I wish they would say in exact words; 'This failed at 100% recovery, we don't have any clue how to get you recovered.' I hate the term, non-inferior, fucking wishy-washy word.
Neurocognitive robot-assisted rehabilitation of hand function: a randomized control trial on motor recovery in subacute stroke
Journal of NeuroEngineering and Rehabilitation volume 17, Article number: 115 (2020)
Abstract
Background
Hand function is often impaired after stroke, strongly affecting the ability to perform daily activities. Upper limb robotic devices have been developed to complement rehabilitation therapy offered to persons who suffered a stroke, but they rarely focus on the training of hand sensorimotor function. The primary goal of this study was to evaluate whether robot-assisted therapy of hand function following a neurocognitive approach (i.e., combining motor training with somatosensory and cognitive tasks) produces an equivalent decrease in upper limb motor impairment compared to dose-matched conventional neurocognitive therapy, when embedded in the rehabilitation program of inpatients in the subacute stage after stroke.
Methods
A parallel-group, randomized controlled trial was conducted on subjects with subacute stroke receiving either conventional or robot-assisted neurocognitive hand therapy using a haptic device. Therapy was provided for 15, 45-min sessions over four weeks, nested within the standard therapy program. Primary outcome was the change from baseline in the upper extremity part of the Fugl-Meyer Assessment (FMA-UE) after the intervention, which was compared between groups using equivalence testing. Secondary outcome measures included upper limb motor, sensory and cognitive assessments, delivered therapy dose, as well as questionnaires on user technology acceptance.
Results
Thirty-three participants with stroke were enrolled. 14 subjects in the robot-assisted and 13 subjects in the conventional therapy group completed the study. At the end of intervention, week 8 and week 32, the robot-assisted/conventional therapy group improved by 7.14/6.85, 7.79/7.31, and 8.64/8.08 points on the FMA-UE, respectively, establishing that motor recovery in the robot-assisted group is non-inferior to that in the control group.
Conclusions
Neurocognitive robot-assisted therapy of hand function allows for a non-inferior motor recovery compared to conventional dose-matched neurocognitive therapy when performed during inpatient rehabilitation in the subacute stage. This allows the early familiarization of subjects with stroke to the use of such technologies, as a first step towards minimal therapist supervision in the clinic, or directly at home after hospital discharge, to help increase the dose of hand therapy for persons with stroke.
Trial registration
EUDAMED database (CIV-13-02-009921), clinicaltrials.gov (NCT02096445). Registered 26 March 2014 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02096445
Background
Upper-limb robot-assisted therapy has been established as a safe and feasible treatment to complement rehabilitation after neurological injury, such as stroke [1]. Robots can precisely control the interaction with the user (e.g., supporting or resisting in an assist-as-needed manner) and render virtual environments both visually and mechanically, making them ideal tools for sensorimotor training, providing engaging and challenging therapy [2, 3]. Over the past two decades, several robotic devices to train the proximal upper extremity [4] were developed and clinically evaluated, achieving outcomes comparable to dose-matched conventional therapy [1,2,3, 5,6,7,8,9,10].
However, distal arm function is essential for the execution of activities of daily living (e.g., eating, dressing) and is often severely impaired after stroke [11], with low probability of regaining its full functional use [12]. Several studies have shown that functional motor training at the level of the hand with robotic devices can be beneficial and positively translate into recovery of proximal arm function [13, 14]. Despite recent investigations to develop novel robots to train hand function [9, 15, 16], only few systems took advantage of the haptic rendering capabilities of robots to support somatosensory training, nor evaluated this in clinical trials. As such, most systems for robot-assisted therapy developed to date focus on movement practice without incorporating an established therapy concept adapted to the capabilities of the respective technology.
In this work, the clinical equivalence of sensorimotor, robot-assisted rehabilitation of hand function is investigated within a four-week randomized controlled trial (RCT) on subacute stroke participants. The neurocognitive rehabilitation method proposed by Perfetti [17] was selected as reference therapy approach. It focuses on the training of sensorimotor functions as well as cognition, which is fundamental during functional interactions between body and environment (e.g., information perception, as well as elaboration, selection and execution of motor plans) [18,19,20]. Because of the relevance of the cognitive processing of sensory inputs, this approach is particularly interesting for hand rehabilitation. Moreover, the integration of multisensory inputs promotes the involvement of associative cortices that play a key role in learning and consequently in neuronal plasticity and recovery [21]. While only a few studies compared neurocognitive therapy to other rehabilitative approaches [18, 22], some promising work suggested that it can significantly improve upper-limb function, ability to perform activities of daily living and quality of life compared to conventional task-oriented training [22]. Consequently, this approach has recently found increasing interest in the scientific community, applied both in conventional [23,24,25] and in technology-assisted therapy [26, 27], but has so far not been evaluated in the context of a robot-assisted RCT. The therapy concept inspired by the neurocognitive approach was implemented on a high-fidelity 2 degrees of freedom end-effector haptic device to train hand function (i.e., the ReHapticKnob [28]). The therapy exercises focused on grasping and pronosupination (e.g., tactile discrimination tasks, teach and reproduce tasks, haptic exploration tasks, [29]) and were performed using virtual objects rendered both visually and haptically by the robot, mimicking the physical objects used in conventional therapy. The primary objective of this RCT was to investigate if the implemented robot-assisted hand therapy concept could be integrated into the rehabilitation program of participants with subacute stroke during their inpatient stay (i.e., replace one conventional neurocognitive therapy session on each intervention day) and if, at precisely matched dose, an equivalent reduction in upper limb motor impairment could be achieved. This study design was motivated by the need to establish non-inferiority in terms of rehabilitation outcomes when comparing the proposed intervention to conventional neurocognitive therapy. This is an important first step towards the investigation of more specific robot-assisted protocols that could further take advantage of the abilities of the robotic device, such as increasing dose through semi-supervised therapy. As secondary objectives, we hypothesized that neurocognitive robot-assisted therapy of the hand would lead to improvements in motor, sensory and cognitive functions in participants with subacute stroke.
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