MyositisNCT03059394
Validation of Rehab Assessments in Myositis Patients
An observational study of Myositis, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of the study is to evaluate the psychometric properties (content and construct validity, reliability, measurements error, as well as possible floor and ceiling effects) of both the assessments MMT8 and the myositis activity profile in patients with IM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myositis
- What is being tested?
- Non intervention study
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to May 2016
- 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
- Adult, Older adult
Study population: 1. Patients with diagnosed inflammatory myopathy 2. Age and gender matched controls
Who may be able to join
- Diagnosis of polymyositis or dermatomyositis or inflammatory myositis associated disorders (e.g. Scleroderma, Systematic lupus erythematosus, Sjögren's syndrome)
- Age over 18
- Sufficiently understanding of German language
- able to understand and follow verbal and written instructions
- signed informed consent to participate in the study
Who cannot join
- Diagnosis of inclusion body myositis
- Pulmonary hypertension
- Osteoporosis
- Severe cardiovascular and/or pulmonary disease
- Pain syndrome
- Paresis
Show all 11Show fewer
- Inclusion Criteria aged and gender matched healthy controls (Systematic lupus erythematosus, Sjögren's syndrome)
- Age over 18
- Sufficiently understanding of German language
- able to understand and follow verbal and written instructions
- signed informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Manual Muscle Testing and the Myositis Activity Profile Assessments in Patients With Inflammatory Myositis
The aim of the study is to evaluate the psychometric properties (content and construct validity, reliability, measurements error, as well as possible floor and ceiling effects) of both the assessments MMT8 and the myositis activity profile in patients with IM.
Read the detailed description
This study evaluates the validity and reliability of two health related instruments that assess disease relevant functions and disabilities in patients with IM: the manual muscle testing 8 (MMT8) and the myositis activity profile (MAP). This study is needed to determine the psychometric properties of these two assessments. Provided that both the MMT8 and the MAP show good psychometric properties, these assessments could be used in the rehabilitation process and intervention programs of patients with IM to determine progress in muscle strength and activity in daily life.
Methodology: Reliability (Test re-test study and validity (cross sectional study) of a short form of MMT 8 and a questionnaire to assess difficulties in activities of daily life (MAP) in myositis patients.
- Conditions
- Myositis
- Being tested
- Non intervention study
- Keywords
- reliability, validity, measurement error
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non intervention studyDevice
Also called Test retest study
Test - Retest of measurements
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Muscle Testing 8 (MMT8)
The strength of 8 Muscle groups is tested in a defined position and rewarded with a score varying from 0 (No visible movement) to 10 (holds test position against strong pressure) and summed for a potential score from 0-80.
Measured: 15 minutes
Secondary outcomes (11)
Quantitative Muscle Testing
Hand Held Dynamometer in Newton
Measured: 15 Minutes
Functional Index 2
Evaluates muscle endurance of the upper \& lower extremity and neck flexors movements: amount of repetitions.
Measured: 30 minutes
Functional Test Battery (FTB): Test 1 Self-Performed Physical Performance Test.
Time in seconds to get up and sit down 5 times from a chair.
Measured: Total FTB: 1 1/4 hours
Functional Test Battery (FTB): Balance Test
Time in seconds (max 10 sec.) 1) balance feet together, 2) semi-tandem, 3) full-tandem stand.
Measured: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Walk test ( 4 m)
Time in sec.
Measured: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): 1 leg stand
Time in sec.
Measured: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Grip ability Test
Time in sec. (max 60 sec.)
Measured: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Jamar grip test
Strength in Kg.
Measured: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Pile Test
Work = Joule \& Performance = Watt
Measured: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): 6 Minute walk-test
Meters during 6 minutes
Measured: Total FTB: 1 1/4 hours
Modified Myositis Activity Profile
34 item Questionnaire
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startMar 2014
- Primary completionAug 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyositisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baschung Pfister Pierrette, MPH, Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059394
- Sponsor's protocol ID
- 2014-0022
- Status last verified
- Feb 2017
- First submitted
- 9 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The dataset analyzed in the current study is available from the corresponding author(s) on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Manual Muscle Testing and the Myositis Activity Profile Assessments in Patients With Inflammatory Myositis
- ClinicalTrials.gov ID
- NCT03059394
- Acronym / sponsor ID
- 2014-0022
- Conditions
- Myositis
- Keywords
- reliability, validity, measurement error
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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 the study is to evaluate the psychometric properties (content and construct validity, reliability, measurements error, as well as possible floor and ceiling effects) of both the assessments MMT8 and the myositis activity profile in patients with IM.
Detailed description
This study evaluates the validity and reliability of two health related instruments that assess disease relevant functions and disabilities in patients with IM: the manual muscle testing 8 (MMT8) and the myositis activity profile (MAP). This study is needed to determine the psychometric properties of these two assessments. Provided that both the MMT8 and the MAP show good psychometric properties, these assessments could be used in the rehabilitation process and intervention programs of patients with IM to determine progress in muscle strength and activity in daily life.
Methodology: Reliability (Test re-test study and validity (cross sectional study) of a short form of MMT 8 and a questionnaire to assess difficulties in activities of daily life (MAP) in myositis patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with diagnosed inflammatory myopathy 2. Age and gender matched controls
Key inclusion criteria (5 listed)
- Diagnosis of polymyositis or dermatomyositis or inflammatory myositis associated disorders (e.g. Scleroderma, Systematic lupus erythematosus, Sjögren's syndrome)
- Age over 18
- Sufficiently understanding of German language
- able to understand and follow verbal and written instructions
- signed informed consent to participate in the study
Key exclusion criteria (11 listed)
- Diagnosis of inclusion body myositis
- Pulmonary hypertension
- Osteoporosis
- Severe cardiovascular and/or pulmonary disease
- Pain syndrome
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 |
|---|---|---|
| Non intervention studyAlso: Test retest studyTest - Retest of measurements | Device | – |
Primary outcome
Manual Muscle Testing 8 (MMT8)
Time frame: 15 minutes
The strength of 8 Muscle groups is tested in a defined position and rewarded with a score varying from 0 (No visible movement) to 10 (holds test position against strong pressure) and summed for a potential score from 0-80.
11 secondary outcomes
Quantitative Muscle Testing
Time frame: 15 Minutes
Functional Index 2
Time frame: 30 minutes
Functional Test Battery (FTB): Test 1 Self-Performed Physical Performance Test.
Time frame: Total FTB: 1 1/4 hours
Functional Test Battery (FTB): Balance Test
Time frame: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Walk test ( 4 m)
Time frame: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): 1 leg stand
Time frame: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Grip ability Test
Time frame: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Jamar grip test
Time frame: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Pile Test
Time frame: Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): 6 Minute walk-test
Time frame: Total FTB: 1 1/4 hours
Modified Myositis Activity Profile
Time frame: 30 Minutes
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 23 Feb 2017.
- Individual participant dataSharing planned: Undecided. The dataset analyzed in the current study is available from the corresponding author(s) on reasonable request.
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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.
Baschung Pfister Pierrette, MPH study chair
University of Zurich
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 Myositis, run by University of Zurich at 1 site in Switzerland.
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 11 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 23 Feb 2017. 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 Switzerland. 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?
Manual Muscle Testing 8 (MMT8) (time frame: 15 minutes). 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 23 Feb 2017.