Comparative Study of Clinical Endpoint in DMD: Handheld Myometry (HHM) Versus CINRG Quantitative Measurement System (CQMS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01125709|
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : January 11, 2013
|Condition or disease|
|Duchenne Muscular Dystrophy|
We propose to compare the reliability of CQMS vs. HHM in the DMD population. The importance of this study is to be able to compare the results of clinical trials done by different networks using distinct strength endpoints. If results indicate a distinct difference in reliability of one tool over the other, a standardized tool could be established for research groups throughout the world to interpret strength in the context of clinical trials. If the results indicate minor differences then it would be possible to interpret and compare/contrast strength measurements used in different studies.
Understanding the relationship between the HHM vs CQMS will help us examine other surrogate measures capable of predicting functionality that are based on strength measurements.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Comparative Study of Clinical Endpoint in DMD: HHM vs. CQMS|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||August 2010|
- Compare the inter and intra rater reliability of HHM and CQMS by measuring Elbow and Knee Flexor/Extensor Strength in children ages 6-18 diagnosed with DMD tested by experienced clinical evaluators in both HHM and CQMS. [ Time Frame: two-day visit ]Muscle groups will be tested in a standardized order 1. Knee extension 2. Knee flexion 3. Elbow Flexion 4. Elbow extension with all tests sequencing following a right to left pattern. This will reduce assessment bias and the impact of muscle fatigue per muscle group. Study participants are randomized to two different sequences of four assessments, one sequence performed on one testing day (Visit 1) and another on a different testing day (Visit 2).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125709
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Missouri|
|Washington University - St. Louis|
|St. Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28207|
|Royal Children's Hospital|
|Parkville, Victoria, Australia, 3052|
|Centro Clinico Nemo|
|Milano, Italy, 20162|
|Principal Investigator:||Tina T Duong, MPT||Children's Research Institute|