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

NCT ID: NCT02026245

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-09-30

Brief Summary

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.

Detailed 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.

Conditions

Rheumatoid Arthritis

Keywords

Arthritis; rheumatoid; joints; swelling; measurement; movement; electronic; data; glove; goniometry; outcome; stiffness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

5DT electronic data glove

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

Intervention: Data gloves to perform movements

Group Type: EXPERIMENTAL

Data gloves to perform movements

Intervention Type: DEVICE

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

• 5DT 'dataglove 14 Ultra' Electronic glove (commercially available)
• New 'Tyndall/UU' developmental dataglove

Tyndall/UU electronic data glove

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

Intervention: Data gloves to perform movements

Group Type: EXPERIMENTAL

Data gloves to perform movements

Intervention Type: DEVICE

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

• 5DT 'dataglove 14 Ultra' Electronic glove (commercially available)
• New 'Tyndall/UU' developmental dataglove

Interventions

Data gloves to perform movements

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

• 5DT 'dataglove 14 Ultra' Electronic glove (commercially available)
• New 'Tyndall/UU' developmental dataglove

Intervention Type: DEVICE

Other Intervention Names

5DT; Tyndall/UU dataglove

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Health and Social Care Trust

OTHER

Sponsor Role: collaborator

University of Ulster

OTHER

Sponsor Role: lead

Responsible Party

Dr Joan Condell

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Gardiner, MB BCh MD

Role: PRINCIPAL_INVESTIGATOR

WHSCT

Locations

Western Health and Social Care Trust

Londonderry, , United Kingdom

Countries

United Kingdom

Other Identifiers

Dataglove-02

Identifier Type: -

Identifier Source: org_study_id