Clinical Evaluator Outcomes Reliability Study

Cooperative International Neuromuscular Research Group (CINRG)

Status: Unknown

Conditions: Dystrophinopathies

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02146586

CNMC0713

Details and patient eligibility

About

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

Enrollment: 55 estimated patients

Sex: Male

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

55 participants in 3 patient groups

Dystrophinopathies

Gold Standard Clinical Evaluators (GS-CEs)

Sites Clinical Evaluators (CEs)