Validation of Rehab Assessments in Myositis Patients

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT03059394
Collaborator
(none)
50
1
26
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Non intervention study

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.

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Validation of Manual Muscle Testing and the Myositis Activity Profile Assessments in Patients With Inflammatory Myositis
Actual Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
May 1, 2016

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Quantitative Muscle Testing [15 Minutes]

    Hand Held Dynamometer in Newton

  2. Functional Index 2 [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. [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 [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) [Total FTB: 1 1/4 hours]

    Time in sec.

  6. Functional Test Battery ( FTB): 1 leg stand [Total FTB: 1 1/4 hours]

    Time in sec.

  7. Functional Test Battery ( FTB): Grip ability Test [Total FTB: 1 1/4 hours]

    Time in sec. (max 60 sec.)

  8. Functional Test Battery ( FTB): Jamar grip test [Total FTB: 1 1/4 hours]

    Strength in Kg.

  9. Functional Test Battery ( FTB): Pile Test [Total FTB: 1 1/4 hours]

    Work = Joule & Performance = Watt

  10. Functional Test Battery ( FTB): 6 Minute walk-test [Total FTB: 1 1/4 hours]

    Meters during 6 minutes

  11. Modified Myositis Activity Profile [30 Minutes]

    34 item Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Zurich Zurich Switzerland 8091

Sponsors and Collaborators

  • University of Zurich

Investigators

  • Study Chair: Baschung Pfister Pierrette, MPH, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Zurich
ClinicalTrials.gov Identifier:
NCT03059394
Other Study ID Numbers:
  • 2014-0022
First Posted:
Feb 23, 2017
Last Update Posted:
Feb 23, 2017
Last Verified:
Feb 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Zurich
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2017