Rheumatoid ArthritisNCT02026245
A Comparison of Two Electronic Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis
A study testing Data gloves to perform movements in people with Rheumatoid Arthritis, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Data gloves to perform movements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Western Health and Social Care Trust
Londonderry, BT47 1SB
About this study
Official title: 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.
Read the 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
- Being tested
- Data gloves to perform movements
- Keywords
- Arthritis, rheumatoid, joints, swelling, measurement, movement, electronic, data, glove, goniometry, outcome, stiffness
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data gloves to perform movementsDevice
Also called 5DT, Tyndall/UU dataglove
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
| Study group | Role | What they receive |
|---|---|---|
| 5DT electronic data glove | Experimental | Using the electronic data gloves to perform a set routine of movements.
Intervention: Data gloves to perform movements Receives: Device: Data gloves to perform movements |
| Tyndall/UU electronic data glove | Experimental | Using the electronic data gloves to perform a set routine of movements
Intervention: Data gloves to perform movements Receives: Device: Data gloves to perform movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (9)
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.
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
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.
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startAug 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Western Health and Social Care Trust
- Responsible party
- Principal investigator, Dr Joan Condell, University of Ulster
- Investigators
- Philip Gardiner, MB BCh MD, Principal investigator, WHSCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026245
- Sponsor's protocol ID
- Dataglove-02
- Status last verified
- Nov 2020
- First submitted
- 5 Dec 2013
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: IPD may be considered available at a later date, anonymised.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Electronic Goniometric Gloves in the Measurement of Joint Movement in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02026245
- Acronym / sponsor ID
- Dataglove-02
- Conditions
- Rheumatoid Arthritis
- Keywords
- Arthritis, rheumatoid, joints, swelling, measurement, movement, electronic, data
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Western Health and Social Care Trust
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5DT electronic data glove | Experimental | Device: Data gloves to perform movementsUsing the electronic data gloves to perform a set routine of movements. Intervention: Data gloves to perform movements |
| Tyndall/UU electronic data glove | Experimental | Device: Data gloves to perform movementsUsing the electronic data gloves to perform a set routine of movements Intervention: Data gloves to perform movements |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data gloves to perform movementsAlso: 5DT, Tyndall/UU datagloveUsing the electronic data gloves to perform a set routine of movements: * 5DT 'dataglove 14 Ultra' Electronic glove (commercially available) * New 'Tyndall/UU' developmental dataglove | Device | 5DT electronic data glove, Tyndall/UU electronic data glove |
Primary outcome
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.
9 secondary outcomes
The variability in the measurement of joint movement velocity
Time frame: 1 day
Variability of joint angle measurements by the electronic goniometric gloves will be assessed
Time frame: 1 day
The number of patients who withdraw or refuse to continue
Time frame: 1 day
Variation in joint angle movement between fit and refit
Time frame: 1 day
Variation in joint angle measurement across the range of movement
Time frame: 1 day
Variation in joint angle movement across sensors - between digits
Time frame: 1 day
The number of patients who prefer one electronic goniometric glove over the other
Time frame: 1 day
The variation in joint angle measurement with force applied
Time frame: 1 day
We will test the variability of joint angle measurements in wrist extension/flexion
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No. IPD may be considered available at a later date, anonymised.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Gardiner, MB BCh MD principal investigator
WHSCT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data gloves to perform movements in people with Rheumatoid Arthritis, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of joint angle measurement by each electronic goniometric glove will be compared with the accuracy of manual goniometry. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.