Validation of Rehab Assessments in Myositis Patients

NCT ID: NCT03059394

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Myositis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Non intervention study

Test - Retest of measurements

Intervention Type DEVICE

Other Intervention Names

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Test retest study

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Baschung Pfister Pierrette, MPH

Role: STUDY_CHAIR

University of Zurich

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2014-0022

Identifier Type: -

Identifier Source: org_study_id

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