Clinical trial NCT03059394: Validation of Rehab Assessments in Myositis Patients
Official title: Validation of Manual Muscle Testing and the Myositis Activity Profile Assessments in Patients With Inflammatory Myositis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myositis
Keywords: reliability
validity
measurement error
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients with diagnosed inflammatory myopathy
2. Age and gender matched controls

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Diagnosis of inclusion body myositis
* Pulmonary hypertension
* Osteoporosis
* Severe cardiovascular and/or pulmonary disease
* Pain syndrome
* Paresis

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

Primary outcomes:
measure: Manual Muscle Testing 8 (MMT8)
timeFrame: 15 minutes
Secondary outcomes:
measure: Quantitative Muscle Testing
timeFrame: 15 Minutes
measure: Functional Index 2
timeFrame: 30 minutes
measure: Functional Test Battery (FTB): Test 1 Self-Performed Physical Performance Test.
timeFrame: Total FTB: 1 1/4 hours
measure: Functional Test Battery (FTB): Balance Test
timeFrame: Total FTB: 1 1/4 hours
measure: Functional Test Battery ( FTB): Walk test ( 4 m)
timeFrame: Total FTB: 1 1/4 hours
measure: Functional Test Battery ( FTB): 1 leg stand
timeFrame: Total FTB: 1 1/4 hours
measure: Functional Test Battery ( FTB): Grip ability Test
timeFrame: Total FTB: 1 1/4 hours
measure: Functional Test Battery ( FTB): Jamar grip test
timeFrame: Total FTB: 1 1/4 hours
measure: Functional Test Battery ( FTB): Pile Test
timeFrame: Total FTB: 1 1/4 hours
measure: Functional Test Battery ( FTB): 6 Minute walk-test
timeFrame: Total FTB: 1 1/4 hours
measure: Modified Myositis Activity Profile
timeFrame: 30 Minutes
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Baschung Pfister Pierrette, MPH
role: STUDY_CHAIR
References: