Maybe a protocol could be written on this but I can't figure it out.
A comparison of the effects and usability of two exoskeletal robots with and without robotic actuation for upper extremity rehabilitation among patients with stroke: a single-blinded randomised controlled pilot study
Journal of NeuroEngineering and Rehabilitation volume 17, Article number: 137 (2020)
Abstract
Background
Robotic rehabilitation of stroke survivors with upper extremity dysfunction may yield different outcomes depending on the robot type. Considering that excessive dependence on assistive force by robotic actuators may interfere with the patient’s active learning and participation, we hypothesised that the use of an active-assistive robot with robotic actuators does not lead to a more meaningful difference with respect to upper extremity rehabilitation than the use of a passive robot without robotic actuators. Accordingly, we aimed to evaluate the differences in the clinical and kinematic outcomes between active-assistive and passive robotic rehabilitation among stroke survivors.
Methods
In this single-blinded randomised controlled pilot trial, we assigned 20 stroke survivors with upper extremity dysfunction (Medical Research Council scale score, 3 or 4) to the active-assistive robotic intervention (ACT) and passive robotic intervention (PSV) groups in a 1:1 ratio and administered 20 sessions of 30-min robotic intervention (5 days/week, 4 weeks). The primary (Wolf Motor Function Test [WMFT]-score and -time: measures activity), and secondary (Fugl-Meyer Assessment [FMA] and Stroke Impact Scale [SIS] scores: measure impairment and participation, respectively; kinematic outcomes) outcome measures were determined at baseline, after 2 and 4 weeks of the intervention, and 4 weeks after the end of the intervention. Furthermore, we evaluated the usability of the robots through interviews with patients, therapists, and physiatrists.
Results
In both the groups, the WMFT-score and -time improved over the course of the intervention. Time had a significant effect on the WMFT-score and -time, FMA-UE, FMA-prox, and SIS-strength; group × time interaction had a significant effect on SIS-function and SIS-social participation (all, p < 0.05). The PSV group showed better improvement in participation and smoothness than the ACT group. In contrast, the ACT group exhibited better improvement in mean speed.
Conclusions
There were no differences between the two groups regarding the impairment and activity domains. However, the PSV robots were more beneficial than ACT robots regarding participation and smoothness. Considering the high cost and complexity of ACT robots, PSV robots might be more suitable for rehabilitation in stroke survivors capable of voluntary movement.
Trial registration The trial was registered retrospectively on 14 March 2018 at ClinicalTrials.gov (NCT03465267).
Introduction
Approximately 30–66% of stroke survivors suffer from upper extremity dysfunction, which leads to impediment of activities of daily living (ADL) and social participation [1]. Various interventions have been applied for upper extremity rehabilitation, and robotic rehabilitation has been recently popularised [2,3,4].
Robotic rehabilitation has potential advantages regarding the high repetition of specific tasks and interactivity, leading to active participation with less burden on therapists [2, 5]. Recent systematic reviews have suggested the beneficial effects of robotic rehabilitation on upper extremity dysfunction among patients with stroke [4, 6]. Veerbeek et al. described that robotic rehabilitation is more beneficial for the improvement of the motor control and strength of a paretic arm, but not for that of ADL, than is conventional therapy [6]. Furthermore, Mehrholz et al. demonstrated that robotic rehabilitation has more beneficial effects on ADL as well as on arm function and muscle strength compared to conventional therapy [4]. However, these conclusions should be considered cautiously because the robots that were included in these reviews were heterogenous: 28 and 24 different rehabilitation robots were included in the systemic reviews by Veerbeek et al. and Mehrholz et al., respectively. We recently showed that the use of end-effector and exoskeleton rehabilitation robots led to significant functional outcome differences stemming from distinct characteristics of the robots; this indicates that the differential effects might result from the inherent characteristics of the rehabilitation robot that was used [7]. In addition to the structural difference, the type of robotic control architecture (e.g., position, force, and impedance control) or robotic actuation (e.g., hydraulic power, pneumatic, and electric motor actuation) could also affect the therapeutic outcome [8, 9]. Nonetheless, there is a lack of studies that examined the differential effects according to the characteristics of robots. If the discrepant effects during upper extremity rehabilitation are understood according to the characteristics of robots, more suitable robotic rehabilitation may be applied and provided to each patient.
Accordingly, robotic devices can be classified as active-assistive and passive robotic devices according to the training modality. A passive robot does not provide assistive force, while an active-assistive robot provides assistive force with robotic actuators when the user is unable to make active movements [10,11,12]. Robotic active assistance is thought to be beneficial for users without voluntary movement because they can be trained with according to an ideal path or speed. Nonetheless, active assistance using manipulation for upper limb rehabilitation is too complex to be adopted with ease because the upper extremities are composed of several joints and different muscles, which allow movements with multiple degrees of freedom. Moreover, musculoskeletal problems associated with stroke such as spasticity, contractures, deformity, or hemiplegic shoulder pain make the application of robotic assistance more difficult. Additionally, excessive dependence on assistive force might interfere with active learning and participation for users who can perform voluntary movement. Therefore, we hypothesised that an active-assistive robot does not make a meaningful difference in terms of upper extremity rehabilitation relative to that made by a passive robot. Thus, we aimed to explore whether there is a difference in clinical and kinematic outcomes between active-assistive and passive robots during robot-assisted upper extremity rehabilitation of patients with stroke showing a Medical Research Council (MRC) scale score of 3 or 4 for the paretic proximal upper limb. In addition, we assessed the usability of robotic assistance. To our knowledge, this is the first clinical trial to directly compare rehabilitative effects between active-assistive and passive robots.
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