Validation of Rehab Assessments in Myositis Patients
Validation of Manual Muscle Testing and the Myositis Activity Profile Assessments in Patients With Inflammatory Myositis
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 9, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedFebruary 23, 2017
February 1, 2017
1.4 years
February 9, 2017
February 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Manual Muscle Testing 8 (MMT8)
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.
15 minutes
Secondary Outcomes (11)
Quantitative Muscle Testing
15 Minutes
Functional Index 2
30 minutes
Functional Test Battery (FTB): Test 1 Self-Performed Physical Performance Test.
Total FTB: 1 1/4 hours
Functional Test Battery (FTB): Balance Test
Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Walk test ( 4 m)
Total FTB: 1 1/4 hours
- +6 more secondary outcomes
Interventions
Eligibility Criteria
1. Patients with diagnosed inflammatory myopathy 2. Age and gender matched controls
You may qualify if:
- 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
You may not qualify if:
- Pulmonary hypertension
- Osteoporosis
- Severe cardiovascular and/or pulmonary disease
- Pain syndrome
- Paresis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Baschung Pfister Pierrette, MPH
University of Zurich
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2017
First Posted
February 23, 2017
Study Start
March 1, 2014
Primary Completion
August 1, 2015
Study Completion
May 1, 2016
Last Updated
February 23, 2017
Record last verified: 2017-02