Validation of Rehab Assessments in Myositis Patients
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|ClinicalTrials.gov Identifier: NCT03059394|
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment|
|Myositis||Device: Non intervention study|
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|
|Actual Enrollment :||50 participants|
|Official Title:||Validation of Manual Muscle Testing and the Myositis Activity Profile Assessments in Patients With Inflammatory Myositis|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||May 2016|
Device: Non intervention study
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059394
|University Hospital Zurich|
|Zurich, Switzerland, 8091|
|Study Chair:||Baschung Pfister Pierrette, MPH||University of Zurich|