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ObjectiveTo determine whether robot-assisted training is cost-effective compared with an enhanced upper limb therapy (EULT) programme or usual care.DesignEconomic evaluation within a randomised controlled trial.SettingFour National Health Service (NHS) centres in the UK: Queen’s Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust; Northwick Park Hospital, London Northwest Healthcare NHS Trust; Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde; and North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust.Participants770 participants aged 18 years or older with moderate or severe upper limb functional limitation from first-ever stroke.InterventionsParticipants randomised to one of three programmes provided over a 12-week period: robot-assisted training plus usual care; the EULT programme plus usual care or usual care.Main economic outcome measuresMean healthcare resource use; costs to the NHS and personal social services in 2018 pounds; utility scores based on EQ-5D-5L responses and quality-adjusted life years (QALYs). Cost-effectiveness reported as incremental cost per QALY and cost-effectiveness acceptability curves.ResultsAt 6 months, on average usual care was the least costly option (£3785) followed by EULT (£4451) with robot-assisted training being the most costly (£5387). The mean difference in total costs between the usual care and robot-assisted training groups (£1601) was statistically significant (p<0.001). Mean QALYs were highest for the EULT group (0.23) but no evidence of a difference (p=0.995) was observed between the robot-assisted training (0.21) and usual care groups (0.21). The incremental cost per QALY at 6 months for participants randomised to EULT compared with usual care was £74 100. Cost-effectiveness acceptability curves showed that robot-assisted training was unlikely to be cost-effective and that EULT had a 19% chance of being cost-effective at the £20 000 willingness to pay (WTP) threshold. Usual care was most likely to be cost-effective at all the WTP values considered in the analysis.ConclusionsThe cost-effectiveness analysis suggested that neither robot-assisted training nor EULT, as delivered in this trial, were likely to be cost-effective at any of the cost per QALY thresholds considered.Trial registration numberISRCTN69371850.

Issue Title: Special Issue on Rehabilitation Robotics In this paper we describe the novel concept of performance-based progressive robot therapy that uses speed, time, or EMG thresholds to initiate robot assistance. We pioneered the clinical application of robot-assisted therapy focusing on stroke--the largest cause of disability in the US. We have completed several clinical studies involving well over 200 stroke patients. Research to date has shown that repetitive task-specific, goal-directed, robot-assisted therapy is effective in reducing motor impairments in the affected arm after stroke. One research goal is to determine the optimal therapy tailored to each stroke patient that will maximize his/her recovery. A proposed method to achieve this goal is a novel performance-based impedance control algorithm, which is triggered via speed, time, or EMG. While it is too early to determine the effectiveness of the algorithm, therapists have already noted one very strong benefit, a significant reduction in arm tone.[PUBLICATION ABSTRACT]

Previous studies examining discrete movements of Parkinson’s disease (PD) patients have found that in addition to performing movements that were slower than those of control participants, they exhibit specific deficits in movement coordination and in sensorimotor integration required to accurately guide movements. With medication, movement speed was normalized, but the coordinative aspects of movement were not. This led to the hypothesis that dopaminergic medication more readily compensates for intensive aspects of movement (such as speed), than for coordinative aspects (such as coordination of different limb segments) (Schettino et al., Exp Brain Res 168:186–202, 2006 ). We tested this hypothesis on rhythmic, continuous movements of the forearm. In our task, target peak speed and amplitude, availability of visual feedback, and medication state (on/off) were varied. We found, consistent with the discrete-movement results, that peak speed (intensive aspect) was normalized by medication, while accuracy, which required coordination of speed and amplitude modulation (coordinative aspect), was not normalized by dopaminergic treatment. However, our findings that amplitude, an intensive aspect of movement, was also not normalized by medication, suggests that a simple pathway gain increase does not act to remediate all intensive aspects of movement to the same extent. While it normalized movement peak speed, it did not normalize movement amplitude. Furthermore, we found that when visual feedback was not available, all participants (PD and controls) made faster movements. The effects of dopaminergic medication and availability of visual feedback on movement speed were additive. The finding that movement speed uniformly increased both in the PD and the control groups suggests that visual feedback may be necessary for calibration of peak speed, otherwise underestimated by the motor control system.

This paper presents an overview of our research in robot-aided stroke neuro-rehabilitation and recovery. At the onset of this research we had to confront squarely (and solve!) a critical question: If anatomy is destiny, can we influence it? Our efforts over the last five years have been focused on answering this question and we will present a few of our clinical results from over 2,000 hours of robot-aided therapy with 76 stroke patients. To determine if exercise therapy influences plasticity and recovery of the brain following a stroke, we needed the appropriate \"microscope\" that would allow us to concomitantly control the amount of therapy delivered to a patient, while objectively measuring patient's performance. Back-driveable robots are the key enabling technology. Our results to date using common clinical scales suggest that robot-aided sensorimotor training does have a genuinely positive effect on reduction of impairment and the reorganization of the adult brain. Yet while clinical scales can help us to examine the impact in the neuro-recovery process, their coarse nature requires extensive and time-consuming trials, and on top of that they fail to show us details important for optimizing therapy. Alternative, robot-based scales offer the potential benefit of new finer measurements-and deeper insight into the process of recovery from neurological injury. We also plan to use present technology to establish the practicality and economic feasibility of clinician-supervised, robot-administered therapy, including classroom therapy. We feel quite optimistic that the march of progress will accelerate substantially in the near future and allow us to transfer this technology from the research realm to the everyday treatment of stroke survivors.

We have been investigating motor control and learning in parkinsonian subjects. In the current study, we sought to explore the existence of deficits in procedural motor learning, which is a form of implicit motor learning where skill improves over repetitive blocks of trials. We sought to determine, in particular, whether any such deficit is accentuated during specific types or phases of learning. We would expect that those specific learning tasks would require the greatest participation of the basal ganglia. Numerous studies have found that Parkinson's disease (PD) patients may show deficits in learning. Combined with information about basal ganglia neuronal connections and activity, this led some investigators to suggest that one of the key functions of the basal ganglia is to facilitate learning. To investigate these learning deficits, we used a robotic device to generate conservative force fields that disturbed the subjects' arm movements, thereby generating a \"virtual mechanical environment\" that subjects learned to manipulate. Movements were successively grouped into blocks comprising five different conditions: motor performance, early learning, late learning, negative transfer, and aftereffect motor performance. Our results with eight right-handed PD subjects and nine age-matched controls showed a relative decrease in the rate of learning for the PD patients in all blocks, but greater differences emerged between groups during novelty phases of learning. In particular, the difference in performance during the negative transfer condition reached statistical significance, suggesting that the basal ganglia might be a key center for \"switching\" motor patterns. Our results support the hypothesis that deficiencies in procedural motor learning are characteristic of PD. They add to existing evidence which has suggested a key role for the basal ganglia when new sensorimotor mappings are required by novel task environments. Better understanding of these deficits should facilitate the rehabilitation of PD patients.

This chapter focuses on rehabilitation robotics which can be used to augment the clinician's toolbox in order to deliver meaningful restorative therapy for an aging population, as well as on advances in orthotics to augment an individual's functional abilities beyond neurorestoration potential. The interest in rehabilitation robotics and orthotics is increasing steadily with marked growth in the last 10 years. This growth is understandable in view of the increased demand for caregivers and rehabilitation services escalating apace with the graying of the population. We provide an overview on improving function in people with a weak limb due to a neurological disorder who cannot properly control it to interact with the environment (orthotics); we then focus on tools to assist the clinician in promoting rehabilitation of an individual so that s/he can interact with the environment unassisted (rehabilitation robotics). We present a few clinical results occurring immediately poststroke as well as during the chronic phase that demonstrate superior gains for the upper extremity when employing rehabilitation robotics instead of usual care. These include the landmark VA-ROBOTICS multisite, randomized clinical study which demonstrates clinical gains for chronic stroke that go beyond usual care at no additional cost.

Loss of arm function is a common problem after stroke. Robot-assisted training might improve arm function and activities of daily living. We compared the clinical effectiveness of robot-assisted training using the MIT-Manus robotic gym with an enhanced upper limb therapy (EULT) programme based on repetitive functional task practice and with usual care. RATULS was a pragmatic, multicentre, randomised controlled trial done at four UK centres. Stroke patients aged at least 18 years with moderate or severe upper limb functional limitation, between 1 week and 5 years after their first stroke, were randomly assigned (1:1:1) to receive robot-assisted training, EULT, or usual care. Robot-assisted training and EULT were provided for 45 min, three times per week for 12 weeks. Randomisation was internet-based using permuted block sequences. Treatment allocation was masked from outcome assessors but not from participants or therapists. The primary outcome was upper limb function success (defined using the Action Research Arm Test [ARAT]) at 3 months. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN69371850. Between April 14, 2014, and April 30, 2018, 770 participants were enrolled and randomly assigned to either robot-assisted training (n=257), EULT (n=259), or usual care (n=254). The primary outcome of ARAT success was achieved by 103 (44%) of 232 patients in the robot-assisted training group, 118 (50%) of 234 in the EULT group, and 85 (42%) of 203 in the usual care group. Compared with usual care, robot-assisted training (adjusted odds ratio [aOR] 1·17 [98·3% CI 0·70–1·96]) and EULT (aOR 1·51 [0·90–2·51]) did not improve upper limb function; the effects of robot-assisted training did not differ from EULT (aOR 0·78 [0·48–1·27]). More participants in the robot-assisted training group (39 [15%] of 257) and EULT group (33 [13%] of 259) had serious adverse events than in the usual care group (20 [8%] of 254), but none were attributable to the intervention. Robot-assisted training and EULT did not improve upper limb function after stroke compared with usual care for patients with moderate or severe upper limb functional limitation. These results do not support the use of robot-assisted training as provided in this trial in routine clinical practice. National Institute for Health Research Health Technology Assessment Programme.

The aim of this study was to evaluate if the robot-mediated therapy (RMT) can yield positive outcomes in children with acquired or congenital upper extremity movement disorders. This was an uncontrolled pilot study with pre-post treatment outcome comparison carried out by the Pediatric Rehabilitation Department of a Children's Hospital. The study enrolled 12 children, aged 5 to 15 years, suffering from acquired (at least 12 months post-onset) or congenital upper limb motor impairment. 4 stroke, 6 traumatic brain injuries, and 2 hemiplegic cerebral palsy. RMT was provided 3 times a week for an hour during 6 weeks for a total of 18 robot therapy sessions. The Melbourne Scale (MS) and the upper-extremity subsection of the Fugl-Meyer Assessment (FMA) were used for measurement of impairment. Secondary outcome measurements were made through the Modified Ashworth Scale (MAS); the Reaching Performance Scale (RPS); Parent's Questionnaire, and robot-based evaluation measurements. Specifically, authors compared the smoothness, as measured by the jerk metric, and average speed of unconstrained reaching movements. Pre-post clinical evaluation revealed statistically significant gains for all primary and secondary metrics. In addition, significant improvement of robot-based metrics was observed. The primary outcome measurement mean (SEM) gains were 6.71 (1.29) for MS and 3.33 (0.80) for the FMA. RMT led to spasticity decreases in chronic cases, as shown by the reduction of MAS. It led to improved trunk-upper extremity postural attitude as demonstrated by improved RPS, and it was well accepted by parents and children as observed in the Parent's Questionnaire. This study suggests that RMT may hold rehabilitative benefits in children suffering from acquired and congenital hemiparesis.

Robot-aids or Rehabilitators are our chosen neologism to name a new class of robotic devices that represent a substantially departure from prior applications of robotics in rehabilitation. Rather than use robotics as an assistive technology for a disabled individual, we envision robots and computers as supporting and enhancing the productivity of clinicians in their efforts to facilitate a disabled individual's recovery. In this paper, we attempt a brief overview of our work in what promises to be a ground breaking field. We discuss the concept of robot-aided neuro-rehabilitation as a means to deliver therapy, measure patient performance, and also as a design tool. To illustrate the broad spectrum of neurological diseases that this technology might impact, we will illustrate each case with a different pathology, namely cerebral vascular accident (CVA – also known as stroke), Parkinson's disease (PD), and cerebral palsy (CP).

Segmentation of apparently continuous movement has been reported for over a century by human movement researchers, but the existence of primitive submovements has never been proved. In 20 patients recovering from a single cerebral vascular accident (stroke), we identified the apparent submovements that composed a continuous arm motion in an unloaded task. Kinematic analysis demonstrated a submovement speed profile that was invariant across patients with different brain lesions and provided experimental verification of the detailed shape of primitive submovements. The submovement shape was unaffected by its peak speed, and to test further the invariance of shape with speed, we analyzed movement behavior in a patient with myoclonus. This patient occasionally made involuntary shocklike arm movements, which occurred near the maximum capacity of the neuromuscular system, exhibited speed profiles that were comparable to those identified in stroke patients, and were also independent of speed.