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Completed

NCT Number: NCT03059394

Validation of Rehab Assessments in Myositis Patients

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.

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Key information

Conditions

Myositis Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non intervention study

Device

Test - Retest of measurements

Other names: Test retest study

Primary outcomes

  1. 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

  1. Quantitative Muscle Testing

    Time frame: 15 Minutes

    Hand Held Dynamometer in Newton

  2. Functional Index 2

    Time frame: 30 minutes

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

  3. Functional Test Battery (FTB): Test 1 Self-Performed Physical Performance Test.

    Time frame: Total FTB: 1 1/4 hours

    Time in seconds to get up and sit down 5 times from a chair.

  4. Functional Test Battery (FTB): Balance Test

    Time frame: Total FTB: 1 1/4 hours

    Time in seconds (max 10 sec.) 1) balance feet together, 2) semi-tandem, 3) full-tandem stand.

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

    Time frame: Total FTB: 1 1/4 hours

    Time in sec.

  6. Functional Test Battery ( FTB): 1 leg stand

    Time frame: Total FTB: 1 1/4 hours

    Time in sec.

  7. Functional Test Battery ( FTB): Grip ability Test

    Time frame: Total FTB: 1 1/4 hours

    Time in sec. (max 60 sec.)

  8. Functional Test Battery ( FTB): Jamar grip test

    Time frame: Total FTB: 1 1/4 hours

    Strength in Kg.

  9. Functional Test Battery ( FTB): Pile Test

    Time frame: Total FTB: 1 1/4 hours

    Work = Joule & Performance = Watt

  10. Functional Test Battery ( FTB): 6 Minute walk-test

    Time frame: Total FTB: 1 1/4 hours

    Meters during 6 minutes

  11. Modified Myositis Activity Profile

    Time frame: 30 Minutes

    34 item Questionnaire

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 23, 2017
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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