Comparative Study of Clinical Endpoint in DMD: Handheld Myometry (HHM) Versus CINRG Quantitative Measurement System (CQMS)

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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Key information

Conditions

Duchenne Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

6 year–18 year

Sex eligibility

Male

Study type

Observational

Primary location

Royal Children's Hospital, Parkville, Victoria, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Participants should meet the following criteria:

Confirmed clinical and molecular diagnosis of DMD
6- 18 years of age
Ability to follow 2 step instructions
Ability to transfer to and from the wheelchair-mat with moderate assistance defined as no greater than 75% assistance.
Signed informed consent of parental or legal guardian(s) is required for participants. Assent from children 7-18 years old may also required.

Exclusion criteria

Participants must confirm:

No Surgical procedures were performed ≤ 8 weeks before study procedures.
No musculoskeletal injuries were experienced ≤ 8 weeks before study procedures.
Investigator assessment that patient or parent/legal guardian are not willing or able to comply with study procedures.

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Cooperative International Neuromuscular Research Group

Network

Collaborators

Carolinas Medical Center
Children's National Research Institute
Fondazione Serena Onlus - Centro Clinico NeMO Milano
Muscular Dystrophy Association
Royal Children's Hospital
Sydney Children's Hospitals Network
Washington University School of Medicine

Registry information

Official study title

Comparative Study of Clinical Endpoint in DMD: HHM vs. CQMS

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: May 18, 2010
Registry last updated: Jan 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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