Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
  • Study Primary Completion Date: January 2013

Interventions Used in this Clinical Trial

  • Device: Motriplate
    • Number of contact couples
  • Device: Motriplate
    • Number of contact couples

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: patients
    • Patients with neuromuscular disorder and controls
  • Experimental: Controls
    • healthy controls

Outcome Measures for this Clinical Trial

Primary Measures

  • Number of contact couples with the targets
    • Time Frame: Month 0, Day 60, Month 6, Month 12
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: 30 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Institut de Myologie, France
  • Provider of Information About this Clinical Study
    • Principal Investigator: Laurent Servais, M.D., Laurent Servais MD, PhD – Institut de Myologie, France

References

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.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00993161