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Efficacy of a Novel Exoskeletal Robot for Locomotor Rehabilitation in Stroke Patients: A Multi-center, Non-inferiority, Randomized Controlled Trial.

ABSTRACT: Objective: To investigate the efficacy and safety of a novel lower-limb exoskeletal robot, BEAR-H1 (Shenzhen Milebot Robot Technology), in the locomotor function of subacute stroke patients. Methods: The present study was approved by the ethical committee of the First Affiliated Hospital of Nanjing Medical University (No. 2019-MD-43), and registration was recorded on the Chinese Clinical Trial Registry with a unique identifier: ChiCTR2100044475. A total of 130 patients within 6 months of stroke were randomly divided into two groups: the robot group and the control group. The control group received routine training for walking, while in the robot group, BEAR-H1 lower-limb exoskeletal robot was used for locomotor training. Both groups received two sessions daily, 5 days a week for 4 weeks consecutively. Each session lasted 30 min. Before treatment, after treatment for 2 weeks, and 4 weeks, the patients were assessed based on the 6-minute walking test (6MWT), functional ambulation scale (FAC), Fugl-Meyer assessment lower-limb subscale (FMA-LE), and Vicon gait analysis. Results: After a 4-week intervention, the results of 6MWT, FMA-LE, FAC, cadence, and gait cycle in the two groups significantly improved (P < 0.05), but there was no significant difference between the two groups (P > 0.05). The ratio of stance phase to that of swing phase, swing phase symmetry ratio (SPSR), and step length symmetry ratio (SLSR) was not significantly improved after 4 weeks of training in both the groups. Further analyses revealed that the robot group exhibited potential benefits, as the point estimates of 6MWT and Δ6MWT (post-pre) at 4 weeks were higher than those in the control group. Additionally, within-group comparison showed that patients in the robot group had a significant improvement in 6MWT earlier than their counterparts in the control group. Conclusions: The rehabilitation robot in this study could improve the locomotor function of stroke patients; however, its effect was no better than conventional locomotor training.

SUBMITTER: Li Y

PROVIDER: S-EPMC8419710 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionThe purpose of this study is to determine the effect of overground gait training using an exoskeletal wearable robot (exoskeleton) on the recovery of ambulatory function in patients with subacute stroke. We also investigate the assistive effects of an exoskeleton on ambulatory function in patients with subacute stroke.Methods and analysisThis study is an international, multicentre, randomised controlled study at five institutions with a total of 150 patients with subacute stroke. Participants will be randomised into two groups (75 patients in the robot-assisted gait training (RAGT) group and 75 patients in the control group). The gait training will be performed with a total of 20 sessions (60 min/session); 5 sessions a week for 4 weeks. The RAGT group will receive 30 min of gait training using an exoskeleton (ANGEL LEGS M20, Angel Robotics) and 30 min of conventional gait training, while the control group will receive 60 min conventional gait training. In all the patients, the functional assessments such as ambulation, motor and balance will be evaluated before and after the intervention. Follow-up monitoring will be performed to verify whether the patient can walk without physical assistance for 3 months. The primary outcome is the improvement of the Functional Ambulatory Category after the gait training. The functional assessments will also be evaluated immediately after the last training session in the RAGT group to assess the assistive effects of an exoskeletal wearable robot. This trial will provide evidence on the effects of an exoskeleton to improve and assist ambulatory function in patients with subacute stroke.Ethics and disseminationThis protocol has been approved by the Institutional Review Board of each hospital and conforms to the Declaration of Helsinki. The results will be disseminated through publication.Trial registration numberProtocol was registered at ClinicalTrials.gov (NCT05157347) on 15 December 2021 and CRIS (KCT0006815) on 19 November 2021.

Project description:BackgroundIn recent years, many studies focused on the use of robotic devices for both the assessment and the neuro-motor reeducation of upper limb in subjects after stroke, spinal cord injuries or affected by neurological disorders. Contrarily, it is still hard to find examples of robot-aided assessment and rehabilitation after traumatic injuries in the orthopedic field. However, those benefits related to the use of robotic devices are expected also in orthopedic functional reeducation.MethodsAfter a wrist injury occurred at their workplace, wrist functionality of twenty-three subjects was evaluated through a robot-based assessment and clinical measures (Patient Rated Wrist Evaluation, Jebsen-Taylor and Jamar Test), before and after a 3-week long rehabilitative treatment. Subjects were randomized in two groups: while the control group (n = 13) underwent a traditional rehabilitative protocol, the experimental group (n = 10) was treated replacing traditional exercises with robot-aided ones.ResultsFunctionality, assessed through the function subscale of PRWE scale, improved in both groups (experimental p = 0.016; control p < 0.001) and was comparable between groups, both pre (U = 45.5, p = 0.355) and post (U = 47, p = 0.597) treatment. Additionally, even though groups' performance during the robotic assessment was comparable before the treatment (U = 36, p = 0.077), after rehabilitation the experimental group presented better results than the control one (U = 26, p = 0.015).ConclusionsThis work can be considered a starting point for introducing the use of robotic devices in the orthopedic field. The robot-aided rehabilitative treatment was effective and comparable to the traditional one. Preserving efficacy and safety conditions, a systematic use of these devices could lead to decrease human therapists' effort, increase repeatability and accuracy of assessments, and promote subject's engagement and voluntary participation. Trial Registration ClinicalTrial.gov ID: NCT04739644. Registered on February 4, 2021-Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/study/NCT04739644 .

Project description:Purpose: Robot-assisted training has been widely used in neurorehabilitation, but its effect on facilitating recovery after stroke remains controversial. One possible reason might be lacking consideration of the role of embodiment in robotic systems. Mirror visual feedback is an ideal method to approach embodiment. Thus, we hypothesized that mirror visual feedback priming with subsequent robot-assisted training might provide additional treatment benefits in rehabilitation. Method: This is a prospective, assessor-blinded, randomized, controlled study. Forty subacute stroke patients were randomly assigned into an experimental group (N = 20) or a control group (N = 20). They received either mirror visual feedback or sham-mirror visual feedback prior to robot-assisted training for 1.5 h/day, 5 days/week for 4 weeks. Before and after intervention, the Fugl-Meyer Assessment Upper Limb subscale, the Functional Independence Measure, the modified Barthel Index, and grip strength were measured. Scores of four specified games were recorded pre and post one-time mirror visual feedback priming before intervention in the experimental group. Results: All measurements improved significantly in both groups following interventions. Moreover, the Fugl-Meyer Assessment Upper Limb subscale, self-care subscale of the Functional Independence Measure, and the grip strength were improved significantly in the experimental group after a 4-week intervention, compared with the control group. Significantly higher scores of two games were revealed after one-time priming. Conclusions: Mirror visual feedback prior to robot-assisted training could prompt motor recovery, increase ability of self-care, and potentially enhance grip strength in stroke patients, compared to control treatment. Moreover, mirror visual feedback priming might have the capability to improve the patient's performance and engagement during robot-assisted training, which could prompt the design and development of robotic systems. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: ChiCTR1900023356.

Project description:BackgroundRobotic rehabilitation after stroke provides the potential to increase and carefully control dosage of therapy. Only a small number of studies, however, have examined robotic therapy in the first few weeks post-stroke. In this study we designed robotic upper extremity therapy tasks for the bilateral Kinarm Exoskeleton Lab and piloted them in individuals with subacute stroke. Pilot testing was focused mainly on the feasibility of implementing these new tasks, although we recorded a number of standardized outcome measures before and after training.MethodsOur team developed 9 robotic therapy tasks to incorporate feedback, intensity, challenge, and subject engagement as well as addressing both unimanual and bimanual arm activities. Subacute stroke participants were assigned to a robotic therapy (N?=?9) or control group (N?=?10) in a matched-group manner. The robotic therapy group completed 1-h of robotic therapy per day for 10 days in addition to standard therapy. The control group participated only in standard of care therapy. Clinical and robotic assessments were completed prior to and following the intervention. Clinical assessments included the Fugl-Meyer Assessment of Upper Extremity (FMA UE), Action Research Arm Test (ARAT) and Functional Independence Measure (FIM). Robotic assessments of upper limb sensorimotor function included a Visually Guided Reaching task and an Arm Position Matching task, among others. Paired sample t-tests were used to compare initial and final robotic therapy scores as well as pre- and post-clinical and robotic assessments.ResultsParticipants with subacute stroke (39.8 days post-stroke) completed the pilot study. Minimal adverse events occurred during the intervention and adding 1 h of robotic therapy was feasible. Clinical and robotic scores did not significantly differ between groups at baseline. Scores on the FMA UE, ARAT, FIM, and Visually Guided Reaching improved significantly in the robotic therapy group following completion of the robotic intervention. However, only FIM and Arm Position Match improved over the same time in the control group.ConclusionsThe Kinarm therapy tasks have the potential to improve outcomes in subacute stroke. Future studies are necessary to quantify the benefits of this robot-based therapy in a larger cohort.Trial registrationClinicalTrials.gov, NCT04201613, Registered 17 December 2019-Retrospectively Registered, https://clinicaltrials.gov/ct2/show/NCT04201613 .

Project description:BACKGROUND:Recovery following a stroke is a long and ongoing process. Post-stroke follow-up after leaving the hospital is recommended. Methods for follow-up patients include face-to-face, via the telephone, post or online (internet). However, there is a debate which method is preferred by patients. This study aimed to determine whether telephone interview, online questionnaire and postal questionnaire were as acceptable as face-to-face follow-up. METHODS:In a blinded, UK-wide, multi-centre, Zelen's designed, 4-arm (postal, online, telephone, compared to face-to-face), pragmatic non-inferiority randomised controlled trial of the mode of administration, stroke survivors were randomised to postal, online, telephone and face-to-face assessment, in an equal ratio (1:1:1:1). The primary outcome was the proportion of participants that responded to the three allocation groups, compared to the face-to-face group. Subgroup analyses for age, aphasia and type and severity of stroke were carried out. A non-inferiority margin of 0.025 was used, and Holm-Bonferroni multiplicity adjustment was made. RESULTS:Of the 2074 eligible patients randomised, 55% were male (1142/2074), with an average age of 73.0 years old (SD = 13.2). Of those randomised, 22% (116/525), 9% (47/515) and 20% (101/513) responded in postal, online and telephone, respectively, compared to 17% (89/521) in the face-to-face group. The reduction in the online response rate compared to face-to-face was found to be both inferior and not non-inferior and estimated as an 8% reduction (95% CI 3.9 to 12.0%; p < 0.001). The association with lower online completion was present regardless of age, stroke type (haemorrhage or infarct) and stroke severity. In haemorrhagic stroke, the reduction in response online, compared to face-to-face, was 21% (95% CI 10 to 32%; p value = 0.002). A secondary analysis found non-aphasic stroke survivors preferred postal completion adjusted odds ratio of 1.43 (95% CI 1.04 to 1.95; p = 0.026). CONCLUSIONS:The study found that fewer stroke survivors completed follow-up assessment using an online method, compared to face-to-face. This finding was present in all age groups. Caution should be employed when considering online follow-up methods in stroke survivors, particularly in those who have experienced a cerebrovascular haemorrhage. TRIALS REGISTRATION:ClinicalTrials.gov, NCT03177161 . Registered on 6 June 2017.

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Efficacy of a Novel Exoskeletal Robot for Locomotor Rehabilitation in Stroke Patients: A Multi-center, Non-inferiority, Randomized Controlled Trial.

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