Clinical Evaluator Outcomes Reliability Study

NCT02146586 | Unknown DMC

• 1 other identifier: CNMC0713
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

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

Conditions

Dystrophinopathies

Outcome Measures

Primary Outcomes (1)

• Clinical Evaluator Assessments

  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.

  One time visit

Study Arms (3)

Dystrophinopathies

Gold Standard Clinical Evaluators (GS-CEs)

Sites Clinical Evaluators (CEs)

Eligibility Criteria

• Age: 6 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dystrophinopathies (Duchenne Muscular Dystrophy and Becker Muscular Dystrophy)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cooperative International Neuromuscular Research Group: lead

Study Officials

• Lauren Morgenroth, MS, CGC

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

• Tina Duong, MPT

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 26, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 2, 2016

Record last verified: 2016-02