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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01125709
Registration number
NCT01125709
Ethics application status
Date submitted
17/05/2010
Date registered
18/05/2010
Date last updated
11/01/2013
Titles & IDs
Public title
Comparative Study of Clinical Endpoint in DMD: Handheld Myometry (HHM) Versus CINRG Quantitative Measurement System (CQMS)
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Scientific title
Comparative Study of Clinical Endpoint in DMD: HHM vs. CQMS
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Secondary ID [1]
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CNMC0609
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Duchenne Muscular Dystrophy
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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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).
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Timepoint [1]
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two-day visit
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Eligibility
Key inclusion criteria
Participants should meet the following criteria:
1. Confirmed clinical and molecular diagnosis of DMD
2. 6- 18 years of age
3. Ability to follow 2 step instructions
4. Ability to transfer to and from the wheelchair-mat with moderate assistance defined as no greater than 75% assistance.
5. Signed informed consent of parental or legal guardian(s) is required for participants. Assent from children 7-18 years old may also required.
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Minimum age
6
Years
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Maximum age
18
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants must confirm:
1. No Surgical procedures were performed = 8 weeks before study procedures.
2. No musculoskeletal injuries were experienced = 8 weeks before study procedures.
3. Investigator assessment that patient or parent/legal guardian are not willing or able to comply with study procedures.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2010
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Children's Hospital - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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District of Columbia
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Country [2]
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United States of America
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State/province [2]
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Missouri
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United States of America
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State/province [3]
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North Carolina
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Country [4]
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Italy
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State/province [4]
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Milano
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Funding & Sponsors
Primary sponsor type
Other
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Name
Cooperative International Neuromuscular Research Group
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Muscular Dystrophy Association
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Children's National Research Institute
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Washington University School of Medicine
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Royal Children's Hospital
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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Sydney Children's Hospitals Network
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Address [5]
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Other collaborator category [6]
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Other
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Name [6]
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Fondazione Serena Onlus - Centro Clinico NeMO Milano
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Address [6]
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Other collaborator category [7]
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Other
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Name [7]
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Carolinas Medical Center
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Address [7]
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Country [7]
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of the proposed research is to compare two commonly used pediatric strength testing measures: handheld myometry (HHM) and CINRG Quantitative Measurement System (CQMS), with the goal of identifying a sensitive and valid tool for measuring muscle strength in children with DMD. The data obtained from this study will be used to make recommendations for strength measurement endpoints in prospective muscular dystrophy trials and provide more reliable and accurate recommendations in the clinic for strength assessment. This study will be performed at six participating sites in the Cooperative International Neuromuscular Research Group (CINRG).
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Trial website
https://clinicaltrials.gov/study/NCT01125709
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tina T Duong, MPT
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Address
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Children's National Research Institute
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01125709
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