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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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)
Scientific title
Comparative Study of Clinical Endpoint in DMD: HHM vs. CQMS
Secondary ID [1] 0 0
CNMC0609
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Duchenne Muscular Dystrophy 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
two-day visit

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.
Minimum age
6 Years
Maximum age
18 Years
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
Italy
State/province [4] 0 0
Milano

Funding & Sponsors
Primary sponsor type
Other
Name
Cooperative International Neuromuscular Research Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Muscular Dystrophy Association
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Children's National Research Institute
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Washington University School of Medicine
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Royal Children's Hospital
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Sydney Children's Hospitals Network
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Fondazione Serena Onlus - Centro Clinico NeMO Milano
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Carolinas Medical Center
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01125709
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tina T Duong, MPT
Address 0 0
Children's National Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01125709