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Clinical Trials/NCT02146586
NCT02146586UnknownNot Applicable

Cooperative International Neuromuscular Research Group (CINRG) Clinical Evaluator Outcomes Reliability Study

Cooperative International Neuromuscular Research Group0 sites55 target enrollmentStarted: May 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
55
Primary Endpoint
Clinical Evaluator Assessments

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
6 Years to — (Child, Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Cooperative International Neuromuscular Research Group
Sponsor Class
Network
Responsible Party
Sponsor

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