Stationary rehabilitation robot and functional electrostimulation for the treatment of patients in the initial six months after stroke: a randomized controlled trial
Stationary rehabilitation robot and functional electrostimulation for the treatment of patients in the initial six months after stroke: a randomized controlled trial

Summary/Abstract: Background: Results from studies investigating the effects of rehabilitation robots, including those using robots combined with functional electrostimulation (FES), on gait quality and postural control post-stroke are conflicting. Therefore, the evidence supporting the use of this approach to rehabilitation remains inconclusive and further research is required into how robotic therapy and FES can improve gait function and postural control at different times after stroke.Aim of the study: To gain knowledge on the effectiveness of stationary robotic exercises, and robotic exercises combined with FES of the lower extremity muscles, on activities of daily living, gait quality, postural control, and quality of life, in people who were between one and six months post-stroke.Material and methods: A randomized controlled clinical pilot study was conducted. Forty-three post-stroke patients hospitalized at a rehabilitation center were randomly assigned to the following three groups: the GEO Group, for whom stationary robotic exercises were provided, the GEO+FES Group, for whom stationary robotic exercises were provided in combination with FES, and the Control Group, for whom conventional overground gait training was provided. Exercises were undertaken by all groups for 20 minutes a day, six days a week, for three weeks. In addition, all patients were provided with basic post-stroke therapy based on the principles of best clinical practice. All patients were assessed for stroke symptoms before and after therapy using the National Institutes of Health Stroke Scale (NIHSS), for independence in activities of daily living using the Barthel Index, and for quality of life using the Stroke Impact Scale Questionnaire. Static and dynamic postural control and gait performance were assessed using the Berg Balance Scale, the Timed Up and Go Test, Medical Science Pulse 2022 (16) 4Stationary rehabilitation robot and functional electrostimulation for the treatment of patients... 33BackgroundStroke is a serious medical and social problem and, according to the World Health Organization, it is the second most common cause of death and the third most common cause of disability worldwide [1]. Post-stroke rehabilitation is multidirectional and long-lasting and is conducted in line with the principles of best clinical practice. Different types of therapies are implemented in stroke patients to enable neuromuscular re-education and restore functions that were lost or impaired as a result of stroke [2, 3]. New therapeutic methods are still being sought for post-stroke rehabilitation that aim to expand on the methods available and to be motivating and attractive to patients. Modern devices such as rehabilitation robots, which are used for gait re-education and postural control, are currently being introduced. Attempts are also being made to combine robotic exercises with functional electrical stimulation (FES) of the lower limb muscles. From this, it is thought that robots could provide a complete and reproducible gait pattern, which is difficult to achieve using conventional overground gait training [4].Both stationary and mobile robots are used in post-stroke rehabilitation. Stationary robots are mainly used to exercise patients with severe functional impairments of the lower limbs and spine. In contrast, people with paresis of the lower limbs can exercise on mobile robots, but they require the ability to at least partially stabilize their spine. Although robots have been used in rehabilitation for several years, there is still insufficient science-based knowledge regarding their effectiveness and application in post-stroke rehabilitation.Stationary robots have been evaluated in eleven randomized clinical trials [5-15] for their suitability to re-educate and improve postural control [6-8, 10] and gait [5-15] in stroke patients. The majority of these studies involved people who were between one and three months post-stroke [5, 7, 9-14], with only three studies focusing on the chronic (>6 months) post-stroke period [6, 8, 15]. In all of the cited studies, conventional therapy was used in both the experimental and control groups. Stationary robotic exercises were used in the experimental groups, and results were compared to those obtained for the control groups. The studies employed several different strategies for their control groups, including standard rehabilitation therapy that was not specifically directed at improving gait and postural control [8, 9, 13], traditional overground gait training [6, 7, 10-12, 14], and exercises on a treadmill [5, 15].In three of the trials, additional experimental groups were formed in which exercise on a stationary robot was combined with FES of the lower limb muscles. Results from therapy in these groups were compared with the results of robotic therapy without FES and with the results of overground gait training [6, 7, 10]. Two of these studies were conducted in people who were up to three months post-stroke [7, 10], and one study involved individuals in the chronic post-stroke period [6]. In all studies that followed patients for up to three months after stroke, stationary robot therapy significantly improved functional gait quality, which was assessed using the Functional Ambulation Categories (FAC) scale [5, 7, 9-14]. Four studies also reported significant improvements in walking during the 6-minute Walk Test (6MWT) [6, 11], and in the 10-Metre Walk Test (10MWT) [7, 10, 11], after exercise on a stationary robot. However, these effects were not found in two separate studies [5, 14]. Different results were also found when the effects of stationary robot exercise on static and dynamic body balance in patients three months post-stroke were assessed using the Berg Balance Scale (BBS) [7, 10]. Tong et al. [7] reported an improvement in body balance after exercise on the stationary robot, whereas Ng et al. [10] did not show this effect. For chronic post-stroke patients, only one study has reported an improvement in gait parameters, including speed, cadence, and stride length, assessed on a treadmill [15], and in body balance assessed by the BBS [15], after stationary robot therapy. In the the Functional Reach Test, and the 10 Meter Walk Test. Static postural control and gait quality were also assessed using a treadmill with a stabilometric platform. Results: Exercising on a stationary robot, both with and without FES of the lower extremity muscles, contributed to a statistically significant reduction in stroke symptoms (NIHSS, p<0.05). Additionally, exercising on a stationary robot without FES application significantly improved patient quality of life (p<0.05). However, these effects were not significantly different between the experimental and control groups. Conclusions: Stationary robotic exercise, either with or without FES, can be used as a substitute for traditional overground gait training to reduce stroke symptoms and improve quality of life in the first six months post-stroke. They can also be used as exercises to augment standard post-stroke therapy.

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