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