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Validation of Rehab Assessments in Myositis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT03059394
First received: February 9, 2017
Last updated: February 20, 2017
Last verified: February 2017
  Purpose
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 Intervention
Myositis Device: Non intervention study

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Validation of Manual Muscle Testing and the Myositis Activity Profile Assessments in Patients With Inflammatory Myositis

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 50
Actual Study Start Date: March 2014
Study Completion Date: May 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Non intervention study
    Test - Retest of measurements
    Other Name: Test retest 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients with diagnosed inflammatory myopathy
  2. Age and gender matched controls
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03059394

Locations
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Study Chair: Baschung Pfister Pierrette, MPH University of Zurich
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03059394     History of Changes
Other Study ID Numbers: 2014-0022
Study First Received: February 9, 2017
Last Updated: February 20, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The dataset analyzed in the current study is available from the corresponding author(s) on reasonable request.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
reliability
validity
measurement error

Additional relevant MeSH terms:
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 21, 2017