A Comparison of Two Electronic Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis

Ulster University

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Device: Data gloves to perform movements

Study type: Interventional

Funder types: Other

Identifiers

NCT02026245

Dataglove-02

Details and patient eligibility

About

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.

Full description

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.

Finally, we will assess usability and establish if patients have a preference between the two electronic goniometric gloves.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

12 participants in 2 patient groups

5DT electronic data glove

Experimental group

Description:

Using the electronic data gloves to perform a set routine of movements. Intervention: Data gloves to perform movements

Treatment:

Device: Data gloves to perform movements

Tyndall/UU electronic data glove

Experimental group

Description:

Using the electronic data gloves to perform a set routine of movements Intervention: Data gloves to perform movements

Treatment:

Device: Data gloves to perform movements