Validation of Rehab Assessments in Myositis Patients | NCT03059394

Studies
Validation of Rehab Assessments in Myositis Patients

NCT03059394

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Myositis

Interventions

Non intervention study

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014Actual

Primary Completion Date

Aug 2015Actual

Completion Date

May 2016Actual

First Submitted Date

Feb 9, 2017

First Submission Date that Met QC Criteria

Feb 20, 2017

First Posted Date

Feb 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2017

Last Update Posted Date

Feb 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
Non intervention study	Device	Test - Retest of measurements		Test retest study

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with diagnosed inflammatory myopathy
Age and gender matched controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Baschung Pfister Pierrette, MPH	University of Zurich	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich		Zurich		8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The dataset analyzed in the current study is available from the corresponding author(s) on reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009220	Myositis

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

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Browse Branches

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