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Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial.

ABSTRACT: BACKGROUND:Balance impairments are common in patients with infratentorial stroke. Although robot-assisted gait training (RAGT) exerts positive effects on balance among patients with stroke, it remains unclear whether such training is superior to conventional physical therapy (CPT). Therefore, we aimed to investigate the effects of RAGT combined with CPT and compared them with the effects of CPT only on balance and lower extremity function among survivors of infratentorial stroke. METHODS:This study was a single-blinded, randomized controlled trial with a crossover design conducted at a single rehabilitation hospital. Patients (n?=?19; 16 men, three women; mean age: 47.4?±?11.6?years) with infratentorial stroke were randomly allocated to either group A (4?weeks of RAGT+CPT, followed by 4?weeks of CPT+CPT) or group B (4?weeks of CPT+CPT followed by 4?weeks of RAGT+CPT). Changes in dynamic and static balance as indicated by Berg Balance Scale scores were regarded as the primary outcome measure. Outcome measures were evaluated for each participant at baseline and after each 4-week intervention period. RESULTS:No significant differences in outcome-related variables were observed between group A and B at baseline. In addition, no significant time-by-group interactions were observed for any variables, indicating that intervention order had no effect on lower extremity function or balance. Significantly greater improvements in secondary functional outcomes such as lower extremity Fugl-Meyer assessment (FMA-LE) and scale for the assessment and rating of ataxia (SARA) were observed following the RAGT+CPT intervention than following the CPT+CPT intervention. CONCLUSION:RAGT produces clinically significant improvements in balance and lower extremity function in individuals with infratentorial stroke. Thus, RAGT may be useful for patients with balance impairments secondary to other pathologies. TRIAL REGISTRATION:ClinicalTrials.gov Identifier NCT02680691. Registered 09 February 2016; retrospectively registered.

SUBMITTER: Kim HY

PROVIDER: S-EPMC6664752 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial.

Kim Ha Yeon HY Shin Joon-Ho JH Yang Sung Phil SP Shin Min A MA Lee Stephanie Hyeyoung SH

Journal of neuroengineering and rehabilitation 20190729 1

<h4>Background</h4>Balance impairments are common in patients with infratentorial stroke. Although robot-assisted gait training (RAGT) exerts positive effects on balance among patients with stroke, it remains unclear whether such training is superior to conventional physical therapy (CPT). Therefore, we aimed to investigate the effects of RAGT combined with CPT and compared them with the effects of CPT only on balance and lower extremity function among survivors of infratentorial stroke.<h4>Meth ...[more]

PMID: 31358017

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Project description:This study investigated the effects of robot-assisted gait training (RAGT) on gait function in burn patients. Briefly, 40 burn patients were randomly divided into an RAGT group or a conventional training (CON) group. SUBAR® (Cretem, Korea) is a wearable robot with a footplate that simulates normal gait cycles. The RAGT group underwent 30 min of robot-assisted training using SUBAR® with 30 min of conventional physiotherapy once a day, 5 days a week for 12 weeks. Patients in the CON group received 30 min of overground gait training and range-of-motion (ROM) exercises twice a day for 5 days a week for 12 weeks. The RAGT group and the CON group underwent 60 min of training per day. The intervention frequency and duration did not differ between the RAGT group and the CON group. The main outcomes were functional ambulatory category (FAC); 6-min walking test (6MWT); visual analogue scale (VAS) during gait movement; ROM; and isometric forces of bilateral hip, knee, and ankle muscles before and after 12 weeks of training. The results of the VAS, FAC, and 6MWT (8.06 ± 0.66, 1.76 ± 0.56, and 204.41 ± 85.60) before training in the RAGT group improved significantly (4.41 ± 1.18, 4.18 ± 0.39, and 298.53 ± 47.75) after training (p < 0.001, p < 0.001, and p < 0.001). The results of the VAS, FAC, and 6MWT (8.00 ± 1.21, 1.75 ± 0.58, and 220.94 ± 116.88) before training in the CON group improved significantly (5.00 ± 1.03, 3.81 ± 1.05, and 272.19 ± 110.14) after training (p < 0.001, p < 0.001, and p = 0.05). There were differences in the improvement of results of the VAS, FAC, and 6MWT between groups after training, but they were not statistically significant (p = 0.23, p = 0.14, and p = 0.05). The isometric strengths of the right hip extensor (p = 0.02), bilateral knee flexor (p = 0.04 in the right, and p = 0.001 in the left), bilateral knee extensor (p = 0.003 in the right, and p = 0.002 in the left), bilateral ankle dorsiflexor (p = 0.04 in the right, and p = 0.02 in the left), and bilateral ankle plantarflexor (p = 0.001 in the right, and p = 0.008 in the left) after training were significantly improved compared with those before training in the RAGT group. The ROMs of the right knee extension (p = 0.03) and bilateral ankle plantarflexion (p = 0.008 in the right, and p = 0.03 in the left) were significantly improved compared with measurements before training in the RAGT. There were no significant differences of the isometric strengths and ROMs of the bilateral hip, knee, and ankle muscles after training in the CON group. There were significant improvements in the isometric strengths of the left knee flexor (p = 0.01), left ankle dorsiflexor (p = 0.01), and left ankle plantarflexor (p = 0.003) between the two groups. The results suggested that RAGT is effective to facilitate early recovery of muscles strength after a burn injury. This is the first study to evaluate the effectiveness of RAGT in patients with burns compared with those receiving conventional training. The absence of complications in burn patients provides an opportunity to enlarge the application area of RAGT.

Project description:Background: The limitation to the use of ElectroMyoGraphy (sEMG) in rehabilitation services is in contrast with its potential diagnostic capacity for rational planning and monitoring of the rehabilitation treatments, especially the overground Robot-Assisted Gait Training (o-RAGT). Objective: To assess the barriers to the implementation of a sEMG-based assessment protocol in a clinical context for evaluating the effects of o-RAGT in subacute stroke patients. Methods: An observational study was conducted in a rehabilitation hospital. The primary outcome was the success rate of the implementation of the sEMG-based assessment. The number of dropouts and the motivations have been registered. A detailed report on difficulties in implementing the sEMG protocol has been edited for each patient. The educational level and the working status of the staff have been registered. Each member of staff completed a brief survey indicating their level of knowledge of sEMG, using a five-point Likert scale. Results: The sEMG protocol was carried out by a multidisciplinary team composed of Physical Therapists (PTs) and Biomedical Engineers (BEs). Indeed, the educational level and the expertise of the members of staff influenced the fulfillment of the implementation of the study. The PTs involved in the study did not receive any formal education on sEMG during their course of study. The low success rate (22.7%) of the protocol was caused by several factors which could be grouped in: patient-related barriers; cultural barriers; technical barriers; and administrative barriers. Conclusions: Since a series of barriers limited the use of sEMG in the clinical rehabilitative environment, concrete actions are needed for disseminating sEMG in rehabilitation services. The sEMG assessment should be included in health systems regulations and specific education should be part of the rehabilitation professionals' curriculum. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03395717.

Project description:BACKGROUND:Robot-assisted ankle-foot-orthosis (AFO) can provide immediate powered ankle assistance in post-stroke gait training. Our research team has developed a novel lightweight portable robot-assisted AFO which is capable of detecting walking intentions using sensor feedback of wearer's gait pattern. This study aims to investigate the therapeutic effects of robot-assisted gait training with ankle dorsiflexion assistance. METHODS:This was a double-blinded randomized controlled trial. Nineteen chronic stroke patients with motor impairment at ankle participated in 20-session robot-assisted gait training for about five weeks, with 30-min over-ground walking and stair ambulation practices. Robot-assisted AFO either provided active powered ankle assistance during swing phase in Robotic Group (n?=?9), or torque impedance at ankle joint as passive AFO in Sham Group (n?=?10). Functional assessments were performed before and after the 20-session gait training with 3-month Follow-up. Primary outcome measure was gait independency assessed by Functional Ambulatory Category (FAC). Secondary outcome measures were clinical scores including Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), Berg Balance Scale (BBS), Timed 10-Meter Walk Test (10MWT), Six-minute Walk Test (SMWT), supplemented by gait analysis. All outcome measures were performed in unassisted gait after patients had taken off the robot-assisted AFO. Repeated-measures analysis of covariance was conducted to test the group differences referenced to clinical scores before training. RESULTS:After 20-session robot-assisted gait training with ankle dorsiflexion assistance, the active ankle assistance in Robotic Group induced changes in gait pattern with improved gait independency (all patients FAC???5 post-training and 3-month follow-up), motor recovery, walking speed, and greater confidence in affected side loading response (vertical ground reaction force +?1.49 N/kg, peak braking force +?0.24 N/kg) with heel strike instead of flat foot touch-down at initial contact (foot tilting +?1.91°). Sham Group reported reduction in affected leg range of motion (ankle dorsiflexion -?2.36° and knee flexion -?8.48°) during swing. CONCLUSIONS:Robot-assisted gait training with ankle dorsiflexion assistance could improve gait independency and help stroke patients developing confidence in weight acceptance, but future development of robot-assisted AFO should consider more lightweight and custom-fit design. TRIAL REGISTRATION:ClinicalTrials.gov NCT02471248 . Registered 15 June 2015 retrospectively registered.

Project description:Proprioception has a crucial role in promoting or hindering motor learning. In particular, an intact position sense strongly correlates with the chances of recovery after stroke. A great majority of neurological patients present both motor dysfunctions and impairments in kinesthesia, but traditional robot and virtual reality training techniques focus either in recovering motor functions or in assessing proprioceptive deficits. An open challenge is to implement effective and reliable tests and training protocols for proprioception that go beyond the mere position sense evaluation and exploit the intrinsic bidirectionality of the kinesthetic sense, which refers to both sense of position and sense of movement. Modulated haptic interaction has a leading role in promoting sensorimotor integration, and it is a natural way to enhance volitional effort. Therefore, we designed a preliminary clinical study to test a new proprioception-based motor training technique for augmenting kinesthetic awareness via haptic feedback. The feedback was provided by a robotic manipulandum and the test involved seven chronic hemiparetic subjects over 3?weeks. The protocol included evaluation sessions that consisted of a psychometric estimate of the subject's kinesthetic sensation, and training sessions, in which the subject executed planar reaching movements in the absence of vision and under a minimally assistive haptic guidance made by sequences of graded force pulses. The bidirectional haptic interaction between the subject and the robot was optimally adapted to each participant in order to achieve a uniform task difficulty over the workspace. All the subjects consistently improved in the perceptual scores as a consequence of training. Moreover, they could minimize the level of haptic guidance in time. Results suggest that the proposed method is effective in enhancing kinesthetic acuity, but the level of impairment may affect the ability of subjects to retain their improvement in time.

Project description:Background and Objectives: Gait disorders represent one of the most disabling aspects in multiple sclerosis (MS) that strongly influence patient quality of life. The improvement of walking ability is a primary goal for rehabilitation treatment. The aim of this study is to evaluate the effectiveness of robot-assisted gait training (RAGT) in association with physiotherapy treatment in patients affected by MS in comparison with ground conventional gait training. Study design: Randomized controlled crossover trial. Materials and Methods: Twenty-seven participants affected by MS with EDSS scores between 3.5 and 7 were enrolled, of whom seventeen completed the study. They received five training sessions per week over five weeks of conventional gait training with (experimental group) or without (control group) the inclusion of RAGT. The patients were prospectively evaluated before and after the first treatment session and, after the crossover phase, before and after the second treatment session. The evaluation was based on the 25-foot walk test (25FW, main outcome), 6 min walk test (6MWT), Tinetti Test, Modified Ashworth Scale, and modified Motricity Index for lower limbs. We also measured disability parameters using Functional Independence Measure and Quality of Life Index, and instrumental kinematic and gait parameters: knee extensor strength, double-time support, step length ratio; 17 patients reached the final evaluation. Results: Both groups significantly improved on gait parameters, motor abilities, and autonomy recovery in daily living activities with generally better results of RAGT over control treatment. In particular, the RAGT group improved more than control group in the 25FW (p = 0.004) and the 6MWT (p = 0.022). Conclusions: RAGT is a valid treatment option that in association with physiotherapy could induce positive effects in MS-correlated gait disorders. Our results showed greater effectiveness in recovering gait speed and resistance than conventional gait training.

Project description:Introduction:Gait exercise assist robot (GEAR), a gait rehabilitation robot developed for poststroke gait disorder, has been shown to improve walking speed and to improve the poststroke gait pattern. However, the persistence of its beneficial effect has not been clarified. In this matched case-control study, we assessed the durability of the effectiveness of GEAR training in patients with subacute stroke on the basis of clinical evaluation and three-dimensional (3D) gait analysis. Methods:Gait data of 10 patients who underwent GEAR intervention program and 10 patients matched for age, height, sex, affected side, type of stroke, and initial gait ability who underwent conventional therapy were extracted from database. The outcome measures were walk score of Functional Independence Measure (FIM-walk), Stroke Impairment Assessment Set total lower limb motor function score (SIAS-L/E), and 3D gait analysis data (spatiotemporal factors and abnormal gait patter indices) at three time points: baseline, at the end of intervention, and within 1 week before discharge. Results:In the GEAR group, the FIM-walk score, SIAS-L/E score, cadence, and single stance time of paretic side at discharge were significantly higher than those at post-training (p < 0.05), whereas the stance time and double support time of the unaffected side, knee extensor thrust, insufficient knee flexion, and external rotated hip of the affected side were significantly lower (p < 005). However, no significant differences in these respects were observed in the control group between the corresponding evaluation time points. Conclusion:The results indicated significant improvement in the GEAR group after the training period, with respect to both clinical parameters and the gait pattern indices. This improvement was not evident in the control group after the training period. The results possibly support the effectiveness of GEAR training in conferring persistently efficient gait patterns in patients with poststroke gait disorder. Further studies should investigate the long-term effects of GEAR training in a larger sample.

Dataset Information

Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial.

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Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial.

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