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Clinical Evaluator Outcomes Reliability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02146586
Recruitment Status : Active, not recruiting
First Posted : May 26, 2014
Last Update Posted : February 2, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study outlines structured Clinical Evaluator (CE) testing techniques that are proposed to be implemented across all sites participating in the Cooperative International Neuromuscular Research Group (CINRG) research studies. The study will determine if the selected techniques are reliable and reproducible across the CINRG network by evaluating the reliability and reproducibility of the measures between CEs

Condition or disease

Study Design

Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cooperative International Neuromuscular Research Group (CINRG) Clinical Evaluator Outcomes Reliability Study
Study Start Date : May 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Gold Standard Clinical Evaluators (GS-CEs)
Sites Clinical Evaluators (CEs)

Outcome Measures

Primary Outcome Measures :
  1. Clinical Evaluator Assessments [ Time Frame: One time visit ]

    The following assessments are conducted by certified physical therapists: Anthropometrics, goniometry, Brooke upper extremity and Vignos lower extremity scales, Performance Upper Limb Scale (PULS), North Star Ambulatory Assessment (NSAA), Six Minute Walk Test (6MWT), time to rise from floor, time to stand from a chair, time to climb four stairs, time to walk/run 10 meters, 9 Hole Peg Test (9HPT), Quantitative Muscle Tests (QMT), Manual Muscle testing (MMT), Force Vital Capacity (FVC), Force Expiratory Volume (FEV1), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), Peak Expiratory Flow Rate (PEFR) and Peak Cough Flow (PCF).

    The reliability of these commonly used measurements is fundamental to clinical research, our ability to have confidence in the data we collect and our ability to draw rational conclusions from the data.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dystrophinopathies (Duchenne Muscular Dystrophy and Becker Muscular Dystrophy)

Dystrophinopathy Participant Inclusion Criteria:

  • Site confirmed genetic diagnosis of a dystrophinopathy
  • Aged 6 years and older
  • Able to transfer to testing table
  • Able to walk 10 meters without an assistive device

Dystrophinopathy Participant Exclusion Criteria:

  • Investigator assessment of inability to comply with protocol assessments
  • Participants who have attention deficient disorder or other cognitive conditions that may limit attention span to perform protocol assessments
Contacts and Locations

Information from the National Library of Medicine

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): NCT02146586

Sponsors and Collaborators
Cooperative International Neuromuscular Research Group
Principal Investigator: Lauren Morgenroth, MS, CGC Children's Research Institute
Principal Investigator: Tina Duong, MPT Stanford University
More Information

Responsible Party: Cooperative International Neuromuscular Research Group
ClinicalTrials.gov Identifier: NCT02146586     History of Changes
Other Study ID Numbers: CNMC0713
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016