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单关节混合辅助肢体(HAL-SJ)机器人外骨骼疗法改善腕部骨折工人的功能结局:一项随机对照试验的研究方案

Single Joint Hybrid Assistive Limb (HAL-SJ) robotic exoskeleton therapy in improving functional outcomes among workers with wrist fractures: Study protocol for a randomized controlled trial.

作者信息

Tan Eng Wah, Chai Siaw Chui, Sankai Yoshiyuki, Shingu Masahiro, Razaob Nor Afifi, Hussain Hafez

机构信息

Occupational Therapy Programme, Centre for Rehabilitation & Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.

PERKESO Rehabilitation Centre, Melaka, Malaysia.

出版信息

PLoS One. 2025 Apr 24;20(4):e0322191. doi: 10.1371/journal.pone.0322191. eCollection 2025.

Abstract

INTRODUCTION

Robotic technologies have been developed for motor rehabilitation and such robots have shown favourable results when compared with equivalent doses of usual clinical therapy. Recently, robotic interventions have been suggested to be applied in orthopaedic rehabilitation with upper extremity disorders, especially those related to hand and wrist. This study aims to determine the effectiveness of combined conventional therapy and HAL-SJ robotic therapy in restoring the wrist functionality following the fractures as compared to the standard conventional therapy solely.

METHODS AND ANALYSIS

Workers with wrist fractures will be randomized in two groups, i.e., the control group (conventional therapy) and intervention group (combination of conventional therapy and robotic HAL-SJ intervention). All participants will receive 5-day/week therapy sessions for four weeks. Primary outcomes of the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure and secondary outcomes of range of motion, grip and pinch strengths, fine and gross hand dexterity as well as pain and the Lam Assessment of Stages of Employment Readiness (LASER) will be assessed at baseline assessment and upon completion of the therapy program after 4 weeks. Data from the baseline and post intervention outcome measures will be analysed using a Repeated Measures ANOVA to compare the therapy effectiveness of both control and intervention groups.

RESULTS

Participants recruitment and data collection are in progress.

DISCUSSION

Wrist fractures can produce some residual disability and pain that may impact the functionality of a person. The application of robotic technology in facilitating upper limb movement and functional recovery training is extensive and shows positive outcomes in the field of neurorehabilitation. However, there is a lacking of published evidence about the effectiveness of robotic intervention in orthopaedic rehabilitation, especially in the field of hand therapy.

CONCLUSION

Participants recruitment and data collection are still ongoing.

CLINICAL TRIAL REGISTRATION

This trial is registered with the Australian New Zealand Clinical Trials Registry (registration number: ACTRN12622000413729).

摘要

引言

已开发出用于运动康复的机器人技术,与同等剂量的常规临床治疗相比,此类机器人已显示出良好的效果。最近,有人建议将机器人干预应用于上肢疾病的骨科康复,尤其是与手和腕部相关的疾病。本研究旨在确定与单纯标准常规治疗相比,联合传统治疗和HAL-SJ机器人治疗在骨折后恢复腕部功能方面的有效性。

方法与分析

腕部骨折的工人将被随机分为两组,即对照组(传统治疗)和干预组(传统治疗与机器人HAL-SJ干预相结合)。所有参与者将接受为期四周、每周五天的治疗课程。在基线评估时以及治疗计划完成四周后,将评估手臂、肩部和手部功能障碍(DASH)结果测量的主要结果以及运动范围、握力和捏力、手部精细和粗大灵活性以及疼痛的次要结果,以及就业准备阶段的拉姆评估(LASER)。将使用重复测量方差分析对基线和干预后结果测量的数据进行分析,以比较对照组和干预组的治疗效果。

结果

参与者招募和数据收集正在进行中。

讨论

腕部骨折可能会产生一些残留残疾和疼痛,这可能会影响人的功能。机器人技术在促进上肢运动和功能恢复训练方面的应用广泛,并且在神经康复领域显示出积极的结果。然而,关于机器人干预在骨科康复中的有效性,尤其是在手部治疗领域,缺乏已发表的证据。

结论

参与者招募和数据收集仍在进行中。

临床试验注册

本试验已在澳大利亚新西兰临床试验注册中心注册(注册号:ACTRN12622000413729)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ddb/12021254/613947e22f96/pone.0322191.g001.jpg

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