Well then write it up as a proposed protocol and deliver it all 10 million yearly stroke survivors now and into the future. Your responsibility since we have
fucking failures of stroke associations that can't even mange to do this simple thing for survivors. But then most stroke associations are not for survivors, they are to remove money from them and supposedly train doctors.
Evidence of neuroplasticity with robotic hand exoskeleton for post-stroke rehabilitation: a randomized controlled trial
Journal of NeuroEngineering and Rehabilitation volume 18, Article number: 76 (2021)
Abstract
Background
A novel electromechanical robotic-exoskeleton was designed in-house for the rehabilitation of wrist joint and Metacarpophalangeal (MCP) joint.
Objective
The objective was to compare the rehabilitation effectiveness (clinical-scales and neurophysiological-measures) of robotic-therapy training sessions with dose-matched conventional therapy in patients with stroke.
Methods
A pilot prospective parallel randomized controlled study at clinical settings was designed for patients with stroke within 2 years of chronicity. Patients were randomly assigned to receive an intervention of 20 sessions of 45 min each, five days a week for four weeks, in Robotic-therapy Group (RG) (n = 12) and conventional upper-limb rehabilitation in Control-Group (CG) (n = 11). We intended to evaluate the effects of a novel exoskeleton based therapy on the functional rehabilitation outcomes of upper-limb and cortical-excitability in patients with stroke as compared to the conventional-rehabilitation. Clinical-scales– Modified Ashworth Scale, Active Range of Motion, Barthel-Index, Brunnstrom-stage and Fugl-Meyer (FM) scale and neurophysiological measures of cortical-excitability (using Transcranial Magnetic Stimulation) –Motor Evoked Potential and Resting Motor threshold, were acquired pre- and post-therapy.
Results
No side effects were noticed in any of the patients. Both RG and CG showed significant (p < 0.05) improvement in all clinical motor-outcomes except Modified Ashworth Scale in CG. RG showed significantly (p < 0.05) higher improvement over CG in Modified Ashworth Scale, Active Range of Motion and Fugl-Meyer scale and FM Wrist-/Hand component. An increase in cortical-excitability in ipsilesional-hemisphere was found to be statistically significant (p < 0.05) in RG over CG, as indexed by a decrease in Resting Motor Threshold and increase in the amplitude of Motor Evoked Potential. No significant changes were shown by the contralesional-hemisphere. Interhemispheric RMT-asymmetry evidenced significant (p < 0.05) changes in RG over CG indicating increased cortical-excitability in ipsilesional-hemisphere along with interhemispheric changes.
Conclusion
Robotic-exoskeleton training showed improvement in motor outcomes and cortical-excitability in patients with stroke. Neurophysiological changes in RG could most likely be a consequence of plastic reorganization and use-dependent plasticity.
Trial registry number: ISRCTN95291802
Introduction
Stroke is one of the leading causes of mortality and morbidity worldwide [1]. Flexor hypertonia of the wrist is one of its common presentations. Post-stroke, the ability to actively initiate extension movement at the wrist and fingers is one of the indicators of the motor recovery [2, 3]. Regaining hand function and Activities of daily living (ADL) is particularly impervious to therapy owing to fine motor control needed for the distal-joints [4]. Conventional rehabilitation therapy is time taking, labor-intensive and subjective. Therapists usually have a high clinical load and a lack of evidence-based technologies to support them, resulting in therapist burnout and a healthcare system that cannot provide appropriate or effective rehabilitation services [5].
Although rehabilitation with neuro-rehabilitation robots has shown encouraging clinical results [5,6,7,8,9,10,11,12,13,14,15,16,17,18], it is currently limited to a very few hospitals and not widely used because of the associated high-cost and an infrastructural-requirement to station these large and complex devices with a high set-up time and limited usability [19,20,21]. Rehabilitation strategies need to take into account the multifaceted nature of the disability, which is self-changing (progressing or improving), i.e. itself changes with time and requires a multimodal approach. Hence, the assistive device needs to be flexible and adaptive enough to accommodate the needs of a large patient population.
An effective rehabilitation device for the upper-limb should be able to facilitate a specific pattern of coordinated movements of joints, especially for a hand. However, this particular coordination is currently not integrated with any of the commercially available devices, where they mostly focus on movements of the specific individual joint in isolation [22]. For a healthy subject, extending the wrist naturally leads to flexion of the fingers. Semi-extension of the wrist with grasped fingers contributes to ADL movements; which is also commonly disrupted in patients with stroke due to flexor hypertonia. These complex movement patterns have been disintegrated during conventional physiotherapy into few simpler tasks, for example, holding a glass of water consists of sub-tasks like grasping the glass with the fingers in the motion of flexion while wrist in 30–40 degree semi-extended position, and releasing it with fingers being in extension and wrist coming back to the neutral position with flexion as elaborated in [23]. Hence, a device that can simulate the movement pattern of wrist extension along with finger flexion (such as in ADL), maintaining inter-joint coordination with the limited number of actuators making the device less complex, is the need of the hour. Only two devices, Hand Mentor and HWARD, allow hand and wrist synchronization [24]. The Hand Mentor Pro rotates wrist with Metacarpophalengeal (MCP) placed at a constant angle with respect to the wrist, but lacks flexion (grasp) and extension (release) of MCP, also it can’t accommodate patient-centric ROM and speed. Though HWARD synchronized wrist and MCP and provided seminal evidence of reorganization of the brain through robotic-therapy sessions, it had few other challenges such as limited range of motion, no patient-centric muscle-specific training, finger opening requirement, manual adjustment of force at pneumatic cylinders and device having ~ 25 kg of weight. Hence, the challenges remained to simplify the complex design and therapy protocols into simple, lightweight, user-friendly devices that are convenient with a potential to use even in home-settings. Moreover, the device must show efficacy for a broader community while being cost-effective for low and middle-income countries with limited research on rehabilitation [25,26,27]. Our device attempt to address the key limitations which other commercial devices faced.
In our previous work, we have designed a robotic hand exoskeleton for rehabilitation of the wrist and MCP joint, to synchronize wrist extension with finger-flexion and wrist-flexion with finger extension [28]. It is a prototype device with the potential of being simple and easy to operate exoskeleton rehabilitation device for low-resource settings in the future. The exoskeleton targets spasticity through a synergy-based rehabilitation approach while also maintaining patient-initiated therapy through residual muscle activity for maximizing voluntary effort. The lightweight and portable device indicated an improvement in quantitative motor clinical outcomes in patients with chronic stroke [28].
The aim of the present study was twofold. The first objective was to assess the clinical effectiveness of the novel robotic-exoskeleton device [28] and the second is a comparison of its clinical effectiveness with conventional upper-limb rehabilitation. There is a considerable amount of literature documented for neurorehabilitation robots that takes into account the specific, repetitive, and timed movement goals [29] with maximizing voluntary residual muscle activity, real-time visual performance biofeedback, and proprioceptive feedback for sensorimotor integration. These features might give the robotic-therapy a notch over dose-matched conventional therapy [30, 31]. As the exoskeleton device also has these features [28], thus, we hypothesized that exoskeleton-based rehabilitation therapy might also encourage clinically relevant neuroplasticity with expected better clinical outcomes for distal joints in patients with stroke than the dose-matched conventional rehabilitation.
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