Development of Charcot Marie Tooth Disease (CMT) Pediatric Scale for Children With CMT (INC-6603)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01203085|
Recruitment Status : Recruiting
First Posted : September 16, 2010
Last Update Posted : September 13, 2017
|Condition or disease|
|Charcot Marie Tooth Disease|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Development and Validation of CMT Pediatric Scale for Children With Charcot Marie Tooth|
|Actual Study Start Date :||April 2010|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
All patients 21 years of age and under who are enrolled in the 6601 study and have undergone the pediatric scale tests.
- CMT Peds Scale Part 1: Symptoms [ Time Frame: 1 year ]The CMT Peds Scale Symptoms include foot and hand symptoms.
- CMT Peds Score Part 2: Foot and Ankle Involvement [ Time Frame: 1 year ]Foot and ankle involvement includes foot posture index, range of ankle dorsiflexion, foot drop present/absent, and whether or not difficulty heel/toe walking.
- CMT Peds Scale Part 3: Hand dexterity [ Time Frame: 1 year ]Hand dexterity involves hand dexterity testing and the nine-hole peg test.
- CMT Peds Scale Part 4: Hand strength [ Time Frame: 1 year ]Hand strength includes grip strength, thumb-index pinch, and three point pinch.
- CMT Peds Scale Part 5: Foot Strength [ Time Frame: 1 year ]Foot strength includes the strength of plantar- and dorsi-flexion, eversion, and inversion.
- CMT Peds Score Part 6: Sensation [ Time Frame: 1 year ]Sensation includes pinprick and vibration sensations.
- CMT Peds Scale Part 7: Balance [ Time Frame: 1 year ]Balance is assessed by the Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition (BOT-2).
- CMT Peds Scale Part 8: Motor Function [ Time Frame: 1 year ]Motor function assessment includes long jump, 10 meter run/walk, stair climb, stair descend, and 6 minute walk test.
- Evaluate CMT Pediatric Scale (CMT Peds Scale) in CMT natural history study [ Time Frame: 6 months to 1 year ]The sections of the CMT Peds Scale which are found to be clinically/functionally useful after one year of analysis will be carried forward for all pediatric patients every 6 months to one year.
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): NCT01203085
|Contact: Shawna M Feely, MS||319-384-6362||Shawna-Feely@uiowa.edu|
|Contact: Tiffany Grider, MS||319-384-6362||Tiffany-Grider@uiowa.edu|
|United States, California|
|Palo Alto, California, United States, 94305|
|Contact: Carly Siskind, MS, LCGC 650-721-5588 firstname.lastname@example.org|
|Principal Investigator: John Day, MD|
|United States, Connecticut|
|University of Connecticut||Recruiting|
|Hartford, Connecticut, United States, 06106|
|Contact: Gyula Acsadi, MD 860-837-7500 email@example.com|
|Principal Investigator: Gyula Acsadi, MD|
|United States, Florida|
|Nemours Children's Clinic||Recruiting|
|Orlando, Florida, United States|
|Contact: Shannon Henry, MA 407-650-7604 Shannon.Henry@nemours.org|
|Principal Investigator: Richard Finkel, MD|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Shawna M Feely, MS 319-384-6362 Shawna-Feely@uiowa.edu|
|Principal Investigator: Michael E Shy, MD|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Lauren Bogue, MS, CGC 734-647-9224 firstname.lastname@example.org|
|Principal Investigator: Sindhu Ramchandren, MS, CGC|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Janet Sowden 585-275-1267 email@example.com|
|Principal Investigator: David Herrmann, MD|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Sabrina Yum, MD 215-590-1719 YUMS@email.chop.edu|
|Principal Investigator: Sabrina Yum, MD|
|Australia, New South Wales|
|Children's Hospital of Westmead||Recruiting|
|Sydney, New South Wales, Australia, 2145|
|Contact: Natalie Gabrael +61 2 9845 1904 firstname.lastname@example.org|
|Principal Investigator: Joshua Burns, PhD|
|C. Fondazione IRCCS Istituto Neurologico Carlo Besta||Recruiting|
|Contact: Davide Pareyson, MD (+39)02-23943001 email@example.com|
|Principal Investigator: Davide Pareyson, MD|
|National Hospital of Neurology and Neurosurgery||Recruiting|
|London, England, United Kingdom, WC1N 3BG|
|Contact: Jacky Molyneaux +44 207 380 6852 firstname.lastname@example.org|
|Principal Investigator: Mary Reilly, MD|
|Dubowitz Neuromuscular Centre||Recruiting|
|London, UK, United Kingdom|
|Contact: Hinal Patel 44 02079052608 email@example.com|
|Principal Investigator: Francesco Muntoni, MD|
|Principal Investigator:||Michael E Shy, MD||University of Iowa|