Clinical Trial: Validation of Rehab Assessments in Myositis Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.


Sponsor: University of Zurich

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quantitative Muscle Testing [ Time Frame: 15 Minutes ]
    Hand Held Dynamometer in Newton
  • Functional Index 2 [ Time Frame: 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. [ Time Frame: 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 [ 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.
  • Functional Test Battery ( FTB): Walk test ( 4 m) [ Time Frame: Total FTB: 1 1/4 hours ]
    Time in sec.
  • Functional Test Battery ( FTB): 1 leg stand [ Time Frame: Total FTB: 1 1/4 hours ]
    Time in sec.
  • Functional Test Battery ( FTB): Grip ability Test [ Time Frame: Total FTB: 1 1/4 hours ]
    Time in sec. (max 60 sec.)
  • Functional Test Battery ( FTB): Jamar grip test [ Time Frame: Total FTB: 1 1/4 hours ]
    Strength in Kg.
  • Functional Test Battery ( FTB): Pile Test [ Time Frame: Total FTB: 1 1/4 hours ]
    Work = Joule & Performance = Watt
  • Functional Test Battery ( FTB): 6 Minute walk-test [ Time Frame: Total FTB: 1 1/4 hours ]
    Meters during 6 minutes
  • Modified Myositis Activity Profile [ Time Frame: 30 Minutes ]
    34 item Questionnaire


Original Secondary Outcome: Same as current

Information By: University of Zurich

Dates:
Date Received: February 9, 2017
Date Started: March 2014
Date Completion:
Last Updated: February 20, 2017
Last Verified: February 2017