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Clinical Trials/NCT03059394
NCT03059394
Completed
Not Applicable

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

University of Zurich1 site in 1 country50 target enrollmentMarch 2014
ConditionsMyositis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myositis
Sponsor
University of Zurich
Enrollment
50
Locations
1
Primary Endpoint
Manual Muscle Testing 8 (MMT8)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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
  • 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

Outcomes

Primary Outcomes

Manual Muscle Testing 8 (MMT8)

Time Frame: 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 Outcomes

  • Functional Index 2(30 minutes)
  • Functional Test Battery (FTB): Test 1 Self-Performed Physical Performance Test.(Total FTB: 1 1/4 hours)
  • Functional Test Battery (FTB): Balance Test(Total FTB: 1 1/4 hours)
  • Quantitative Muscle Testing(15 Minutes)
  • Functional Test Battery ( FTB): Walk test ( 4 m)(Total FTB: 1 1/4 hours)
  • Functional Test Battery ( FTB): 6 Minute walk-test(Total FTB: 1 1/4 hours)
  • Modified Myositis Activity Profile(30 Minutes)
  • Functional Test Battery ( FTB): 1 leg stand(Total FTB: 1 1/4 hours)
  • Functional Test Battery ( FTB): Grip ability Test(Total FTB: 1 1/4 hours)
  • Functional Test Battery ( FTB): Jamar grip test(Total FTB: 1 1/4 hours)
  • Functional Test Battery ( FTB): Pile Test(Total FTB: 1 1/4 hours)

Study Sites (1)

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