A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Singapore、新加坡、119074
- National University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 30-90 years regardless of race
- Osteoarthritis of the hand (Consistent with ACR criteria 1990)
- Ability to pay attention and maintain supported sitting for 45 mins continuously
- Able to give own consent
- Able to comprehend and follow commands (Abbreviated Mental Test >= 7)
Exclusion Criteria:
- Inflammatory arthritis (e.g. rheumatoid arthritis), trigger fingers, carpal tunnel syndrome (by symptoms), finger contractures
- Recent steroid injections in the wrist/hand joints within the past 3 months
- Anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drugs or oral steroid) in the past 1 month
- Old stroke and/or spasticity affecting the upper limbs
- Epilepsy for the last 6 months as of the date of recruitment
- Poor skin conditions which would hamper donning robotic gloves
- Pregnancy
学习计划
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 |
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有源比较器:Control Group
This group will receive standard care.
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Patients receive standard care
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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).
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This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).
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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 |
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Change in fingers' Total Active Motion
大体时间:Week 1 baseline assessment and Week 11 post intervention assessment
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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
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Week 1 baseline assessment and Week 11 post intervention assessment
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Change in grip and pinch strength
大体时间:Week 1 baseline assessment and Week 11 post intervention assessment
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Measure hand strength.
Unit: g/kg
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Week 1 baseline assessment and Week 11 post intervention assessment
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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.
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Identify issues of personal importance to the patient and to detect changes in a patient's self-perception of occupational performance over time.
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Week 1 baseline assessment and Week 11 post intervention assessment.
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合作者和调查者
出版物和有用的链接
一般刊物
- Salter RB, Hamilton HW, Wedge JH, Tile M, Torode IP, O'Driscoll SW, Murnaghan JJ, Saringer JH. Clinical application of basic research on continuous passive motion for disorders and injuries of synovial joints: a preliminary report of a feasibility study. J Orthop Res. 1984;1(3):325-42. doi: 10.1002/jor.1100010313.
- Kitay GS, Koren MJ, Helfet DL, Parides MK, Markenson JA. Efficacy of combined local mechanical vibrations, continuous passive motion and thermotherapy in the management of osteoarthritis of the knee. Osteoarthritis Cartilage. 2009 Oct;17(10):1269-74. doi: 10.1016/j.joca.2009.04.015. Epub 2009 May 4.
- Kjeken I, Dagfinrud H, Slatkowsky-Christensen B, Mowinckel P, Uhlig T, Kvien TK, Finset A. Activity limitations and participation restrictions in women with hand osteoarthritis: patients' descriptions and associations between dimensions of functioning. Ann Rheum Dis. 2005 Nov;64(11):1633-8. doi: 10.1136/ard.2004.034900. Epub 2005 Apr 13.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
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Control Group的临床试验
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Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的肥胖 | 心血管危险因素 | 糖尿病风险
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Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology, Portugal; Institute...招聘中
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Devicare S.L.Clever Instruments S.L.; Fundacio Puigvert未知
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Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)招聘中
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Gonzalez-Heydrich, Joseph, M.D.Boston Children's Hospital; Harvard University完全的
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Amsterdam UMC, location VUmcRed Cross Hospital Beverwijk完全的