Robot-assisted gait training for improved gait independence in individuals with acute hemiparetic stroke: study protocol for a randomized controlled pilot trial.

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Daisuke Kato, Satoshi Hirano, Daisuke Imoto, Takuma Ii, Daisuke Matsuura, Takuma Ishihara, Yohei Otaka
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引用次数: 0

Abstract

Background: Robot-assisted gait training (RAGT) has proven effective in addressing gait disorders in patients with stroke. However, its efficacy in patients with acute stroke has not yet been demonstrated. This pilot study is designed to evaluate the following: (1) feasibility of conducting a randomized controlled trial on RAGT for enhancing gait postacute stroke and (2) to obtain preliminary estimates regarding the potential efficacy of RAGT for achieving gait independence during the acute phase.

Methods: We will conduct an assessor-blinded, single-center, randomized controlled pilot trial involving 32 patients with acute stroke who are unable to walk. Participants will be randomly assigned to either the RAGT or the conventional gait training (CGT) groups. Each participant will receive 180 min of daily rehabilitation, including 60 min dedicated to gait training. The RAGT group will receive 40 min of RAGT and 20 min of CGT, while the CGT group will engage in 60 min of CGT. Interventions will continue for up to 8 weeks, or until participants achieve gait independence, as indicated by a Functional Ambulation Category score of ≥ 3. Feasibility outcomes will include recruitment, enrollment, protocol adherence, and retention rates. The primary clinical outcome will be the incidence of achieving gait independence during the intervention period. Secondary clinical outcomes will include gait performance measures, assessments of physical function and activity, and intervention dose. Adverse events associated with RAGT and CGT will also be documented to evaluate the safety of both interventions.

Discussion: Implementing RAGT during the acute phase of stroke may facilitate earlier attainment of gait independence compared to CGT. We aim to provide valuable insights into the feasibility of the proposed study design and generate preliminary data on the potential effects of RAGT on gait independence in the acute phase of stroke, providing a framework for future larger-scale trials.

Trial registration: This clinical trial was registered with the Japan Clinical Trials Registry (jRCT) on 19 June 2023 (registration number: jRCTs042230040). The study protocol was initially registered as version 1.0 and has since undergone minor amendments-currently on version 4.0. This protocol was written based on the latest version (ver. 4.0) registered with jRCT.

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机器人辅助步态训练改善急性偏瘫性中风患者的步态独立性:随机对照试验的研究方案。
背景:机器人辅助步态训练(RAGT)已被证明对解决卒中患者的步态障碍有效。然而,其对急性脑卒中患者的疗效尚未得到证实。本试点研究旨在评估以下内容:(1)开展RAGT增强急性卒中后步态的随机对照试验的可行性;(2)初步评估RAGT在急性期实现步态独立的潜在功效。方法:我们将进行一项评估盲、单中心、随机对照的先导试验,纳入32例急性中风患者,这些患者不能行走。参与者将被随机分配到RAGT或常规步态训练(CGT)组。每位参与者每天将接受180分钟的康复训练,其中包括60分钟的步态训练。RAGT组接受40分钟的RAGT和20分钟的CGT,而CGT组进行60分钟的CGT。干预将持续长达8周,或直到参与者达到步态独立,如功能行走分类评分≥3所示。可行性结果将包括招募、注册、协议遵守和保留率。主要的临床结果将是在干预期间实现步态独立的发生率。次要临床结果将包括步态性能测量、身体功能和活动评估以及干预剂量。与RAGT和CGT相关的不良事件也将被记录下来,以评估这两种干预措施的安全性。讨论:与CGT相比,在中风急性期实施RAGT可能有助于更早地实现步态独立。我们的目标是为提出的研究设计的可行性提供有价值的见解,并产生关于RAGT对中风急性期步态独立的潜在影响的初步数据,为未来更大规模的试验提供框架。试验注册:该临床试验于2023年6月19日在日本临床试验注册中心(jRCT)注册(注册号:jRCTs042230040)。该研究方案最初注册为1.0版本,此后进行了少量修改,目前为4.0版本。该协议是基于最新版本(版本)编写的。4.0)在jRCT注册。
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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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