- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02026245
A Comparison of Two Electronic Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis
A Comparison of Two Electronic Goniometric Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Londonderry, United Kingdom, BT47 1SB
- Western Health and Social Care Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 5DT electronic data glove
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:
Other Names:
|
Experimental: Tyndall/UU electronic data glove
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:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The accuracy of joint angle measurement by each electronic goniometric glove will be compared with the accuracy of manual goniometry.
Time Frame: 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.
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1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The variability in the measurement of joint movement velocity
Time Frame: 1 day
|
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.
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1 day
|
Variability of joint angle measurements by the electronic goniometric gloves will be assessed
Time Frame: 1 day
|
The Intraclass Correlation coefficient for joint angle measurement will be measured for each electronic goniometric glove
|
1 day
|
The number of patients who withdraw or refuse to continue
Time Frame: 1 day
|
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
|
1 day
|
Variation in joint angle movement between fit and refit
Time Frame: 1 day
|
If a electronic goniometric glove relies on accurate sensor positioning, refitting may give widely varying results.
Each glove will be refitted once.
|
1 day
|
Variation in joint angle measurement across the range of movement
Time Frame: 1 day
|
With use of electronic goniometric gloves, joint angle measurement may be less accurate at the extremes of movement
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1 day
|
Variation in joint angle movement across sensors - between digits
Time Frame: 1 day
|
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
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1 day
|
The number of patients who prefer one electronic goniometric glove over the other
Time Frame: 1 day
|
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.
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1 day
|
The variation in joint angle measurement with force applied
Time Frame: 1 day
|
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.
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1 day
|
We will test the variability of joint angle measurements in wrist extension/flexion
Time Frame: 1 day
|
We will compare the Intraclass Correlation coefficient for joint angle measurements carried out using the electronic goniometric glove in wrist extension/flexion
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1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip Gardiner, MB BCh MD, WHSCT
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dataglove-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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