Validation of Rehab Assessments in Myositis Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Myositis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Patients with diagnosed inflammatory myopathy
2. Age and gender matched controls

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Muscle Testing	Hand Held Dynamometer in Newton	15 Minutes
Functional Index 2	Evaluates muscle endurance of the upper & lower extremity and neck flexors movements: amount of repetitions.	30 minutes
Functional Test Battery (FTB): Test 1 Self-Performed Physical Performance Test.	Time in seconds to get up and sit down 5 times from a chair.	Total FTB: 1 1/4 hours
Functional Test Battery (FTB): Balance Test	Time in seconds (max 10 sec.) 1) balance feet together, 2) semi-tandem, 3) full-tandem stand.	Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Walk test ( 4 m)	Time in sec.	Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): 1 leg stand	Time in sec.	Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Grip ability Test	Time in sec. (max 60 sec.)	Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Jamar grip test	Strength in Kg.	Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): Pile Test	Work = Joule & Performance = Watt	Total FTB: 1 1/4 hours
Functional Test Battery ( FTB): 6 Minute walk-test	Meters during 6 minutes	Total FTB: 1 1/4 hours
Modified Myositis Activity Profile	34 item Questionnaire	30 Minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2014
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: validity; reliability; measurement error
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Myositis
• Other Study ID Numbers: 2014-0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The dataset analyzed in the current study is available from the corresponding author(s) on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No