Treatment with robot-assisted gait trainer Walkbot along with physiotherapy vs. isolated physiotherapy in children and adolescents with cerebral palsy. Experimental study.

BACKGROUND: Improving walking ability is a key objective in the treatment of children and adolescents with cerebral palsy, since it directly affects their activity and participation. In recent years, robotic technology has been implemented in gait treatment, which allows training of longer duration and repetition of the movement. To know the effectiveness of a treatment with the robotic-assisted gait trainer Walkbot combined with physiotherapy compared to the isolated physiotherapy treatment in children and adolescents with cerebral palsy, we carried out a clinical trial. METHODS: 23 participants, were divided into two groups: experimental and control. During 5 weeks, both groups received their physiotherapy sessions scheduled, in addition experimental group received 4 sessions per week of 40 min of robot. An evaluation of the participants was carried out before the intervention, at the end of the intervention, and at follow-up (two months after the end of the intervention). Gait was assessed with the Gross Motor Function Measure-88 dimensions D and E, strength was measured with a hydraulic dynamometer, and range of motion was assessed using the goniometer. A mixed ANOVA was performed when the assumptions of normality and homoscedasticity were met, and a robust mixed ANOVA was performed when these assumptions were not met. Statistical significance was stipulated at p < 0.05. For the effect size, η2 was calculated. RESULTS: Significant differences were found regarding the time x group interaction in the Gross Motor Function Measure-88 in dimension D [η2 = 0.016], in the flexion strength of the left [η2 = 0.128] and right [η2 = 0.142] hips, in the extension strength of the right hip [η2 = 0.035], in the abduction strength of the left hip [η2 = 0.179] and right [η2 = 0.196], in the flexion strength of the left knee [η2 = 0.222] and right [η2 = 0.147], and in the range of motion of left [η2 = 0.071] and right [η2 = 0.053] knee flexion. CONCLUSIONS: Compared to treatments without walking robot, physiotherapy treatment including Walkbot improves standing, muscle strength, and knee range of motion in children and adolescents with cerebral palsy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04329793. First posted: April 1, 2020.

Potential adverse effects of face mask use on cardiopulmonary function and thermoregulation in robotic stroke rehabilitation during the COVID-19 pandemic.

BACKGROUND: The coronavirus disease (COVID-19) pandemic led to the implementation of wearing face masks and social distancing in stroke rehabilitation to prevent airborne transmission and contain the virus. The use of masks causes hypoxia and dyspnea in patients with stroke, predisposing them to other harmful medical conditions. Despite the clinical importance of the potential risk of wearing masks during robotic stroke rehabilitation, no clinical evidence is available in the literature. OBJECTIVE: To examine the effects of stroke robotic rehabilitation with and without using a face mask on cardiopulmonary fatigue, muscle fatigue, O2 saturation, pulse, blood pressure (BP), and temperature in healthy adults and patients with hemiparetic stroke. METHOD: A total of 30 participants, comprising 20 males and 10 females, were enrolled in a case-control study and a cross-sectional randomized controlled trial conducted at the Center for Rehabilitation Hospital. The study population included 15 individuals with hemiparetic stroke (mean age: 57.26±8.69) and 15 healthy adult controls (mean age: 30.20±9.86). All participants underwent a 30-minute familiarization session, followed by experimental masked and unmasked robotic interactive gait training (RIGT) for at least 30 minutes. Clinical tests included the Borg Rating of Perceived Exertion, muscle fatigue via surface electromyography, O2 saturation, pulse, BP, and temperature. RESULTS: An analysis of covariance showed that compared to RIGT without a mask, RIGT with a mask showed adverse effects on BRPE, O2 saturation, and right rectus femoris muscle fatigue (P < 0.05) in the control and experimental groups. CONCLUSION: The clinical study revealed that compared to RIGT without a mask, RIGT with a mask affected cardiopulmonary fatigue, muscle fatigue, O2 saturation, pulse, and BP in healthy adults and participants with hemiparetic stroke.

Optimal Intervention Timing for Robotic-Assisted Gait Training in Hemiplegic Stroke.

This study was designed to determine the best intervention time (acute, subacute, and chronic stages) for Walkbot robot-assisted gait training (RAGT) rehabilitation to improve clinical outcomes, including sensorimotor function, balance, cognition, and activities of daily living, in hemiparetic stroke patients. Thirty-six stroke survivors (acute stage group (ASG), n = 11; subacute stage group (SSG), n = 15; chronic stage group (CSG), n = 10) consistently received Walkbot RAGT for 30 min/session, thrice a week, for 4 weeks. Six clinical outcome variables, including the Fugl-Meyer Assessment (FMA), Berg Balance Scale (BBS), Trunk Impairment Scale (TIS), Modified Barthel Index (MBI), Modified Ashworth Scale (MAS), and Mini-Mental State Examination, were examined before and after the intervention. Significant differences in the FMA, BBS, TIS, and MBI were observed between the ASG and the SSG or CSG. A significant time effect was observed for all variables, except for the MAS, in the ASG and SSG, whereas significant time effects were noted for the FMA, BBS, and TIS in the CSG. Overall, Walkbot RAGT was more favorable for acute stroke patients than for those with subacute or chronic stroke. This provides the first clinical evidence for the optimal intervention timing for RAGT in stroke.

Effects of Robotic Interactive Gait Training Combined with Virtual Reality and Augmented Reality on Balance, Gross Motor Function, Gait Kinetic, and Kinematic Characteristics in Angelman Syndrome: A Case Report.

Angelman syndrome (AS) is a genetic neurological disorder resulting in cognitive and neuromuscular impairments, such as lack of safety awareness and attention, as well as lack of balance and locomotor control. The robotic interactive gait training (RIGT) system is designed to provide accurate proprioceptive, kinematic, and kinetic feedback, and facilitate virtual reality and augmented reality (VR-AR) interactive exercises during gait training. In the present case report, we examined the effect of an innovative hip-knee-ankle interlimb-coordinated RIGT system. We utilized this therapeutic modality in a participant with Angelman syndrome (AS). Gross motor function measures, risk of fall, and gait-related kinetic (force), and kinematic (joint angle) biomechanical characteristics were assessed before and after 20 sessions of RIGT with VR-AR. We found RIGT with VR-AT improved gait ability, as shown by Performance-Oriented Mobility Assessment score, gross motor function by Gross Motor Function Measure score, balance by Pediatric Balance Scale score, knee and hip joint kinetics, and kinematics during gait. Our clinical and biomechanical evidence provide important clinical insights to improve the effectiveness of current neurorehabilitation approaches for treating patients with AS in balance and locomotor control and reduce the risk of falling.

Minimal Contact Robotic Stroke Rehabilitation on Risk of COVID-19, Work Efficiency and Sensorimotor Function.

Patients with hemiparetic stroke undergo direct, labor-intensive hands-on conventional physical therapy to improve sensorimotor function, spasticity, balance, trunk stability, and activities of daily living (ADLs). Currently, direct, intensive hands-on therapeutic modalities have increased concerns during the coronavirus (COVID-19) global pandemic. We developed an innovative Walkbot to mitigate the issues surrounding conventional hands-on physical therapy. We aimed to compare the effects of minimal-contact robotic rehabilitation (MRR) and full-contact conventional rehabilitation (FCR) on static and dynamic balance, trunk stability, ADLs, spasticity, and cognition changes in patients with hemiparetic stroke. A total of 64 patients with hemiparetic stroke (mean age = 66.38 ± 13.17; 27 women) underwent either MRR or FCR three times/week for 6 weeks. Clinical outcome measurements included the Trunk Impairment Scale (TIS), the Berg Balance Scale (BBS), the modified Ashworth Scale (MAS), the Fugl­Meyer Assessment (FMA), and the modified Barthel Index (MBI) scores. A 2 × 2 repeated analysis of variance (ANOVA) was performed, and an independent t-test was used to determine statistical differences in the physiotherapists' work efficiency and COVID-19 transmission risk. The ANOVA showed that MRR had effects superior to those of FCR on the TIS, the BBS, the FMA, and the MBI (p < 0.05), but not on the MAS (p = 0.230). MRR showed a greater decrease on the physiotherapist's work efficiency and COVID-19 transmission risk (p < 0.05). Our results provide clinical evidence that robot-assisted locomotor training helps maximize the recovery of sensorimotor function, abnormal synergy, balance, ADLs, and trunk stability, and facilitates a safer environment and less labor demand than conventional stroke rehabilitation.

Comparative effects of passive and active mode robot-assisted gait training on brain and muscular activities in sub-acute and chronic stroke.

BACKGROUND: Robot-assisted gait training (RAGT) was initially developed based on the passive controlled (PC) mode, where the target or ideal locomotor kinematic trajectory is predefined and a patient basically 'rides' the robot instead of actively participating in the actual locomotor relearning process. A new insightful contemporary neuroscience and mechatronic evidence suggest that robotic-based locomotor relearning can be best achieved through active interactive (AI) mode rather than PC mode. OBJECTIVE: The purpose of this study was to compare the pattern of gait-related cortical activity, specifically gait event-related spectral perturbations (ERSPs), and muscle activity from the tibialis anterior (TA) and clinical functional tests in subacute and chronic stroke patients during robot-assisted gait training (RAGT) in passive controlled (PC) and active interactive (AI) modes. METHODS: The present study involves a two-group pretest-posttest design in which two groups (i.e., PC-RAGT group and AI-RAGT group) of 14 stroke subjects were measured to assess changes in ERSPs, the muscle activation of TA, and the clinical functional tests, following 15- 18 sessions of intervention according to the protocol of each group. RESULTS: Our preliminary results demonstrated that the power in the µ band (8- 12 Hz) was increased in the leg area of sensorimotor cortex (SMC) and supplementary motor area (SMA) at post-intervention as compared to pre-intervention in both groups. Such cortical neuroplasticity change was associated with TA muscle activity during gait and functional independence in functional ambulation category (FAC) and motor coordination in Fugl- Meyer Assessment for lower extremity (FMA-LE) test as well as spasticity in the modified Ashworth scale (MAS) measures. CONCLUSIONS: We have first developed a novel neuroimaging experimental paradigm which distinguished gait event related cortical involvement between pre- and post-intervention with PC-RAGT and AI-RAGT in individuals with subacute and chronic hemiparetic stroke.

Stage 2: Who Are the Best Candidates for Robotic Gait Training Rehabilitation in Hemiparetic Stroke?

We aimed to compare the effects of robotic-assisted gait training (RAGT) in patients with FAC < 2 (low initial functional ambulation category [LFAC]) and FAC ≥ 2 (high initial functional ambulation category [HFAC]) on sensorimotor and spasticity, balance and trunk stability, the number of steps and walking distance in subacute hemiparetic stroke. Fifty-seven patients with subacute hemiparetic stroke (mean age, 63.86 ± 12.72 years; 23 women) were assigned to two groups. All patients received a 30-min Walkbot-assisted gait training session, 3 times/week, for 6 weeks. Clinical outcomes included scores obtained on the Fugl-Meyer Assessment (FMA) scale, Modified Ashworth Scale (MAS), Berg Balance Scale (BBS), trunk impairment scale (TIS), and the number of walking steps and walking distance. Analysis of covariance and analysis of variance were conducted at p < 0.05. Significant main effects of time in both groups on number of walking steps and distance (p < 0.05) were observed, but not in MAS (p> 0.05). Significant changes in FMA, BBS, and TIS scores between groups (p < 0.05) were observed. Significant main effects of time on BBS and TIS were demonstrated (p < 0.05). Our study shows that RAGT can maximize improvement in the functional score of FMA, BBS, TIS, steps, and distance during neurorehabilitation of subacute stroke patients regardless of their FAC level.

Effects of innovative hip-knee-ankle interlimb coordinated robot training on ambulation, cardiopulmonary function, depression, and fall confidence in acute hemiplegia.

BACKGROUND: While Walkbot-assisted locomotor training (WLT) provided ample evidence on balance and gait improvements, the therapeutic effects on cardiopulmonary and psychological elements as well as fall confidence are unknown in stroke survivors. OBJECTIVE: The present study aimed to compare the effects of Walkbot locomotor training (WLT) with conventional locomotor training (CLT) on balance and gait, cardiopulmonary and psychological functions and fall confidence in acute hemiparetic stroke. METHODS: Fourteen patients with acute hemiparetic stroke were randomized into either the WLT (60 min physical therapy + 30 min Walkbot-assisted gait training) or CLT (60 min physical therapy + 30 min gait training) groups, 7 days/week over 2 weeks. Clinical outcomes included the Berg Balance Scale (BBS), Functional Ambulation Category (FAC), heart rate (HR), Borg Rating of Perceived Exertion (BRPE), Beck Depression Inventory-II (BDI-II), and the activities-specific balance confidence (ABC) scale. The analysis of covariance (ANCOVA) was conducted at P < 0.05. RESULTS: ANCOVA showed that WLT showed superior effects, compared to CLT, on FAC, HR, BRPE, BDI-II, and ABC scale (P < 0.05), but not on BBS (P = 0.061). CONCLUSIONS: Our results provide novel, promising clinical evidence that WLT improved balance and gait function as well as cardiopulmonary and psychological functions, and fall confidence in acute stroke survivors who were unable to ambulate independently.

Effects of Walkbot gait training on kinematics, kinetics, and clinical gait function in paraplegia and quadriplegia.

BACKGROUND: The robotic-assisted gait training (RAGT) system has gained recognition as an innovative, effective paradigm to improve functional ambulation and activities of daily living in spinal cord injury and stroke. However, the effects of the Walkbot robotic-assisted gait training system with a specialized hip-knee-ankle actuator have never been examined in the paraplegia and quadriplegia population. OBJECTIVE: The aim of this study was to determine the long-term effects of Walkbot training on clinical for hips and knee stiffness in individuals with paraplegia or quadriplegia. METHODS: Nine adults with subacute or chronic paraplegia resulting from spinal cord injury or quadriplegia resulting from cerebral vascular accident (CVA) and/or hypoxia underwent progressive conventional gait retraining combined with the Walkbot RAGT for 5 days/week over an average of 43 sessions for 8 weeks. Clinical outcomes were measured with the Functional Ambulation Category (FAC), Modified Rankin Scale (MRS), Korean version of the Modified Barthel Index (K-MBI), Modified Ashworth Scale (MAS). Kinetic and kinematic data were collected via a built-in Walkbot program. RESULTS: Wilcoxon signed-rank tests showed significant positive intervention effects on K-MBI, maximal hip flexion and extension, maximal knee flexion, active torque in the knee joint, resistive torque, and stiffness in the hip joint (P <  0.05). These findings suggest that the Walkbot RAGT was effective for improving knee and hip kinematics and the active knee joint moment while decreasing hip resistive force. These improvements were associated with functional recovery in gait, balance, mobility and daily activities. CONCLUSIONS: These findings suggest that the Walkbot RAGT was effective for improving knee and hip kinematics and the active knee joint moment while decreasing hip resistive force. This is the first clinical evidence for intensive, long-term effects of the Walkbot RAGT on active or resistive moments and stiffness associated with spasticity and functional mobility in individuals with subacute or chronic paraplegia or quadriplegia who had reached a plateau in motor recovery after conventional therapy.