Validation of Rehab Assessments in Myositis Patients

University of Zurich50 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Myositis

Interventions

Non intervention studyDEVICE

Test - Retest of measurements

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 15 minutes

Secondary Outcomes

Quantitative Muscle Testing

Hand Held Dynamometer in Newton

Time frame: 15 Minutes

Functional Index 2

Evaluates muscle endurance of the upper \& lower extremity and neck flexors movements: amount of repetitions.

Time frame: 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.

Time frame: 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.

Time frame: Total FTB: 1 1/4 hours

Functional Test Battery ( FTB): Walk test ( 4 m)

Time in sec.

Time frame: Total FTB: 1 1/4 hours

Functional Test Battery ( FTB): 1 leg stand

Time in sec.

Time frame: Total FTB: 1 1/4 hours

Functional Test Battery ( FTB): Grip ability Test

Time in sec. (max 60 sec.)

Data from ClinicalTrials.gov

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