A Comparison of Two Electronic Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Data gloves to perform movements
Sponsored by
About this trial
This is an interventional health services research trial for Rheumatoid Arthritis focused on measuring Arthritis, rheumatoid, joints, swelling, measurement, movement, electronic, data, glove, goniometry, outcome, stiffness
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
Sites / Locations
- Western Health and Social Care Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
5DT electronic data glove
Tyndall/UU electronic data glove
Arm Description
Using the electronic data gloves to perform a set routine of movements. Intervention: Data gloves to perform movements
Using the electronic data gloves to perform a set routine of movements Intervention: Data gloves to perform movements
Outcomes
Primary Outcome Measures
The accuracy of joint angle measurement by each electronic goniometric glove will be compared with the accuracy of manual goniometry.
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.
Secondary Outcome Measures
The variability in the measurement of joint movement velocity
With rapid repeated movements of finger flexion and extension, the measured maximum velocity of movement should remain fairly constant. The intraclass correlation coefficient will be used to assess the variability in the measurement of joint movement velocity.
Variability of joint angle measurements by the electronic goniometric gloves will be assessed
The Intraclass Correlation coefficient for joint angle measurement will be measured for each electronic goniometric glove
The number of patients who withdraw or refuse to continue
Electronic goniometric gloves may not be easy to don and doff in patients with arthritis, particularly if used with an inner disposable glove. Because of the small numbers we will not apply a statistical analysis
Variation in joint angle movement between fit and refit
If a electronic goniometric glove relies on accurate sensor positioning, refitting may give widely varying results. Each glove will be refitted once.
Variation in joint angle measurement across the range of movement
With use of electronic goniometric gloves, joint angle measurement may be less accurate at the extremes of movement
Variation in joint angle movement across sensors - between digits
Although it may be assumed that the sensors in each digit should perform equally well, the movement of the stretch sensors over the joints may vary between digits. This analysis will test for this variability
The number of patients who prefer one electronic goniometric glove over the other
We will ask the patient which electronic goniometric glove they prefer. This will assess usability factors such as comfort, neatness of fit, and ease of donning and doffing.
The variation in joint angle measurement with force applied
We will use the Intra class correlation test to determine if the accuracy of measurements is affected by the patient gripping tightly against a moulded object held in the palm of their hand.
We will test the variability of joint angle measurements in wrist extension/flexion
We will compare the Intraclass Correlation coefficient for joint angle measurements carried out using the electronic goniometric glove in wrist extension/flexion
Full Information
NCT ID
NCT02026245
First Posted
December 5, 2013
Last Updated
November 4, 2020
Sponsor
University of Ulster
Collaborators
Western Health and Social Care Trust
1. Study Identification
Unique Protocol Identification Number
NCT02026245
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulster
Collaborators
Western Health and Social Care Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Arthritis, rheumatoid, joints, swelling, measurement, movement, electronic, data, glove, goniometry, outcome, stiffness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5DT electronic data glove
Arm Type
Experimental
Arm Description
Using the electronic data gloves to perform a set routine of movements.
Intervention: Data gloves to perform movements
Arm Title
Tyndall/UU electronic data glove
Arm Type
Experimental
Arm Description
Using the electronic data gloves to perform a set routine of movements
Intervention: Data gloves to perform movements
Intervention Type
Device
Intervention Name(s)
Data gloves to perform movements
Other Intervention Name(s)
5DT, Tyndall/UU dataglove
Intervention Description
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
Primary Outcome Measure Information:
Title
The accuracy of joint angle measurement by each electronic goniometric glove will be compared with the accuracy of manual goniometry.
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
The variability in the measurement of joint movement velocity
Description
With rapid repeated movements of finger flexion and extension, the measured maximum velocity of movement should remain fairly constant. The intraclass correlation coefficient will be used to assess the variability in the measurement of joint movement velocity.
Time Frame
1 day
Title
Variability of joint angle measurements by the electronic goniometric gloves will be assessed
Description
The Intraclass Correlation coefficient for joint angle measurement will be measured for each electronic goniometric glove
Time Frame
1 day
Title
The number of patients who withdraw or refuse to continue
Description
Electronic goniometric gloves may not be easy to don and doff in patients with arthritis, particularly if used with an inner disposable glove. Because of the small numbers we will not apply a statistical analysis
Time Frame
1 day
Title
Variation in joint angle movement between fit and refit
Description
If a electronic goniometric glove relies on accurate sensor positioning, refitting may give widely varying results. Each glove will be refitted once.
Time Frame
1 day
Title
Variation in joint angle measurement across the range of movement
Description
With use of electronic goniometric gloves, joint angle measurement may be less accurate at the extremes of movement
Time Frame
1 day
Title
Variation in joint angle movement across sensors - between digits
Description
Although it may be assumed that the sensors in each digit should perform equally well, the movement of the stretch sensors over the joints may vary between digits. This analysis will test for this variability
Time Frame
1 day
Title
The number of patients who prefer one electronic goniometric glove over the other
Description
We will ask the patient which electronic goniometric glove they prefer. This will assess usability factors such as comfort, neatness of fit, and ease of donning and doffing.
Time Frame
1 day
Title
The variation in joint angle measurement with force applied
Description
We will use the Intra class correlation test to determine if the accuracy of measurements is affected by the patient gripping tightly against a moulded object held in the palm of their hand.
Time Frame
1 day
Title
We will test the variability of joint angle measurements in wrist extension/flexion
Description
We will compare the Intraclass Correlation coefficient for joint angle measurements carried out using the electronic goniometric glove in wrist extension/flexion
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Gardiner, MB BCh MD
Organizational Affiliation
WHSCT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Health and Social Care Trust
City
Londonderry
ZIP/Postal Code
BT47 1SB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD may be considered available at a later date, anonymised.
Learn more about this trial
A Comparison of Two Electronic Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis
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