Development of Charcot Marie Tooth Disease (CMT) Pediatric Scale for Children With CMT (INC-6603)
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|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.
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 email@example.com|
|Principal Investigator: John Day, MD|
|United States, Connecticut|
|University of Connecticut||Recruiting|
|Hartford, Connecticut, United States, 06106|
|Contact: Gyula Acsadi, MD 860-837-7500 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Joshua Burns, PhD|
|C. Fondazione IRCCS Istituto Neurologico Carlo Besta||Recruiting|
|Contact: Davide Pareyson, MD (+39)02-23943001 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Mary Reilly, MD|
|Dubowitz Neuromuscular Centre||Recruiting|
|London, UK, United Kingdom|
|Contact: Hinal Patel 44 02079052608 firstname.lastname@example.org|
|Principal Investigator: Francesco Muntoni, MD|
|Principal Investigator:||Michael E Shy, MD||University of Iowa|