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Validation of Rehab Assessments in Myositis Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03059394
Enrollment
50
Registered
2017-02-23
Start date
2014-03-31
Completion date
2016-05-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myositis

Keywords

reliability, validity, measurement error

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.

Interventions

Test - Retest of measurements

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Manual Muscle Testing 8 (MMT8)15 minutesThe 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

MeasureTime frameDescription
Functional Index 230 minutesEvaluates 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 hoursTime in seconds to get up and sit down 5 times from a chair.
Functional Test Battery (FTB): Balance TestTotal FTB: 1 1/4 hoursTime in seconds (max 10 sec.) 1) balance feet together, 2) semi-tandem, 3) full-tandem stand.
Functional Test Battery ( FTB): Walk test ( 4 m)Total FTB: 1 1/4 hoursTime in sec.
Functional Test Battery ( FTB): 1 leg standTotal FTB: 1 1/4 hoursTime in sec.
Quantitative Muscle Testing15 MinutesHand Held Dynamometer in Newton
Functional Test Battery ( FTB): Jamar grip testTotal FTB: 1 1/4 hoursStrength in Kg.
Functional Test Battery ( FTB): Pile TestTotal FTB: 1 1/4 hoursWork = Joule & Performance = Watt
Functional Test Battery ( FTB): 6 Minute walk-testTotal FTB: 1 1/4 hoursMeters during 6 minutes
Modified Myositis Activity Profile30 Minutes34 item Questionnaire
Functional Test Battery ( FTB): Grip ability TestTotal FTB: 1 1/4 hoursTime in sec. (max 60 sec.)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026