PolymyositisNCT00866125
Hand Function in Patients With Poly- or Dermatomyositis
An observational study of Polymyositis and Dermatomyositis, run by Karolinska Institutet.
Trial summary
The aim of this study is to investigate the hand function in patients with poly-and dermatomyositis and compare this to healthy individuals and norm values and secondly if hand function correlates to activity performance and health related quality of life. The study is a cross-sectional study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polymyositis, Dermatomyositis
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Aug 2002
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 50 patients diagnosed with polymyositis or dermatomyositis were identified through the myositis registry at the rheumatology clinic at Karolinska University Hospital, Stockholm, Sweden.
Who may be able to join
- Patients with definite or probable polymyositis or dermatomyositis (according to criteria by Bohan and Peter) were included in the study
Who cannot join
- Other diseases or injuries that could affect arm/hand mobility and grip force for example other rheumatological or neurological disease.
About this study
Official title: Hand Function, Health Related Quality of Life and Activity Performance in Patients With Polymyositis or Dermatomyositis.
The aim of this study is to investigate the hand function in patients with poly-and dermatomyositis and compare this to healthy individuals and norm values and secondly if hand function correlates to activity performance and health related quality of life.
The study is a cross-sectional study. To assess hand function the investigators will measure grip force with Grippit and arm/hand mobility using EPM-ROM scale. The activity performance will be measured with Myositis Activities Profile and health related quality of life will be assessed with SF-36.
The investigators' hypothesis is that hand function is reduced in comparison to the healthy population and that hand function affects both activity performance and health related quality of life.
- Conditions
- Polymyositis, Dermatomyositis
- Keywords
- Polymyositis, Dermatomyositis, Grip force, Quality of life, Activity performance
- Medical subject headings
- Polymyositis, Dermatomyositis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startApr 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolymyositisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Investigators
- Ingrid E Lundberg, MD, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866125
- Sponsor's protocol ID
- 02-078
- Status last verified
- Mar 2009
- First submitted
- 19 Mar 2009
- Last updated
- 20 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Function, Health Related Quality of Life and Activity Performance in Patients With Polymyositis or Dermatomyositis.
- ClinicalTrials.gov ID
- NCT00866125
- Acronym / sponsor ID
- 02-078
- Conditions
- Polymyositis, Dermatomyositis
- Keywords
- Polymyositis, Dermatomyositis, Grip force, Quality of life, Activity performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- Aug 2002 (actual)
- First posted
- 20 Mar 2009 (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.
The aim of this study is to investigate the hand function in patients with poly-and dermatomyositis and compare this to healthy individuals and norm values and secondly if hand function correlates to activity performance and health related quality of life.
The study is a cross-sectional study. To assess hand function the investigators will measure grip force with Grippit and arm/hand mobility using EPM-ROM scale. The activity performance will be measured with Myositis Activities Profile and health related quality of life will be assessed with SF-36.
The investigators' hypothesis is that hand function is reduced in comparison to the healthy population and that hand function affects both activity performance and health related quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 patients diagnosed with polymyositis or dermatomyositis were identified through the myositis registry at the rheumatology clinic at Karolinska University Hospital, Stockholm, Sweden.
Key inclusion criteria (1 listed)
- Patients with definite or probable polymyositis or dermatomyositis (according to criteria by Bohan and Peter) were included in the study
Key exclusion criteria (1 listed)
- Other diseases or injuries that could affect arm/hand mobility and grip force for example other rheumatological or neurological disease.
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
Not reported in the source record.
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 20 Mar 2009.
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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.
Ingrid E Lundberg, MD, PhD study director
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Polymyositis and Dermatomyositis, run by Karolinska Institutet.
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 1 inclusion and 1 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 20 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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 20 Mar 2009.