Arthritis, RheumatoidNCT01705834
Dataglove to Measure Joint Stiffness in Patients With Arthritis
An observational study of Arthritis, Rheumatoid, run by Western Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
This study will investigate if an electronic dataglove can be used to measure joint stiffness in patients with Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Rheumatoid
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- Phase
- Observational
- 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
Study population: Patients with Rheumatoid arthritis causing pain and stiffness in their hands.
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 dataglove
- Able to follow instructions for use of dataglove/computer
Who cannot join
- Severe pain in the right hand
- Severe swelling in the right hand (rated as such by the investigator)
- Severe permanent deformity or loss of function in the fingers of the right hand
- Broken or infected skin in the right hand
- Known to have been MRSA positive currently or in the past
- Unable to don and doff the disposable lining glove and the dataglove without significant discomfort
- Poor fit for the disposable lining glove or the dataglove
- History of latex allergy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Rheumatology, Altnagelvin Hospital
Londonderry, N.Ireland, BT47 6SB
About this study
Official title: The Evaluation of a Dataglove to Measure Joint Stiffness in Patients With Arthritis
This study will investigate if an electronic dataglove can be used to measure joint stiffness in patients with Rheumatoid Arthritis.
Read the detailed description
We will use a dataglove to record joint movements in a small number of patients with rheumatoid arthritis. The aim of the study is to find out if changes in dynamic movements measured by the glove will correlate with symptoms of joint stiffness in the hands of patients with rheumatoid arthritis.
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Arthritis, Stiffness, Range of movement, Goniometry, Digital, Dataglove, Outcome
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Arthritis patients | Patients with Rheumatoid Arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between maximum velocity of movement and the patient reported severity of joint stiffness
A significant inverse correlation is expected to be found between the patient's assessment of the severity and/or duration of stiffness and the maximum velocity of movement at the main finger joints.
Measured: Maximum of 7 days
Secondary outcomes (1)
Number of patients withdrawing from the study
We are expecting that no more than 30% of patients will withdraw from the study due to discomfort fitting or using the dataglove.
Measured: Over the period of testing of the dataglove - 7 day timeframe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
Why it stopped: The study protocol has been replaced with a two-glove protocol NCT02026245
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster
- Responsible party
- Principal investigator, Dr Philip Gardiner, Western Health and Social Care Trust
- Investigators
- Philip Gardiner, MB BCh BAO MD, Study chair, Western Health and Social Services TrustKevin Curran, PhD, Principal investigator, University of UlsterJoan Condell, PhD, Principal investigator, University of UlsterJames Connolly, BSc, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705834
- Sponsor's protocol ID
- Dataglove-01
- Status last verified
- Apr 2014
- First submitted
- 4 Oct 2012
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a Dataglove to Measure Joint Stiffness in Patients With Arthritis
- ClinicalTrials.gov ID
- NCT01705834
- Acronym / sponsor ID
- Dataglove-01
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Arthritis, Stiffness, Range of movement, Goniometry, Digital, Dataglove, Outcome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study protocol has been replaced with a two-glove protocol NCT02026245
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western Health and Social Care TrustUniversity, hospital or other
- Collaborators
- University of Ulster
- First posted
- 12 Oct 2012 (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.
This study will investigate if an electronic dataglove can be used to measure joint stiffness in patients with Rheumatoid Arthritis.
Detailed description
We will use a dataglove to record joint movements in a small number of patients with rheumatoid arthritis. The aim of the study is to find out if changes in dynamic movements measured by the glove will correlate with symptoms of joint stiffness in the hands of patients with rheumatoid arthritis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthritis patients | – | –Patients with Rheumatoid Arthritis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Rheumatoid arthritis causing pain and stiffness in their hands.
Key inclusion criteria (5 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 dataglove
- Able to follow instructions for use of dataglove/computer
Key exclusion criteria (8 listed)
- Severe pain in the right hand
- Severe swelling in the right hand (rated as such by the investigator)
- Severe permanent deformity or loss of function in the fingers of the right hand
- Broken or infected skin in the right hand
- Known to have been MRSA positive currently or in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between maximum velocity of movement and the patient reported severity of joint stiffness
Time frame: Maximum of 7 days
A significant inverse correlation is expected to be found between the patient's assessment of the severity and/or duration of stiffness and the maximum velocity of movement at the main finger joints.
1 secondary outcome
Number of patients withdrawing from the study
Time frame: Over the period of testing of the dataglove - 7 day timeframe
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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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 BAO MD study chair
Western Health and Social Services Trust
Kevin Curran, PhD principal investigator
University of Ulster
Joan Condell, PhD principal investigator
University of Ulster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Western Health and Social Care Trust 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 Apr 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation between maximum velocity of movement and the patient reported severity of joint stiffness (time frame: Maximum of 7 days). 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 9 Apr 2014.