Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder (ULENAP)

This study is currently recruiting participants.

Verified November 2011 by Institut de Myologie, France

Sponsor:

Information provided by (Responsible Party):

Laurent Servais, M.D., Institut de Myologie, France

ClinicalTrials.gov Identifier:

NCT00993161

First received: October 9, 2009

Last updated: November 16, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 9, 2009
Last Updated Date	November 16, 2011
Start Date ^ICMJE	January 2010
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 9, 2009)	Number of contact couples with the targets [ Time Frame: Month 0, Day 60, Month 6, Month 12 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00993161 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder
Official Title ^ICMJE	Development and Evaluation of a Clinical Test in Order Quantify Muscular Function in Upper Limb of Non Ambulatory Patients With Neuromuscular Disorder
Brief Summary	The aim of this study is to evaluate different devices to quantify upper limb function (Motriplate) and strength (Myogrip, Myopinch) in non-ambulatory patients with neuromuscular disorder. Motriplate measures the ability of the patient to reproduce a repetitive movement of the wrist to push two 5cm*5cm targets during 30 seconds. One hundred patients aged 8-30 years and 60 controls will be evaluated during twelve months (M0, M6 and M12) with theses new tools, and results will be compared to other testing, such as wrist, grip and pinch strength, taping, MFM measurement, and self evaluation of hand ability.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label
Condition ^ICMJE	Neuromuscular Disorders
Intervention ^ICMJE	Device: Motriplate Number of contact couples
Study Arm (s)	Experimental: patients Patients with neuromuscular disorder and controls Intervention: Device: Motriplate Experimental: Controls healthy controls Intervention: Device: Motriplate
Publications *	Mercuri E, Mayhew A, Muntoni F, Messina S, Straub V, Van Ommen GJ, Voit T, Bertini E, Bushby K; TREAT-NMD Neuromuscular Network. Towards harmonisation of outcome measures for DMD and SMA within TREAT-NMD; report of three expert workshops: TREAT-NMD/ENMC workshop on outcome measures, 12th--13th May 2007, Naarden, The Netherlands; TREAT-NMD workshop on outcome measures in experimental trials for DMD, 30th June--1st July 2007, Naarden, The Netherlands; conjoint Institute of Myology TREAT-NMD meeting on physical activity monitoring in neuromuscular disorders, 11th July 2007, Paris, France. Neuromuscul Disord. 2008 Nov;18(11):894-903. Epub 2008 Sep 24. No abstract available.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	160
Estimated Completion Date	January 2013
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Confirmed neuromuscular disorder Aged 8-30 years Written consent Non ambulant Exclusion Criteria Major cognitive impairment Inability to stay seated one hour Recent upper limb surgery or trauma Treatment by steroids initiated less than 6 months before
Gender	Both
Ages	8 Years to 30 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00993161
Other Study ID Numbers ^ICMJE	2009-A00600-57
Has Data Monitoring Committee	No
Responsible Party	Laurent Servais, M.D., Institut de Myologie, France
Study Sponsor ^ICMJE	Institut de Myologie, France
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Institut de Myologie, France
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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