Clinical trial NCT02026245: A Comparison of Two Electronic Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis
Official title: A Comparison of Two Electronic Goniometric Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Arthritis
rheumatoid
joints
swelling
measurement
movement
electronic
data
glove
goniometry
outcome
stiffness
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Western Health and Social Care Trust
First posted: 2014-01-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: The accuracy of joint angle measurement by each electronic goniometric glove will be compared with the accuracy of manual goniometry.
timeFrame: 1 day
Secondary outcomes:
measure: The variability in the measurement of joint movement velocity
timeFrame: 1 day
measure: Variability of joint angle measurements by the electronic goniometric gloves will be assessed
timeFrame: 1 day
measure: The number of patients who withdraw or refuse to continue
timeFrame: 1 day
measure: Variation in joint angle movement between fit and refit
timeFrame: 1 day
measure: Variation in joint angle measurement across the range of movement
timeFrame: 1 day
measure: Variation in joint angle movement across sensors - between digits
timeFrame: 1 day
measure: The number of patients who prefer one electronic goniometric glove over the other
timeFrame: 1 day
measure: The variation in joint angle measurement with force applied
timeFrame: 1 day
measure: We will test the variability of joint angle measurements in wrist extension/flexion
timeFrame: 1 day
Other outcomes:
Locations:
city: Londonderry
country: United Kingdom
facility: Western Health and Social Care Trust
Study officials:
affiliation: WHSCT
name: Philip Gardiner, MB BCh MD
role: PRINCIPAL_INVESTIGATOR
References: