Validation of Rehab Assessments in Myositis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validation of Manual Muscle Testing and the Myositis Activity Profile Assessments in Patients With Inflammatory Myositis

Conditions
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Myositis

Intervention / Treatment
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* Device: Non intervention study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Non intervention study|Test - Retest of measurements|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Muscle Testing | Hand Held Dynamometer in Newton | 15 Minutes | 
| Functional Index 2 | Evaluates muscle endurance of the upper & lower extremity and neck flexors movements: amount of repetitions. | 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. | 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. | Total FTB: 1 1/4 hours | 
| Functional Test Battery ( FTB): Walk test ( 4 m) | Time in sec. | Total FTB: 1 1/4 hours | 
| Functional Test Battery ( FTB): 1 leg stand | Time in sec. | Total FTB: 1 1/4 hours | 
| Functional Test Battery ( FTB): Grip ability Test | Time in sec. (max 60 sec.) | Total FTB: 1 1/4 hours | 
| Functional Test Battery ( FTB): Jamar grip test | Strength in Kg. | Total FTB: 1 1/4 hours | 
| Functional Test Battery ( FTB): Pile Test | Work = Joule & Performance = Watt | Total FTB: 1 1/4 hours | 
| Functional Test Battery ( FTB): 6 Minute walk-test | Meters during 6 minutes | Total FTB: 1 1/4 hours | 
| Modified Myositis Activity Profile | 34 item Questionnaire | 30 Minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reliability, validity, measurement error