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국문

엑소워크는 국내제작 로봇으로 지면보행이 가능한 외골격형 로봇으로서 보행 훈련을 위하여 만들어 졌다. 그동안 메타분석을 통하여 로봇보행훈련의 효과는 급성기 혹은 아급성기 환자에 효과가 있다고 밝혀지고 있다. 본 연구에서는 뇌졸중 환자를 대상으로 엑소워크를 이용한 로봇보행치료를 하여 효과가 있는지 확인하고자 한다. 재활보행치료 효과는 근력, 균형, 보행속도와 능력을 통해서 밝히고자 한다.

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To evaluate the effectiveness of electromechanical-assisted gait training compared to conventional gait training on walking ability and symmetry in stroke patients. Patients with stroke (n = 144) were randomly assigned to control (physical therapist-assisted gait training) and experimental groups (electromechanical gait training). Both types of gait training were performed for 30 minutes each day, 5 days a week for 4 weeks. Main outcome measures are changes in functional ambulatory category (FAC).
<Safety considerations>
This clinical trial will be conducted scientifically and ethically in accordance with clinical trial management standards and clinical trial-related laws. In addition, this clinical trial will be conducted in accordance with the Declaration of Helsinki, respecting human dignity and rights and not causing any disadvantage to the subject.
<Data management and statistical analysis>
This research protocol has a potential risk that the possibility of exposing subjects' personal information in the process of collecting and registering medical records. To prevent this, both  name and resident registration number are processed as encrypted information, so no personal information is disclosed. 
For demographic and clinical characteristics, categorical variables are presented as frequency and percentage. They were analyzed for pre-homogeneity with Chi-squired tests. Continuous variables are presented as mean, standard deviation (SD), and range of minimum and maximum (Min, Max). In case of height and weight satisfying normality, pre-homogeneity was analyzed using student's t-test. For age not satisfying normality, Wilcoxon rank sum test was used. 
All values of primary and secondary outcomes are presented as mean and SD (Mean ± SD). Within each group, values of pre and post-intervention changes were analyzed using paired t-test if normality was satisfied or Wilcoxon's signed rank test if normality was not satisfied. In addition, for comparison between pre and post-intervention values of test and control groups, student's t-test and Wilcoxon's rank sum test were performed. 
Stroke duration was the most important factor that affected results. Subgroup analysis compared variations between subjects with stroke durations of 90 days or less (below 90 days) and those with 91 days or more (over 91 days) in the experimental group. 
The effectiveness analysis of this clinical trial is performed on FAS (Full Analysis Set). All statistical analyses were performed using SAS version 9.4 or later. All statistical tests were two-sided and the level of significance was set at 0.05.
<Quality assurance>
Principal investigators will hold a researcher meeting or clinical trial initiation meeting for this clinical trial before the start of the clinical trial. In this meeting, detailed discussions on the clinical trial protocol, the implementation of the clinical trial procedure, and the preparation of the CRF, data entry, coding, data archiving will be held. Investigators who cannot attend these meetings, or who will later participate in clinical trials, should receive appropriate training by the sponsor or person authorized by the principal investigator. 
-Monitoring
Designate a CRA in charge of this clinical trial to visit and monitor the laboratory before the start of the clinical trial and during the trial period.
CRA explains the monitoring plan to the investigator before starting the clinical trial, and discusses the visit schedule with the research team of the conducting institution before each monitoring visit.  In addition, during the monitoring visit, the CRA confirms that the investigator is conducting the clinical trial in accordance with the clinical trial protocol and related regulations.
Matters found during monitoring should be properly discussed with the investigator and resolved.
CRA will also be contacted and discussed with the investigator by means of communication such as telephone, fax, and e-mail.

국문

기존의 치료사에 의한 보행치료를 하는 군과 로봇에 의한 보행치료을 하는 군으로 나눈다. 두 군 모두 일일 30분, 주5회, 4주간 보행훈련 혹은 로봇치료를 한다. 연구자는 연구대상자가 속해 있는 군을 알 수 없으며 중재를 위한 치료사는 연구와 관련없는 제 3자로 배정한다.

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This study on the efficacy and safety of Electromechanical -assisted gait trainer EXOWALK ®(HR-01) is a multicenter, randomized and parallel-group study. All enrolled subjects are patients with stroke. Three clinical research centers in Korea participate in this trial: Dongguk University Ilsan Hospital, Chungnam National University Hospital and Seoul National University Bundang Hospital. Participating institutions in the study received clinical research approval as a research proposal delivered by the responsible institution to the Institutional Review Board (IRB) of each institution.When the research plan was changed, the changes and reasons were delivered to the research participating institution by e-mail, and a request for reconsideration was made to the IRB with the changed research proposal. Strategies for achieving adequate participant enrolment is to promote the hospital, such as posters that patients and visitors can see. Each subject provides informed consent before enrollment. The research director explains the contents of the consent form to the patient for 30 minutes using terms that are easy for the general public to understand. 
<Screening>
The screening is conducted based on data from patients who agreed in agreement, patients who met the inclusion and exclusion criteria, and hospitals. The target sample size is 144 subjects. 
This study is a multicenter, parallel-group and single blind trial. For this clinical trial, subjects who meet all of the subject inclusion/exclusion criteria and agree to participate in this study are assigned to two groups, an experimental group and a control group, according to a randomization table. Randomization is performed by an independent statistician using a random number generator computerized by the block randomization method in SAS version 9.4 (SAS institute Inc. Cary, NC, USA) or later. A separate randomization file is created for each research institute. Randomization plans may be viewed in case of emergency when the blind should be removed for any subject. In this case, we will describe the reasons why randomization should be released, the procedure, the documentation required, the series of treatments and the evaluation of the subject.
All patients in both groups are given 30 minutes (1 session) five times per week for four weeks. In addition, both groups perform basic rehabilitation (central nervous system development therapy and strength exercise) and the experimental group performed Electromechanical -assisted gait training with EXOWLK, and the control group performed conventional gait rehabilitation treatment. However, the presence or absence of existing rehabilitation treatments is different for outpatients. Therefore, if an outpatient was performing no existing rehabilitation treatment, proceed with the clinical test without existing rehabilitation and keep it in place if the existing rehabilitation treatment was being performed.

All patients in both groups undergo the existing rehabilitation treatment. The existing rehabilitation consists of Neurodevelopmental Treatment(NDT) and strength training. NDT is a rehabilitation treatment that induces the balance and control of sitting and standing postures by activating the reflex action of the paralyzed lower limb using the Bobath technique. Strength training is a mobility exercise to increase the range of motion of the paralyzed muscles and strength training to improve strength.
Electromechanical -assisted gait training 
As a treatment performed in the experimental group, the patients perform the Electromechanical -assisted gait training in addition to the existing rehabilitation treatment. The medical device is ‘EXOWALK®(HR-01), a rehabilitation robot for the lower limbs under clinical trials. 
As a treatment performed in the control group, the physiotherapist guides and walks the patient while assisting on the side or back of the subject.

상세내용 영문

Received electromechanical-assisted gait training with Exowalk® 
30 minutes a day, 5 days a week for 4 weeks 
As a treatment performed in the experimental group, the patients perform the Electromechanical -assisted gait training in addition to the existing rehabilitation treatment. The medical device is ‘EXOWALK®(HR-01), a rehabilitation robot for the lower limbs under clinical trials. 
Because patient’s tolerance and safety of electromechanical gait training compared to physiotherapy need to be considered, Exowalk® facilitates less than 1000 steps in 30 min with a velocity of 1.8 km/h according to initial evaluation, although its maximum velocity is 2.3 km/h. Patients in this study were recommended to receive the electromechanical exoskeleton-assisted gait training at a comfortable speed. 

상세내용 영문

Received conventional gait rehabilitation treatment by therapists. 
30 minutes a day, 5 days a week for 4 weeks  
For subjects in the control group, the physiotherapist guided and walked the patient while assisting the subject on the side or the back.

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Patients with Stroke. 

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Functional ambulatory category (FAC), FAC was determined the existence of independent walking through a concise level assessment. Primary endpoints were evaluated once at baseline (pre-intervention) four weeks after the baseline (post-intervention), and four weeks after the last treatment (follow-up). FAC was evaluated by dividing the degree of needing for assistance when walking to 1 to 6. FAC level ranged from Level 1 for ‘nonfunctional’ to Level 6 for ‘independent without help for non-level surfaces’. 

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before and after treatment, 4weeks follow up

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Second endpoints had a total of 7 assessments. First, RMI was used to evaluate motor skills. It consisted of 15 questions step by step, depending on the level ranging from bed rotation to running. A total of 15 questions were scored. Each was scored 1 point if yes or 0 if no. The total sum was used as a result of the evaluation. Second, walking velocity as a 10mWT was used to measure the speed during a 10-meter walking. The unit was m/sec (meter per second). Similarly, walking capacity was evaluated with a 6MWT to measure the distance that one could walk for 6 minutes. The unit was m (meter). The fourth item was MI. It was evaluated as 1 to 99 points by measuring the lower leg force level from the ankle to the knee. Assessment items consisted of three questions, each with a score of 0/9/14/19/25/33. The total sum of scores was used as the result of the evaluation. The fifth item was BBS to evaluate the balance ability with 0 to 56 points. There were 14 questions in total. Each question was scored from 0 to 4 points. The total sum of scores was used as the result of the evaluation. The last two evaluation items were measured with motion analysis devices for those who could walk stable without aids. Swing time asymmetry and step length asymmetry were analyzed by HumanTrack (Rbiotech, 1806A_DA004_H1FS, South Korea) a gait analysis system which is capable of performing walking analysis at a distance of 5-7 m without space restriction. The swing time was calculated based on phase of gait begins when the foot first leaves the ground and ends when the same foot touches the ground again. The step length was calculated as the distance between the heel of the foot and the heel of the other foot. Each asymmetry value was calculated as the absolute value difference between the paretic side and the non-paretic side. The physical content of the clinical alteration was reported by auditors, practitioners, and patients at each visit. All indication, data of onset, and period were r

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before and after treatment, 4weeks follow up

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FAC showed significant improvement after 4 weeks intervention in both groups. Walking abilities showed significant improvement after intervention, but, walking symmetries did not in both groups. According to sub-group analysis of stroke duration of 90 days, FAC and walking abilities in both groups showed significant improvement in subacute group compared to chronic group. However, walking symmetries did not show any significant changes in subacute and chronic group. Swing time asymmetry in the experimental group showed significant improvement in chronic group while it did not in the control group.