A Comparison of Two Electronic Goniometric Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The accuracy of joint angle measurement by each electronic goniometric glove will be compared with the accuracy of manual goniometry.
研究概览
简要总结
In this study we will compare two electronic goniometric gloves to see if they can be used in research on joint movement in arthritis.
One of the gloves we will use is the commercially available '5DT Ultra 14 glove', the other is a glove that we have specially designed and developed for use in people with arthritis. Both gloves are 'high-end' gloves with sensors for all of the finger and thumb joints.
We aim to find out if the gloves are accurate and if they can be worn and used without too much discomfort by people with arthritis.
详细描述
This is an open pilot study to assess the usability and accuracy of two electronic goniometric gloves in measuring finger joint movement in patients with Rheumatoid Arthritis.
We will use questionnaires to assess pain, stiffness and disability. We will be using an inner disposable glove worn under the electronic goniometric gloves as this will be important for infection control in clinical use.
We will calibrate the electronic goniometric gloves using wooden blocks at predefined angles using our own software calibration process to optimise the accuracy of the glove for the individual patient.
The patient will flex and extend their fingers repeatedly to get measurements of the minimum and maximum angle of flexion in their joints. During these movements we will also capture the dynamic characteristics of movement such as maximum velocity. In this study a laptop will be used to capture and record all of the measurements from the electronic goniometric glove and record the time at which the measurements were taken.
Each electronic goniometric glove will be refitted for a second set of tests to assess variability due to the fitting process. We will record a full set of data from each set of movements for later analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 to 80
- •Diagnosis of Rheumatoid arthritis
- •Patients who have significant pain and stiffness in their hands
- •Correct hand size to achieve a good fit to the electronic goniometric glove
排除标准
- •Poor fit for the disposable surgical glove
- •Severe pain in the right hand
- •Severe swelling in the right hand (rated as such by the investigator)
- •Major permanent deformities in the right hand
- •Active hyperextension >30 degrees in any joint of the right hand
- •Broken or infected skin in the right hand
- •Known to have tested positive for Methicillin resistant staphylococcus aureus (MRSA) skin infections in the past
- •Unable to don the lining disposable glove without significant discomfort
- •History of Latex allergy
结局指标
主要结局
The accuracy of joint angle measurement by each electronic goniometric glove will be compared with the accuracy of manual goniometry.
时间窗: 1 day
The standard error of measurement for each electronic goniometric glove will be used to evaluate the reliability of each electronic goniometric glove. This will be compared to the standard error of measurement for manual goniometry.
次要结局
- Variation in joint angle movement across sensors - between digits(1 day)
- The variation in joint angle measurement with force applied(1 day)
- We will test the variability of joint angle measurements in wrist extension/flexion(1 day)
- The variability in the measurement of joint movement velocity(1 day)
- The number of patients who prefer one electronic goniometric glove over the other(1 day)
- Variation in joint angle movement between fit and refit(1 day)
- Variability of joint angle measurements by the electronic goniometric gloves will be assessed(1 day)
- The number of patients who withdraw or refuse to continue(1 day)
- Variation in joint angle measurement across the range of movement(1 day)
研究者
Dr Joan Condell
Senior Lecturer
University of Ulster