Clinical Evaluator Outcomes Reliability Study

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02146586

Enrollment

Registered

2014-05-26

Start date

2014-05-31

Completion date

2016-12-31

Last updated

2016-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystrophinopathies

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

6 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Clinical Evaluator Assessments	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.

Outcome results