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单一机构研究使用可穿戴混合辅助肢体对出血性疾病患者进行康复治疗的效果:一项随机对照试验的研究方案。

Single-facility study of the effectiveness of rehabilitation therapy using wearable hybrid assistive limb for patients with bleeding disorders: study protocol for a randomised controlled trial.

机构信息

Medicinal Biology of Thrombosis and Haemostasis, Nara Medical University, Kashihara, Nara, Japan.

Department of Rehabilitation Medicine, Nara Medical University, Kashihara, Nara, Japan.

出版信息

BMJ Open. 2023 Nov 19;13(11):e076153. doi: 10.1136/bmjopen-2023-076153.


DOI:10.1136/bmjopen-2023-076153
PMID:37984952
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10660193/
Abstract

INTRODUCTION: Haemophilic arthropathy, a serious complication of haemophilia, results from recurrent joint bleeding, causing progressive joint damage and severely impacting patient quality of life. Rehabilitation therapy (RT) effectively addresses declining physical function due to joint degradation, but pain during RT can hinder its success. Therefore, an effective pain-alleviating treatment method is required. The single-joint hybrid assistive limb (HAL-SJ), a powered exoskeleton, measures bioelectric potential during muscle contraction and provides motorised support, potentially alleviating pain. OBJECTIVE: This study outlines our protocol for a randomised, prospective, single-blind (evaluator) trial aimed to investigate the effects of HAL-SJ on pain reduction during RT, kinesiophobia and other physical functions in patients with haemophilia. METHODS AND ANALYSIS: This two-group comparison intervention study will include 24 male patients aged 12-85 years diagnosed with a bleeding disorder necessitating RT for pain and physical function improvement. The primary outcome measures pain changes during the first and second RT session in patients receiving HAL-SJ-assisted RT compared with traditional RT without HAL-SJ. The secondary outcomes include kinesiophobia (Japanese version of the Tampa Scale for Kinesiophobia), standing position gait (zebris FDM-T treadmill), range of motion (manual goniometer) and body surface temperature (infrared thermography camera) during the study period of up to 3 months or until the end of 10 RTs. RT intensity remains below that required to move the affected joint against gravity, given HAL-SJ's muscular support. The follow-up period extends to 1 month after the last RT. Intergroup study variables are compared by an unpaired t-test or Mann-Whitney test. Intragroup comparisons of secondary outcomes are analysed by a paired t-test or Wilcoxon signed-rank test. ETHICS AND DISSEMINATION: This study was approved by the accreditation committee of Nara Medical University Hospital. The study results will disseminate through publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: jRCTs052220076.

摘要

简介:血友病性关节病是血友病的一种严重并发症,由反复关节出血引起,导致进行性关节损伤,严重影响患者的生活质量。康复治疗(RT)可以有效解决因关节退化导致的身体功能下降问题,但 RT 过程中的疼痛可能会阻碍其成功。因此,需要一种有效的止痛治疗方法。单关节混合辅助肢体(HAL-SJ)是一种动力外骨骼,可以在肌肉收缩时测量生物电势并提供动力支持,从而可能减轻疼痛。

目的:本研究概述了一项随机、前瞻性、单盲(评估者)试验的方案,旨在研究 HAL-SJ 在减轻血友病患者 RT 过程中的疼痛、运动恐惧和其他身体功能方面的效果。

方法和分析:这项两组比较干预研究将纳入 24 名年龄在 12-85 岁之间的男性患者,这些患者患有出血性疾病,需要 RT 来改善疼痛和身体功能。主要结局测量在接受 HAL-SJ 辅助 RT 的患者与未接受 HAL-SJ 的传统 RT 的第一次和第二次 RT 过程中疼痛的变化。次要结局包括研究期间(长达 3 个月或直到 10 次 RT 结束)的运动恐惧(日本版坦帕运动恐惧量表)、站立位步态(zebris FDM-T 跑步机)、关节活动度(手动测角器)和体表温度(红外热像仪相机)。RT 强度保持在不会使受累关节对抗重力移动的水平以下,因为 HAL-SJ 提供肌肉支持。随访期延伸至最后一次 RT 后 1 个月。通过独立样本 t 检验或 Mann-Whitney 检验比较组间研究变量。通过配对 t 检验或 Wilcoxon 符号秩检验分析次要结局的组内比较。

伦理和传播:本研究得到了奈良医科大学医院认证委员会的批准。研究结果将通过发表在同行评议的期刊上进行传播。

注册号:jRCTs052220076。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6528/10660193/9ebc213c62d4/bmjopen-2023-076153f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6528/10660193/73d5652b287c/bmjopen-2023-076153f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6528/10660193/426bf3bf03c3/bmjopen-2023-076153f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6528/10660193/9ebc213c62d4/bmjopen-2023-076153f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6528/10660193/73d5652b287c/bmjopen-2023-076153f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6528/10660193/426bf3bf03c3/bmjopen-2023-076153f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6528/10660193/9ebc213c62d4/bmjopen-2023-076153f03.jpg

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本文引用的文献

[1]
Effects of Physical Therapy on Joint Pain, Joint Range of Motion, Joint Health, Strength, and Mobility in Patients With Hemophilia: A Systematic Review and Meta-analysis.

Am J Phys Med Rehabil. 2023-7-1

[2]
Rehabilitation during early postoperative period following total knee arthroplasty using single-joint hybrid assistive limb as new therapy device: a randomized, controlled clinical pilot study.

Arch Orthop Trauma Surg. 2022-12

[3]
Quality of life and its predictors among adult patients with haemophilic arthropathy. An observational study.

BMC Musculoskelet Disord. 2021-5-15

[4]
Feasibility and efficacy of knee extension training using a single-joint hybrid assistive limb, versus conventional rehabilitation during the early postoperative period after total knee arthroplasty.

J Rural Med. 2021-1

[5]
Feasibility of supplemental robot-assisted knee flexion exercise following total knee arthroplasty.

J Back Musculoskelet Rehabil. 2020

[6]
Pain catastrophizing predicts dropout of patients from an interdisciplinary chronic pain management programme: A prospective cohort study.

J Rehabil Med. 2019-10-29

[7]
Hemophilia A and B: molecular and clinical similarities and differences.

Haematologica. 2019-9

[8]
Manual and educational therapy in the treatment of hemophilic arthropathy of the elbow: a randomized pilot study.

Orphanet J Rare Dis. 2018-9-3

[9]
Training with Hybrid Assistive Limb for walking function after total knee arthroplasty.

J Orthop Surg Res. 2018-7-3

[10]
Health-Related Quality of Life and Association With Arthropathy in Greek Patients with Hemophilia.

Clin Appl Thromb Hemost. 2018-7

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