Validation of Rehab Assessments in Myositis Patients

Myositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059394
• Other study ID #: 2014-0022
• Status: Completed
• Phase: N/A
• First received: February 9, 2017
• Last updated: February 20, 2017
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: February 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: August 2015
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myositis

Intervention

Device:
• Non intervention study
Test - Retest of measurements

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantitative Muscle Testing	Hand Held Dynamometer in Newton	15 Minutes
Secondary	Functional Index 2	Evaluates muscle endurance of the upper & lower extremity and neck flexors movements: amount of repetitions.	30 minutes
Secondary	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
Secondary	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
Secondary	Functional Test Battery ( FTB): Walk test ( 4 m)	Time in sec.	Total FTB: 1 1/4 hours
Secondary	Functional Test Battery ( FTB): 1 leg stand	Time in sec.	Total FTB: 1 1/4 hours
Secondary	Functional Test Battery ( FTB): Grip ability Test	Time in sec. (max 60 sec.)	Total FTB: 1 1/4 hours
Secondary	Functional Test Battery ( FTB): Jamar grip test	Strength in Kg.	Total FTB: 1 1/4 hours
Secondary	Functional Test Battery ( FTB): Pile Test	Work = Joule & Performance = Watt	Total FTB: 1 1/4 hours
Secondary	Functional Test Battery ( FTB): 6 Minute walk-test	Meters during 6 minutes	Total FTB: 1 1/4 hours
Secondary	Modified Myositis Activity Profile	34 item Questionnaire	30 Minutes