Rasch-analysis of Clinical Severity in FSHD (ROC-FSHD)

April 11, 2018 updated by: University of Kansas Medical Center
The purpose of this study is to make a standardized and scalable Rasch-built clinical severity scale to help in finding genetic and environmental modifiers of disease in Facioscapulohumeral muscular dystrophy (FSHD).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Particpants with genetically verified FSHD types 1 and 2.

Description

Inclusion Criteria:

  • Genetic confirmation of FSHD (either FSHD-1 or FSHD-2)

Exclusion Criteria:

  • Do not understand English
  • Unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
FSHD
Participants with FSHD-1 or FSHD-2. No intervention is given to participants. Participants will undergo series of tests and procedures in order to make a standardized and scalable Rasch-built clinical severity scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FSHD Clinical Severity Scale
Time Frame: 1 day
Measure severity of FSHD.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brooks scale
Time Frame: 1 day
Measures upper extremity function.Scores on the scale range from 1-6. A score of 1 means the person can elevate their arms above their head while arms remain straight. 6 means the person cannot elevate their arms to their mouth and do not have useful function of their hands.
1 day
Vignos scale
Time Frame: 1 day
Measures lower extremity function. Scores on the scale range from 1-10. A score of 1 means the person can walk and climb stairs without assistance. A score of 10 means the person is bedridden.
1 day
Iowa Oral Performance Instrument (IOPI)
Time Frame: 1 day
IOPI measures lip and tongue strength by measuring the amount of pressure a person can exert on the tool.
1 day
Manual muscle testing
Time Frame: 1 day
Measure person's range of motion. Scored on a scale with range of 0-5. Score of 0 means no movement. Score of 5 means the person has a full range of movement.
1 day
Quantitative strength testing
Time Frame: 1 day
1 day
Functional testing
Time Frame: 1 day
1 day
Reparatory function testing
Time Frame: 1 day
1 day
Patient-reported outcome
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

April 18, 2017

Study Completion (Actual)

April 18, 2017

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 11, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003640
  • UL1TR000001 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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