Drawing exercise and Movement Duration for Point-to-Point exercise, but also in the MAS of the elbow. From the analysis of the acceptability questionnaire, a general appreciation of the robot emerged: patients spontaneously asked for the addition of further sessions and to continue therapy. Discussion Telerehabilitation of patients suffering from a chronic stroke is an area that is still little explored. From our experience, this is one of the first studies to carry out a telerehabilitation with these characteristics. The use of robots can become a method to reduce the rehabilitation health costs, to ensure continuity of care, and to arrive in more distant places or where the availability of resources is limited. Conclusion From the data obtained, this rehabilitation seems to be promising for this population. Moreover, promoting the recovery of the upper limb, iCONE can improve patient's quality of life. It would be interesting to conduct RCT studies to compare a conventional treatment in structure with a robotic telematics treatment.

Project description:Stroke is the primary cause of adult disability. To support this large population in recovery, robotic technologies are being developed to assist in the delivery of rehabilitation. This paper presents an automated system for a rehabilitation robotic device that guides stroke patients through an upper-limb reaching task. The system uses a decision theoretic model (a partially observable Markov decision process, or POMDP) as its primary engine for decision making. The POMDP allows the system to automatically modify exercise parameters to account for the specific needs and abilities of different individuals, and to use these parameters to take appropriate decisions about stroke rehabilitation exercises.The performance of the system was evaluated by comparing the decisions made by the system with those of a human therapist. A single patient participant was paired up with a therapist participant for the duration of the study, for a total of six sessions. Each session was an hour long and occurred three times a week for two weeks. During each session, three steps were followed: (A) after the system made a decision, the therapist either agreed or disagreed with the decision made; (B) the researcher had the device execute the decision made by the therapist; (C) the patient then performed the reaching exercise. These parts were repeated in the order of A-B-C until the end of the session. Qualitative and quantitative question were asked at the end of each session and at the completion of the study for both participants.Overall, the therapist agreed with the system decisions approximately 65% of the time. In general, the therapist thought the system decisions were believable and could envision this system being used in both a clinical and home setting. The patient was satisfied with the system and would use this system as his/her primary method of rehabilitation.The data collected in this study can only be used to provide insight into the performance of the system since the sample size was limited. The next stage for this project is to test the system with a larger sample size to obtain significant results.

Project description:BackgroundApproximately two thirds of stroke survivors maintain upper limb (UL) impairments and few among them attain complete UL recovery 6 months after stroke. Technological progress and gamification of interventions aim for better outcomes and constitute opportunities in self- and tele-rehabilitation.ObjectivesOur objective was to assess the efficacy of serious games, implemented on diverse technological systems, targeting UL recovery after stroke. In addition, we investigated whether adherence to neurorehabilitation principles influenced efficacy of games specifically designed for rehabilitation, regardless of the device used.MethodThis systematic review was conducted according to PRISMA guidelines (PROSPERO registration number: 156589). Two independent reviewers searched PubMed, EMBASE, SCOPUS and Cochrane Central Register of Controlled Trials for eligible randomized controlled trials (PEDro score ≥ 5). Meta-analysis, using a random effects model, was performed to compare effects of interventions using serious games, to conventional treatment, for UL rehabilitation in adult stroke patients. In addition, we conducted subgroup analysis, according to adherence of included studies to a consolidated set of 11 neurorehabilitation principles.ResultsMeta-analysis of 42 trials, including 1760 participants, showed better improvements in favor of interventions using serious games when compared to conventional therapies, regarding UL function (SMD = 0.47; 95% CI = 0.24 to 0.70; P < 0.0001), activity (SMD = 0.25; 95% CI = 0.05 to 0.46; P = 0.02) and participation (SMD = 0.66; 95% CI = 0.29 to 1.03; P = 0.0005). Additionally, long term effect retention was observed for UL function (SMD = 0.42; 95% CI = 0.05 to 0.79; P = 0.03). Interventions using serious games that complied with at least 8 neurorehabilitation principles showed better overall effects. Although heterogeneity levels remained moderate, results were little affected by changes in methods or outliers indicating robustness.ConclusionThis meta-analysis showed that rehabilitation through serious games, targeting UL recovery after stroke, leads to better improvements, compared to conventional treatment, in three ICF-WHO components. Irrespective of the technological device used, higher adherence to a consolidated set of neurorehabilitation principles enhances efficacy of serious games. Future development of stroke-specific rehabilitation interventions should further take into consideration the consolidated set of neurorehabilitation principles.

Project description:BACKGROUND:Effective poststroke motor rehabilitation depends on repeated limb practice with voluntary efforts. An electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-robot arm was designed for the multi-joint physical training on the elbow, the wrist, and the fingers. OBJECTIVES:To investigate the training effects of the device-assisted approach on subacute stroke patients and to compare the effects with those achieved by the traditional physical treatments. METHOD:This study was a pilot randomized controlled trial with a 3-month follow-up. Subacute stroke participants were randomly assigned into two groups, and then received 20-session upper limb training with the EMG-driven NMES-robotic arm (NMES-robot group, n?=?14) or the time-matched traditional therapy (the control, n?=?10). For the evaluation of the training effects, clinical assessments including Fugl-Meyer Assessment (FMA), Modified Ashworth Score (MAS), Action Research Arm Test (ARAT), and Function Independence Measurement (FIM) were conducted before, after the rehabilitation training, and 3?months later. Session-by-session EMG parameters in the NMES-robot group, including normalized co-contraction Indexes (CI) and EMG activation level of target muscles, were used to monitor the progress in muscular coordination patterns. RESULTS:Significant improvements were obtained in FMA (full score and shoulder/elbow), ARAT, and FIM [P?<?0.001, effect sizes (EFs)?>?0.279] for both groups. Significant improvement in FMA wrist/hand was only observed in the NMES-robot group (P?<?0.001, EFs?=?0.435) after the treatments. Significant reduction in MAS wrist was observed in the NMES-robot group after the training (P?<?0.05, EFs?=?0.145) and the effects were maintained for 3?months. MAS scores in the control group were elevated following training (P?<?0.05, EFs?>?0.24), and remained at an elevated level when assessed 3?months later. The EMG parameters indicated a release of muscle co-contraction in the muscle pairs of biceps brachii and flexor carpi radialis and biceps brachii and triceps brachii, as well as a reduction of muscle activation level in the wrist flexor in the NMES-robot group. CONCLUSION:The NMES-robot-assisted training was effective for early stroke upper limb rehabilitation and promoted independence in the daily living comparable to the traditional physical therapy. It could achieve higher motor outcomes at the distal joints and more effective release in muscle tones than the traditional therapy. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, identifier NCT02117089; date of registration: April 10, 2014.

Project description:Upper limb motor deficits in severe stroke survivors often remain unresolved over extended time periods. Novel neurotechnologies have the potential to significantly support upper limb motor restoration in severely impaired stroke individuals. Here, we review recent controlled clinical studies and reviews focusing on the mechanisms of action and effectiveness of single and combined technology-aided interventions for upper limb motor rehabilitation after stroke, including robotics, muscular electrical stimulation, brain stimulation and brain computer/machine interfaces. We aim at identifying possible guidance for the optimal use of these new technologies to enhance upper limb motor recovery especially in severe chronic stroke patients. We found that the current literature does not provide enough evidence to support strict guidelines, because of the variability of the procedures for each intervention and of the heterogeneity of the stroke population. The present results confirm that neurotechnology-aided upper limb rehabilitation is promising for severe chronic stroke patients, but the combination of interventions often lacks understanding of single intervention mechanisms of action, which may not reflect the summation of single intervention's effectiveness. Stroke rehabilitation is a long and complex process, and one single intervention administrated in a short time interval cannot have a large impact for motor recovery, especially in severely impaired patients. To design personalized interventions combining or proposing different interventions in sequence, it is necessary to have an excellent understanding of the mechanisms determining the effectiveness of a single treatment in this heterogeneous population of stroke patients. We encourage the identification of objective biomarkers for stroke recovery for patients' stratification and to tailor treatments. Furthermore, the advantage of longitudinal personalized trial designs compared to classical double-blind placebo-controlled clinical trials as the basis for precise personalized stroke rehabilitation medicine is discussed. Finally, we also promote the necessary conceptual change from 'one-suits-all' treatments within in-patient clinical rehabilitation set-ups towards personalized home-based treatment strategies, by adopting novel technologies merging rehabilitation and motor assistance, including implantable ones.

Dataset Information

Eligibility Screening for an Early Upper Limb Stroke Rehabilitation Study.

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Eligibility Screening for an Early Upper Limb Stroke Rehabilitation Study.

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