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A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases

2018年7月18日 更新者:National University Hospital, Singapore
The study is to investigate the effect of a soft robotic glove approach providing continuous passive motion of fingers (flexion and extension) on degenerative arthritis patients. The approach may help reduce pain, maintain mobility and flexibility and to improve hand function.

研究概览

详细说明

The aim is to investigate the effect of soft robotic gloves in providing continuous passive motion of the fingers (finger flexion and extension) of degenerative arthritis patients, for the purpose of providing pain relief and alleviating stiffness at the finger joints. Specifically, we intend to 1) observe the changes in range of motion of the fingers using the Total Active Motion (TAM) measure; 2) observe the changes in grip strength and pinch strength; and 3) record changes in the patients' perception of performance in activities of daily living using the Canadian Occupational Performance Measure (COPM).

The hypothesis is that a soft robotics approach in providing continuous passive motion of the finger joints of degenerative arthritis patients can reduce pain, maintain mobility and flexibility of the joints, and to improve hand function. The soft robotics approach and the standard hand therapy is better than the standard hand therapy alone.

The proposed soft robotic glove is capable of providing continuous passive motion (flexion and extension) of the fingers, and in addition, it is also designed to be portable and easy to operate, with minimal supervision. It is aimed at the home therapy of degenerative arthritis patients. In this study, by using the soft robotic glove and in observing changes in finger range of motion, grip and pinch strength, as well as perception of performance in daily activities. This is important in establishing this device as a viable means to ultimately slow down the progression of degenerative arthritis, and to significantly improve the patients' abilities in carrying out activities of daily living, which had been impaired by degenerative arthritis.

研究类型

介入性

注册 (实际的)

8

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Singapore、新加坡、119074
        • National University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 90年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Aged 30-90 years regardless of race
  2. Osteoarthritis of the hand (Consistent with ACR criteria 1990)
  3. Ability to pay attention and maintain supported sitting for 45 mins continuously
  4. Able to give own consent
  5. Able to comprehend and follow commands (Abbreviated Mental Test >= 7)

Exclusion Criteria:

  1. Inflammatory arthritis (e.g. rheumatoid arthritis), trigger fingers, carpal tunnel syndrome (by symptoms), finger contractures
  2. Recent steroid injections in the wrist/hand joints within the past 3 months
  3. Anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drugs or oral steroid) in the past 1 month
  4. Old stroke and/or spasticity affecting the upper limbs
  5. Epilepsy for the last 6 months as of the date of recruitment
  6. Poor skin conditions which would hamper donning robotic gloves
  7. Pregnancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:设备可行性
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Control Group
This group will receive standard care.
Patients receive standard care
实验性的:Soft Robotic Glove Group
This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).
This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in fingers' Total Active Motion
大体时间:Week 1 baseline assessment and Week 11 post intervention assessment
Measure hand range of motion in which the sum of the extension at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints is subtracted from the total achievable flexion of the same joints. Unit: Degree
Week 1 baseline assessment and Week 11 post intervention assessment
Change in grip and pinch strength
大体时间:Week 1 baseline assessment and Week 11 post intervention assessment
Measure hand strength. Unit: g/kg
Week 1 baseline assessment and Week 11 post intervention assessment

次要结果测量

结果测量
措施说明
大体时间
Change in patient's Canadian Occupational Performance Measure
大体时间:Week 1 baseline assessment and Week 11 post intervention assessment.
Identify issues of personal importance to the patient and to detect changes in a patient's self-perception of occupational performance over time.
Week 1 baseline assessment and Week 11 post intervention assessment.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年10月27日

初级完成 (实际的)

2018年3月14日

研究完成 (实际的)

2018年3月14日

研究注册日期

首次提交

2017年10月24日

首先提交符合 QC 标准的

2017年10月26日

首次发布 (实际的)

2017年10月31日

研究记录更新

最后更新发布 (实际的)

2018年7月19日

上次提交的符合 QC 标准的更新

2018年7月18日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2017/00386

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Control Group的临床试验

3
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