Implementing functional electrical stimulation clinical practice guidelines to support mobility: A stakeholder consultation.

Functional Electrical Stimulation (FES) has been used to support mobility for people with upper motor neuron conditions such as stroke and multiple sclerosis for over 25 years. Recent development and publication of clinical practice guidelines (CPGs) provide evidence to guide clinical decision making for application of FES to improve mobility. Understanding key barriers to the implementation of these CPGs is a critical initial step necessary to create tailored knowledge translation strategies. A public involvement and engagement consultation was conducted with international stakeholders including researchers, clinicians and engineers working with FES to inform implementation strategies for CPG use internationally. Reflexive thematic analysis of the consultation transcripts revealed themes including inconsistent use of CPGs, barriers to implementation such as limited access to FES and low clinician confidence, and the need for a tiered education approach with ongoing support. Insights derived from this consultation will inform the development of knowledge translation strategies to support the next steps to implementing FES use for mobility.

Longitudinal analysis of the recovery of trunk control and upper extremity following stroke: An individual growth curve approach.

BACKGROUND AND PURPOSE: Trunk control is thought to contribute to upper extremity function. It is unclear whether recovery of trunk control has an impact on the recovery of the upper extremity in people with stroke. This longitudinal study monitored the recovery of trunk control and upper extremity in the first 6 months following stroke. METHODS: Forty-five participants with stroke were assessed monthly for 6 months following stroke. Trunk control was assessed using the Trunk Impairment Scale (TIS); upper extremity impairment and function were assessed with the Fugl-Meyer (FMA) and Streamlined Wolf Motor Function Test (SWMFT) respectively. The SWMFT included the performance time (SWMFT-Time) and functional ability scale (SWMFT-FAS). The individual growth curve modeling was used to analyze the longitudinal data. RESULTS: The recovery curve of TIS, FMA, SWMFT-Time and SWMFT-FAS followed a quadratic trend, with the rate of recovery decreasing from the first to sixth month. As TIS score improved over time, FMA, SWMFT-Time and SWMFT-FAS improved in parallel with the TIS score. TIS at each time point was found to be a significant predictor of FMA, SWMFT-Time and SWMFT-FAS at 6 months post stroke. CONCLUSION: Our work has provided, for the first time, substantial evidence that the pattern of recovery of trunk control is similar to that of the recovery of upper extremity following stroke. In addition, this study provides evidence on which to design a prospective study to evaluate whether improvement in trunk control early post-stroke results in better long-term upper extremity function.

European evidence-based recommendations for clinical assessment of upper limb in neurorehabilitation (CAULIN): data synthesis from systematic reviews, clinical practice guidelines and expert consensus.

BACKGROUND: Technology-supported rehabilitation can help alleviate the increasing need for cost-effective rehabilitation of neurological conditions, but use in clinical practice remains limited. Agreement on a core set of reliable, valid and accessible outcome measures to assess rehabilitation outcomes is needed to generate strong evidence about effectiveness of rehabilitation approaches, including technologies. This paper collates and synthesizes a core set from multiple sources; combining existing evidence, clinical practice guidelines and expert consensus into European recommendations for Clinical Assessment of Upper Limb In Neurorehabilitation (CAULIN). METHODS: Data from systematic reviews, clinical practice guidelines and expert consensus (Delphi methodology) were systematically extracted and synthesized using strength of evidence rating criteria, in addition to recommendations on assessment procedures. Three sets were defined: a core set: strong evidence for validity, reliability, responsiveness and clinical utility AND recommended by at least two sources; an extended set: strong evidence OR recommended by at least two sources and a supplementary set: some evidence OR recommended by at least one of the sources. RESULTS: In total, 12 measures (with primary focus on stroke) were included, encompassing body function and activity level of the International Classification of Functioning and Health. The core set recommended for clinical practice and research: Fugl-Meyer Assessment of Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT); the extended set recommended for clinical practice and/or clinical research: kinematic measures, Box and Block Test (BBT), Chedoke Arm Hand Activity Inventory (CAHAI), Wolf Motor Function Test (WMFT), Nine Hole Peg Test (NHPT) and ABILHAND; the supplementary set recommended for research or specific occasions: Motricity Index (MI); Chedoke-McMaster Stroke Assessment (CMSA), Stroke Rehabilitation Assessment Movement (STREAM), Frenchay Arm Test (FAT), Motor Assessment Scale (MAS) and body-worn movement sensors. Assessments should be conducted at pre-defined regular intervals by trained personnel. Global measures should be applied within 24 h of hospital admission and upper limb specific measures within 1 week. CONCLUSIONS: The CAULIN recommendations for outcome measures and assessment procedures provide a clear, simple, evidence-based three-level structure for upper limb assessment in neurological rehabilitation. Widespread adoption and sustained use will improve quality of clinical practice and facilitate meta-analysis, critical for the advancement of technology-supported neurorehabilitation.

Setting the scene for the Second Stroke Recovery and Rehabilitation Roundtable.

The Stroke Recovery and Rehabilitation Roundtable (SRRR) meetings bring together an international group of preclinical and clinical researchers along with statisticians, methodologists, funders and consumers, working to accelerate the development of effective treatments for stroke recovery and to support best-evidence uptake in rehabilitation practice. The first meeting (2016) focused on four recommendation areas: translation of preclinical evidence into human discovery trials; recovery biomarkers to provide knowledge of therapeutic targets and prognosis in human stroke; intervention development, monitoring, and reporting standards; and standardized measurement in motor recovery trials. The impact of SRRR is growing, with uptake of recommendations emerging, and funders exploring ways to incorporate research targets and recommendations. At our second meeting (SRRR2, 2018), we worked on new priority areas: (1) cognitive impairment, (2) standardizing metrics for measuring quality of movement, (3) improving development of recovery trials, and (4) moving evidence-based treatments into practice. To accelerate progress towards breakthrough treatments, formation of an International Stroke Recovery and Rehabilitation Alliance is our next step, where working groups will take recommendations and build partnerships needed to achieve our goals.

Measurement of motor-evoked potential resting threshold and amplitude of proximal and distal arm muscles in healthy adults. A reliability study.

PURPOSE: Reliability of motor-evoked potential threshold and amplitude measurement of upper limb muscles is important when detecting changes in cortical excitability. The objective of this study was to investigate intra-rater, test-retest reliability and minimal detectable change of resting motor threshold and amplitude of a proximal and distal upper limb muscles, anterior deltoid and distal extensor digitorum communis in healthy adults. METHOD: To measure motor-evoked potential responses, transcranial magnetic stimulation was interfaced with electromyography and neuronavigation equipment. Two measurements were conducted on day 1 and a third measurement three days later. Reliability was analysed using intraclass correlation coefficients. RESULTS: Twenty participants completed the study. Excellent intra-rater (intraclass correlation coefficient = 0.91 (extensor digitorum), 0.94 (anterior deltoid)) and good to excellent test-retest reliability (intraclass correlation coefficient = 0.69 (anterior deltoid), 0.84 (extensor digitorum)) was found for resting motor threshold. Minimal detectable change for resting motor threshold was found at 10.95% (extensor digitorum) and 16.35% (anterior deltoid) between first and third measurements. Motor-evoked potential amplitude of extensor digitorum communis had fair to good intra-rater (intraclass correlation coefficient = 0.50) and test-retest reliability (intraclass correlation coefficient = 0.65). CONCLUSIONS: Our results suggest that resting motor threshold is a reliable neurophysiological measure even for proximal shoulder muscles. Future research should further explore the reliability of motor-evoked potential amplitude before integration into neurological rehabilitation.

Upper limb and eye movement coordination during reaching tasks in people with stroke.

PURPOSE: To enhance understanding of the relationship between upper limb and eye movements during reaching tasks in people with stroke. METHODS: Eye movements were recorded from 10 control participants and 8 chronic stroke participants during a visual orienting task (Experiment 1) and a series of reaching tasks (Experiment 2). Stroke participants completed the reaching tasks using (i) their less impaired upper limb, (ii) their more impaired upper limb without support, and (iii) their more impaired upper limb, with support (SaeboMAS gravitational support and/or electrical stimulation). Participants were tested individually and completed both experiments in the same session. RESULTS: Oculomotor control and the coordination between the upper limb and the oculomotor system were found to be intact in stroke participants when no limb movements were required, or when the less impaired upper limb was used. However, when the more impaired upper limb was used, success and accuracy in reaching decreased and patterns of eye movements changed, with an observed increase in eye movements to the limb itself. With upper limb support, patterns of hand-eye coordination were found to more closely resemble those of the control group. CONCLUSION: Deficits in upper limb motor systems result in changes in patterns of eye movement behavior during reaching tasks. These changes in eye movement behavior can be modulated by providing upper limb support. Implications for Rehabilitation Deficits in upper limb motor systems can result in changes in patterns of eye movement behavior during reaching tasks. Upper limb support can reduce deficits in hand-eye coordination. Stroke rehabilitation outcomes should consider motor and oculomotor performance.

Telehealth, Wearable Sensors, and the Internet: Will They Improve Stroke Outcomes Through Increased Intensity of Therapy, Motivation, and Adherence to Rehabilitation Programs?

BACKGROUND AND PURPOSE: Stroke, predominantly a condition of older age, is a major cause of acquired disability in the global population and puts an increasing burden on health care resources. Clear evidence for the importance of intensity of therapy in optimizing functional outcomes is found in animal models, supported by neuroimaging and behavioral research, and strengthened by recent meta-analyses from multiple clinical trials. However, providing intensive therapy using conventional treatment paradigms is expensive and sometimes not feasible because of social and environmental factors. This article addresses the need for cost-effective increased intensity of practice and suggests potential benefits of telehealth (TH) as an innovative model of care in physical therapy. SUMMARY OF KEY POINTS: We provide an overview of TH and present evidence that a web-supported program, used in conjunction with constraint-induced therapy (CIT), can increase intensity and adherence to a rehabilitation regimen. The design and feasibility testing of this web-based program, "LifeCIT," is presented. We describe how wearable sensors can monitor activity and provide feedback to patients and therapists. The methodology for the development of a wearable device with embedded inertial and mechanomyographic sensors, algorithms to classify functional movement, and a graphical user interface to present meaningful data to patients to support a home exercise program is explained. RECOMMENDATIONS FOR CLINICAL PRACTICE: We propose that wearable sensor technologies and TH programs have the potential to provide most-effective, intensive, home-based stroke rehabilitation.

Fitness and mobility training in patients with Intensive Care Unit-acquired muscle weakness (FITonICU): study protocol for a randomised controlled trial.

BACKGROUND: Critical illness myopathy (CIM) and polyneuropathy (CIP) are a common complication of critical illness. Both cause intensive-care-unit-acquired (ICU-acquired) muscle weakness (ICUAW) which increases morbidity and delays rehabilitation and recovery of activities of daily living such as walking ability. Focused physical rehabilitation of people with ICUAW is, therefore, of great importance at both an individual and a societal level. A recent systematic Cochrane review found no randomised controlled trials (RCT), and thus no supporting evidence, for physical rehabilitation interventions for people with defined CIP and CIM to improve activities of daily living. Therefore, the aim of our study is to compare the effects of an additional physiotherapy programme with systematically augmented levels of mobilisation with additional in-bed cycling (as the parallel group) on walking and other activities of daily living. METHODS/DESIGN: We will conduct a prospective, rater-masked RCT of people with ICUAW with a defined diagnosis of CIM and/or CIP in our post-acute hospital. We will randomly assign patients to one of two parallel groups in a 1:1 ratio and will use a concealed allocation. One intervention group will receive, in addition to standard ICU treatment, physiotherapy with systematically augmented levels of mobilisation (five times per week, over 2 weeks; 20 min each session; with a total of 10 additional sessions). The other intervention group will receive, in addition to standard ICU treatment, in-bed cycle sessions (same number, frequency and treatment time as the intervention group). Standard ICU treatment includes sitting balance exercise, stretching, positioning, and sit-to-stand training, and transfer training to get out of bed, strengthening exercise (in and out of bed), and stepping and assistive standing exercises. Primary efficacy endpoints will be walking ability (defined as a Functional Ambulation Category (FAC) level of ≥3) and the sum score of the Functional Status Score for the Intensive Care Unit (FSS-ICU) (range 0-22 points) assessed by a blinded tester immediately after 2 weeks of additional therapy. Secondary outcomes will include assessment of sit-to-stand recovery, overall limb strength (Medical Research Council, MRC) and grip strength, the Physical Function for the Intensive Care Unit Test-Scored (PFIT-S), the EuroQol 5 Dimensions (EQ-5D) questionnaire and the Reintegration to Normal Living Index (RNL-Index) assessed by a blinded tester. We will measure primary and secondary outcomes with blinded assessors at baseline, immediately after 2 weeks of additional therapy, and at 3 weeks and 6 months and 12 months after the end of the additional therapy intervention. Based on our sample size calculation 108 patients will be recruited from our post-acute ICU in the next 3 to 4 years. DISCUSSION: This will be the first RCT comparing the effects of two physical rehabilitation interventions for people with ICUAW due to defined CIP and/or CIM to improve walking and other activities of daily living. The results of this trial will provide robust evidence for physical rehabilitation of people with CIP and/or CIP who often require long-term care. TRIAL REGISTRATION: We registered the study on 6 April 2016 before enrolling the first patient in the trial at the German Clinical Trials Register ( www.germanctr.de ) with the identifier DRKS00010269 . This is the first version of the protocol (FITonICU study protocol).

Recovery of sit-to-stand function in patients with intensive-care-unit-acquired muscle weakness: Results from the General Weakness Syndrome Therapy cohort study.

OBJECTIVES: To describe the time course of recovery of sit-to-stand function in patients with intensive-care-unit-acquired muscle weakness and the impact of recovery. METHODS: A cohort study in post-acute intensive care unit and rehabilitation units. Patients with chronic critical illness and intensive-care-unit-acquired muscle weakness were included. Sit-to-stand function was measured daily, using a standardized chair height, defined as 120% of the individual's knee height. RESULTS: A total of 150 patients were recruited according to the selection criteria. The primary outcome of independent sit-to-stand function was achieved by a median of 56 days (interquartile range Q1-Q3 = 32-90 days) after rehabilitation onset and a median of 113 days (Q1-Q3=70-148 days) after onset of illness. The final multivariate model for recovery of sit-to-stand function included 3 variables: age (adjusted hazard ratio (HR) = 0.96 (95% CI 0.94-0.99), duration of ventilation (HR=0.99 (95% CI 0.98-1.00) and Functional Status Score for the Intensive Care Unit (FSS-ICU) (adjusted HR=1.12 (95% CI 1.08-1.16)). CONCLUSION: Rapid recovery of sit-to-stand function for most patients with intensive-care-unit-acquired muscle weakness were seen. The variables older age and longer duration of ventilation decreased, and higher FSS-ICU increased the chance of regaining independent sit-to-stand function.

Evaluation of upper extremity neurorehabilitation using technology: a European Delphi consensus study within the EU COST Action Network on Robotics for Neurorehabilitation.

BACKGROUND: The need for cost-effective neurorehabilitation is driving investment into technologies for patient assessment and treatment. Translation of these technologies into clinical practice is limited by a paucity of evidence for cost-effectiveness. Methodological issues, including lack of agreement on assessment methods, limit the value of meta-analyses of trials. In this paper we report the consensus reached on assessment protocols and outcome measures for evaluation of the upper extremity in neurorehabilitation using technology. The outcomes of this research will be part of the development of European guidelines. METHODS: A rigorous, systematic and comprehensive modified Delphi study incorporated questions and statements generation, design and piloting of consensus questionnaire and five consensus experts groups consisting of clinicians, clinical researchers, non-clinical researchers, and engineers, all with working experience of neurological assessments or technologies. For data analysis, two major groups were created: i) clinicians (e.g., practicing therapists and medical doctors) and ii) researchers (clinical and non-clinical researchers (e.g. movement scientists, technology developers and engineers). RESULTS: Fifteen questions or statements were identified during an initial ideas generation round, following which the questionnaire was designed and piloted. Subsequently, questions and statements went through five consensus rounds over 20 months in four European countries. Two hundred eight participants: 60 clinicians (29 %), 35 clinical researchers (17 %), 77 non-clinical researchers (37 %) and 35 engineers (17 %) contributed. At each round questions and statements were added and others removed. Consensus (≥69 %) was obtained for 22 statements on i) the perceived importance of recommendations; ii) the purpose of measurement; iii) use of a minimum set of measures; iv) minimum number, timing and duration of assessments; v) use of technology-generated assessments and the restriction of clinical assessments to validated outcome measures except in certain circumstances for research. CONCLUSIONS: Consensus was reached by a large international multidisciplinary expert panel on measures and protocols for assessment of the upper limb in research and clinical practice. Our results will inform the development of best practice for upper extremity assessment using technologies, and the formulation of evidence-based guidelines for the evaluation of upper extremity neurorehabilitation.

Effect of Trunk Support on Upper Extremity Function in People With Chronic Stroke and People Who Are Healthy.

BACKGROUND: Trunk control is thought to contribute to upper extremity (UE) function. However, this common assumption in neurorehabilitation has not been validated in clinical trials. OBJECTIVE: The study objectives were to investigate the effect of providing external trunk support on trunk control and UE function and to examine the relationship between trunk control and UE function in people with chronic stroke and people who were healthy. DESIGN: A cross-sectional study was conducted. METHODS: Twenty-five people with chronic stroke and 34 people who were healthy and matched for age and sex were recruited. Trunk control was assessed with the Trunk Impairment Scale (TIS), and UE impairment and UE function were assessed with the UE subsection of the Fugl-Meyer Assessment (FMA-UE) and the Streamlined Wolf Motor Function Test (SWMFT), respectively. The TIS and SWMFT were evaluated, with and without external trunk support; the FMA-UE was evaluated without trunk support. RESULTS: With trunk support, people with stroke showed improvement from 18 to 20 points on the TIS, a reduction in SWMFT performance times from 37.20 seconds to 35.37 seconds for the affected UE, and improvement from 3.3 points to 3.4 points on the SWMFT Functional Ability Scale for the function of the affected UE. With trunk support, the SWMFT performance time for people who were healthy was reduced from 1.61 seconds to 1.48 seconds for the dominant UE and from 1.71 seconds to 1.59 seconds for the nondominant UE. A significant moderate correlation was found between the TIS and the FMA-UE (r=.53) for people with stroke. LIMITATIONS: The limitations included a nonmasked assessor and a standardized height of the external trunk support. CONCLUSIONS: External trunk support improved trunk control in people with chronic stroke and had a statistically significant effect on UE function in both people with chronic stroke and people who were healthy. The findings suggest an association between trunk control and the UE when external trunk support was provided and support the hypothesis that lower trunk and lumbar stabilization provided by external support enables an improvement in the ability to use the UE for functional activities.

The application of precisely controlled functional electrical stimulation to the shoulder, elbow and wrist for upper limb stroke rehabilitation: a feasibility study.

BACKGROUND: Functional electrical stimulation (FES) during repetitive practice of everyday tasks can facilitate recovery of upper limb function following stroke. Reduction in impairment is strongly associated with how closely FES assists performance, with advanced iterative learning control (ILC) technology providing precise upper-limb assistance. The aim of this study is to investigate the feasibility of extending ILC technology to control FES of three muscle groups in the upper limb to facilitate functional motor recovery post-stroke. METHODS: Five stroke participants with established hemiplegia undertook eighteen intervention sessions, each of one hour duration. During each session FES was applied to the anterior deltoid, triceps, and wrist/finger extensors to assist performance of functional tasks with real-objects, including closing a drawer and pressing a light switch. Advanced model-based ILC controllers used kinematic data from previous attempts at each task to update the FES applied to each muscle on the subsequent trial. This produced stimulation profiles that facilitated accurate completion of each task while encouraging voluntary effort by the participant. Kinematic data were collected using a Microsoft Kinect, and mechanical arm support was provided by a SaeboMAS. Participants completed Fugl-Meyer and Action Research Arm Test clinical assessments pre- and post-intervention, as well as FES-unassisted tasks during each intervention session. RESULTS: Fugl-Meyer and Action Research Arm Test scores both significantly improved from pre- to post-intervention by 4.4 points. Improvements were also found in FES-unassisted performance, and the amount of arm support required to successfully perform the tasks was reduced. CONCLUSIONS: This feasibility study indicates that technology comprising low-cost hardware fused with advanced FES controllers accurately assists upper limb movement and may reduce upper limb impairments following stroke.

Trunk restraint to promote upper extremity recovery in stroke patients: a systematic review and meta-analysis.

BACKGROUND: Many stroke patients exhibit excessive compensatory trunk movements during reaching. Compensatory movement behaviors may improve upper extremity function in the short-term but be detrimental to long-term recovery. OBJECTIVE: To evaluate the evidence that trunk restraint limits compensatory trunk movement and/or promotes better upper extremity recovery in stroke patients. METHODS: A search was conducted through electronic databases from January 1980 to June 2013. Only randomized controlled trials (RCTs) comparing upper extremity training with and without trunk restraint were selected for review. Three review authors independently assessed the methodological quality and extracted data from the studies. Meta-analysis was conducted when there was sufficient homogenous data. RESULTS: Six RCTs involving 187 chronic stroke patients were identified. Meta-analysis of key outcome measures showed that trunk restraint has a moderate statistically significant effect on improving Fugl-Meyer Upper Extremity (FMA-UE) score, active shoulder flexion, and reduction in trunk displacement during reaching. There was a small, nonsignificant effect of trunk restraint on upper extremity function. CONCLUSION: Trunk restraint has a moderate effect on reduction of upper extremity impairment in chronic stroke patients, in terms of FMA-UE score, increased shoulder flexion, and reduction in excessive trunk movement during reaching. There is insufficient evidence to demonstrate that trunk restraint improves upper extremity function and reaching trajectory smoothness and straightness in chronic stroke patients. Future research on stroke patients at different phases of recovery and with different levels of upper extremity impairment is recommended.

Internal and external focus of attention during gait re-education: an observational study of physical therapist practice in stroke rehabilitation.

BACKGROUND: Focus of attention is known to play an important role in motor skill learning, yet little is known about how attention is directed within the context of stroke rehabilitation. OBJECTIVE: The aims of this study were: (1) to identify physical therapists' use of internal and external focus of attention during gait rehabilitation for individuals with hemiplegia following stroke and (2) to use the findings to design an experimental study examining the impact of focus of attention on learning poststroke. DESIGN: The study design involved direct nonparticipation observation of physical therapy treatment sessions. METHODS: Eight physical therapy treatment sessions, in which gait rehabilitation was taking place, were video recorded. Patients were aged between 36 and 85 years, and ranged from 7 to 216 days poststroke; physical therapists had between 3 and 12 years of experience in stroke rehabilitation. Data analysis took 2 forms: (1) clear definitions of internal and external focus of attention were agreed on via a consensus group and used to develop an analysis matrix through which incidences of instruction and feedback were identified, categorized, and counted; and (2) verbal dialogue was transcribed verbatim and transcripts were thematically analyzed to provide a detailed description of how instructions and feedback were used, illustrated by examples. RESULTS: The use of instructions and feedback (internal and external focus) was high; an average of one verbal instruction or feedback statement was delivered every 14 seconds. Sixty-seven percent of the statements were internally focused, 22% were externally focused, and 11% were of mixed focus. Unfocused statements (eg, "good") also were used regularly. Patients were frequently encouraged to "think about" their performance. LIMITATIONS: Observational data collection methods may result in changes in the behavior of those observed, which is a potential source of bias. The small sample size also was a limitation of the study. CONCLUSION: Physical therapists frequently encouraged patients to be aware of their movements and their performance (internal focus). This approach may reduce automaticity and hinder learning and retention.

Functional electrical stimulation with exercises for standing balance and weight transfer in acute stroke patients: a feasibility randomized controlled trial.

OBJECTIVES: To test parameters needed for the design of a larger trial including the following: 1) identifying eligible participants, recruitment, and retention rates; 2) the feasibility and acceptability of delivering functional electrical stimulation (FES) to the gluteus maximus and quadriceps femoris for acute stroke patients in a hospital rehabilitation setting; 3) the outcome measures; 4) obtaining initial estimates of effect size; and 5) clarifying the relevant control group. MATERIALS AND METHODS: Twenty-one people with acute stroke-mean age = 68 (min to max: 33-87) years; weeks postonset = 4.6 (min to max: 1-14)-were randomized to three groups to receive two weeks of balance training with FES, balance training alone, or usual care. Symmetry in normal standing, weight transfer onto the affected limb, balance, mobility, and speed of walking were assessed before, shortly after the end of training, and two weeks later by a blinded assessor. RESULTS: 1) FES was successfully delivered but not with the planned eight sessions; 2) no trends in favor of FES were found; and 3) 4% of those screened took part but approaching 20% might be recruited in the future, no single outcome measure was suitable for all participants, and more routine physiotherapy was delivered to the control group. CONCLUSIONS: FES is feasible in this patient group but further feasibility and definitive trials are required.

Functional electrical stimulation mediated by iterative learning control and 3D robotics reduces motor impairment in chronic stroke.

BACKGROUND: Novel stroke rehabilitation techniques that employ electrical stimulation (ES) and robotic technologies are effective in reducing upper limb impairments. ES is most effective when it is applied to support the patients' voluntary effort; however, current systems fail to fully exploit this connection. This study builds on previous work using advanced ES controllers, and aims to investigate the feasibility of Stimulation Assistance through Iterative Learning (SAIL), a novel upper limb stroke rehabilitation system which utilises robotic support, ES, and voluntary effort. METHODS: Five hemiparetic, chronic stroke participants with impaired upper limb function attended 18, 1 hour intervention sessions. Participants completed virtual reality tracking tasks whereby they moved their impaired arm to follow a slowly moving sphere along a specified trajectory. To do this, the participants' arm was supported by a robot. ES, mediated by advanced iterative learning control (ILC) algorithms, was applied to the triceps and anterior deltoid muscles. Each movement was repeated 6 times and ILC adjusted the amount of stimulation applied on each trial to improve accuracy and maximise voluntary effort. Participants completed clinical assessments (Fugl-Meyer, Action Research Arm Test) at baseline and post-intervention, as well as unassisted tracking tasks at the beginning and end of each intervention session. Data were analysed using t-tests and linear regression. RESULTS: From baseline to post-intervention, Fugl-Meyer scores improved, assisted and unassisted tracking performance improved, and the amount of ES required to assist tracking reduced. CONCLUSIONS: The concept of minimising support from ES using ILC algorithms was demonstrated. The positive results are promising with respect to reducing upper limb impairments following stroke, however, a larger study is required to confirm this.

A personalized sensor-controlled microstimulator system for arm rehabilitation poststroke. Part 1: System architecture.

OBJECTIVES: For rehabilitation of the poststroke upper limb in seven subjects, an external sensor-based system controls the timing of five to seven microstimulators implanted near radial nerve branches or their motor points to sequentially extend the elbow, wrist, and fingers with thumb extension and abduction, enabled at the subject's own pace. We hypothesize this system will support sequential activation of affected upper limb muscles intended to improve functional recovery. MATERIALS AND METHODS: Presented here is a personalized sensor-controlled stimulation system, including its architecture, sensor design, and testing of equipment specific to this study, including coils and sensors. RESULTS: All electrical and magnetic tests, and safety tests per International Electrotechnical Commission 60601-1 passed. One sensor type displayed a vulnerability to drop. CONCLUSIONS: The new control system tested safe, met requirements, and allowed each subject to activate the system at their own pace, making the rehabilitation process more acceptable and efficient.

A personalized sensor-controlled microstimulator system for arm rehabilitation poststroke. Part 2: Objective outcomes and patients' perspectives.

OBJECTIVE: To examine the effect of home-based electrical stimulation using closed-loop control of implanted microstimulators on upper limb function and impairment, and subjects' perception of the system. MATERIALS AND METHODS: Six subjects with poststroke hemiparesis, and reduced upper limb function, who had taken part in Phase 1 of the study, were fitted with a personalized closed-loop control system (Phase 2) and used it at home during performance of functional tasks for 12 weeks (Phase 3). Main outcome measures were: Action Research Arm Test (ARAT), Fugl-Meyer upper limb assessment (FMA), and motor control (Tracking Index). Subjects' perception of the system was assessed in a structured interview. RESULTS: Improvement in ARAT (p=0.05), FMA (p=0.02), and Tracking Index (p=0.03) during Phase 3. Five subjects said using the system had changed their lives and improved their function, all performed functional tasks with the system, but external components were inconvenient. CONCLUSIONS: Closed-loop control improved in function. Subjective assessment identified that the external sensors were effective.

Upper limb stroke rehabilitation: the effectiveness of Stimulation Assistance through Iterative Learning (SAIL).

A novel system has been developed which combines robotic therapy with electrical stimulation (ES) for upper limb stroke rehabilitation. This technology, termed SAIL: Stimulation Assistance through Iterative Learning, employs advanced model-based iterative learning control (ILC) algorithms to precisely assist participant's completion of 3D tracking tasks with their impaired arm. Data is reported from a preliminary study with unimpaired participants, and also from a single hemiparetic stroke participant with reduced upper limb function who has used the system in a clinical trial. All participants completed tasks which involved moving their (impaired) arm to follow an image of a slowing moving sphere along a trajectory. The participants' arm was supported by a robot and ES was applied to the triceps brachii and anterior deltoid muscles. During each task, the same tracking trajectory was repeated 6 times and ILC was used to compute the stimulation signals to be applied on the next iteration. Unimpaired participants took part in a single, one hour training session and the stroke participant undertook 18, 1 hour treatment sessions composed of tracking tasks varying in length, orientation and speed. The results reported describe changes in tracking ability and demonstrate feasibility of the SAIL system for upper limb rehabilitation.

Potential for new technologies in clinical practice.

PURPOSE OF REVIEW: Cost-effective neurorehabilitation is essential owing to financial constraints on healthcare resources. Technologies have the potential to contribute but without strong clinical evidence are unlikely to be widely reimbursed. This review presents evidence of new technologies since 2008 and identifies barriers to translation of technologies into clinical practice. RECENT FINDINGS: Technology has not been shown to be superior to intensively matched existing therapies. Research has been undertaken into the development and preliminary clinical testing of novel technologies including robotics, electrical stimulation, constraint-induced movement therapy, assistive orthoses, noninvasive brain stimulation, virtual reality and gaming devices. Translation of the research into clinical practice has been impeded by a lack of robust evidence of clinical effectiveness and usability. Underlying mechanisms associated with recovery are beginning to be explored, which may lead to more targeted interventions. Improvements in function have been demonstrated beyond the normal recovery period, but few trials demonstrate lasting effects. SUMMARY: Technologies, alone or combined, may offer a cost-effective way to deliver intensive neurorehabilitation therapy in clinical and community environments, and have the potential to empower patients to take more responsibility for their rehabilitation and continue with long-term exercise.