NCT01125709

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

January 11, 2013

Status Verified

January 1, 2013

Enrollment Period

5 months

First QC Date

May 17, 2010

Last Update Submit

January 10, 2013

Conditions

Duchenne Muscular Dystrophy

Keywords

Neuromuscular diseaseDuchenneMuscular DystrophyDMDStrength assessmentCINRG Quantitative Measurement SystemCQMSHand Held MyometryHHM

Outcome Measures

Primary Outcomes (1)

  • 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.

    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).

    two-day visit

Eligibility Criteria

Age6 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Participants will be selected from participating CINRG institution's neuromuscular clinics.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Washington University - St. Louis

St Louis, Missouri, 63110, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28207, United States

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Centro Clinico Nemo

Milan, 20162, Italy

Location

Related Links

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneNeuromuscular DiseasesMuscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Tina T Duong, MPT

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 18, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

January 11, 2013

Record last verified: 2013-01

Locations

US(3)AU(1)IT(1)