ALBA 装置评估成人亚急性和慢性获得性脑损伤上肢运动功能：智利大都市地区三级诊所的随机对照试验方案。

Evaluation of ALBA device for upper extremity motor function in adults with subacute and chronic acquired brain injury: a randomised controlled trial protocol in a tertiary clinic of the metropolitan region of Chile.

机构信息

uMov Startup, Concepción, Chile.

Rehabilitation Department, Los Coihues Clinic, Santiago, Chile.

出版信息

BMJ Open. 2023 Nov 22;13(11):e076774. doi: 10.1136/bmjopen-2023-076774.

DOI:10.1136/bmjopen-2023-076774

PMID:37993168

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10668162/

Abstract

INTRODUCTION

Stroke is a significant worldwide cause of death and a prevalent contributor to long-term disability among adults. Survivors commonly encounter a wide array of motor, sensory and cognitive impairments. Rehabilitation interventions, mainly targeting the upper extremities, include a wide array of components, although the evidence indicates that the intensity of practice and task-specific training play crucial roles in facilitating effective results. Assisted therapy with electronic devices designed for the affected upper extremity could be employed to enable partial or total control of this limb, while simultaneously incorporating the aforementioned characteristics in the rehabilitation process.

METHODS AND ANALYSIS

32 adults who had a subacute or chronic stroke, aged over 18 years old, will be included for this randomised controlled trial aiming to determine the non-inferiority effect of the inclusion of a robotic device (ALBA) to regular treatment against only regular rehabilitation. Participants will be assessed before and after 4 weeks of intervention and at 3 months of follow-up. The primary outcome will be the Fugl-Meyer assessment for upper extremities; secondary outcomes will include the questionnaires Functional Independence Measure, Medical Outcomes Study 36-item Short-Form Health Survey as well as the System Usability Scale.

ETHICS AND DISSEMINATION

Full ethical approval was obtained for this study from the scientific and ethical review board Servicio de Salud Metropolitano Oriente of Santiago (approval number: SSMOriente030522), and the recommendations of the Chilean law no 20120 of 7 September 2006, concerning scientific research in the human being, its genome and human cloning, will be followed. Ahead of inclusion, potential participants will read and sign a written informed consent form. Future findings will be presented and published in conferences and peer-reviewed journals.

TRIAL REGISTRATION NUMBER

International ClinicalTrials.gov Registry (NCT05824416; https://clinicaltrials.gov/ct2/show/NCT05824416?term=uMOV&draw=2&rank=1).

摘要

简介

脑卒中是全球范围内导致死亡的重要原因之一，也是成年人长期残疾的主要原因。幸存者通常会遇到各种运动、感觉和认知障碍。康复干预措施主要针对上肢，包括多种组成部分，尽管有证据表明，练习的强度和任务特异性训练在促进有效结果方面起着至关重要的作用。使用为受影响的上肢设计的电子设备进行辅助治疗，可以实现对该肢体的部分或完全控制，同时在康复过程中融入上述特征。

方法和分析

本随机对照试验将纳入 32 名年龄在 18 岁以上的亚急性或慢性脑卒中成年人，旨在确定包括机器人设备（ALBA）在内的干预措施与仅常规康复治疗相比的非劣效性效果。参与者将在干预前、干预后 4 周和 3 个月的随访时进行评估。主要结局将是上肢 Fugl-Meyer 评估；次要结局将包括功能独立性测量问卷、医疗结果研究 36 项简短健康调查以及系统可用性量表。

伦理和传播

本研究已获得圣地亚哥大都市卫生局科学和伦理审查委员会（批准号：SSMOriente030522）的全面伦理批准，并将遵循 2006 年 9 月 7 日关于人类、人类基因组和人类克隆的科学研究的智利法律 20120 的建议。在纳入之前，潜在参与者将阅读并签署书面知情同意书。未来的研究结果将在会议和同行评议期刊上进行展示和发表。