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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Institut de Myologie, France.
Recruitment status was  Recruiting
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

October 9, 2009
November 16, 2011
January 2010
January 2013   (final data collection date for primary outcome measure)
Number of contact couples with the targets [ Time Frame: Month 0, Day 60, Month 6, Month 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00993161 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder
Development and Evaluation of a Clinical Test in Order Quantify Muscular Function in Upper Limb of Non Ambulatory Patients With Neuromuscular Disorder

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Neuromuscular Disorders
Device: Motriplate
Number of contact couples
  • Experimental: patients
    Patients with neuromuscular disorder and controls
    Intervention: Device: Motriplate
  • Experimental: Controls
    healthy controls
    Intervention: Device: Motriplate
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.
 
Recruiting
160
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
8 Years to 30 Years
Yes
France
 
NCT00993161
2009-A00600-57
No
Laurent Servais, M.D., Institut de Myologie, France
Institut de Myologie, France
Not Provided
Not Provided
Institut de Myologie, France
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP