Validation of Rehab Assessments in Myositis Patients
- Conditions
- Myositis
- Registration Number
- NCT03059394
- Lead Sponsor
- University of Zurich
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Manual Muscle Testing 8 (MMT8) 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.
- Secondary Outcome Measures
Name Time Method Functional Index 2 30 minutes Evaluates muscle endurance of the upper \& lower extremity and neck flexors movements: amount of repetitions.
Functional Test Battery (FTB): Test 1 Self-Performed Physical Performance Test. Total FTB: 1 1/4 hours Time in seconds to get up and sit down 5 times from a chair.
Functional Test Battery (FTB): Balance Test Total FTB: 1 1/4 hours Time in seconds (max 10 sec.) 1) balance feet together, 2) semi-tandem, 3) full-tandem stand.
Quantitative Muscle Testing 15 Minutes Hand Held Dynamometer in Newton
Functional Test Battery ( FTB): Walk test ( 4 m) Total FTB: 1 1/4 hours Time in sec.
Modified Myositis Activity Profile 30 Minutes 34 item Questionnaire
Functional Test Battery ( FTB): 1 leg stand Total FTB: 1 1/4 hours Time in sec.
Functional Test Battery ( FTB): Grip ability Test Total FTB: 1 1/4 hours Time in sec. (max 60 sec.)
Functional Test Battery ( FTB): Jamar grip test Total FTB: 1 1/4 hours Strength in Kg.
Functional Test Battery ( FTB): Pile Test Total FTB: 1 1/4 hours Work = Joule \& Performance = Watt
Functional Test Battery ( FTB): 6 Minute walk-test Total FTB: 1 1/4 hours Meters during 6 minutes
Trial Locations
- Locations (1)
University Hospital Zurich
🇨🇭Zurich, Switzerland