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
  Purpose

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.


Condition Intervention
Neuromuscular Disorders
Device: Motriplate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Development and Evaluation of a Clinical Test in Order Quantify Muscular Function in Upper Limb of Non Ambulatory Patients With Neuromuscular Disorder

Resource links provided by NLM:


Further study details as provided by Institut de Myologie, France:

Primary Outcome Measures:
  • Number of contact couples with the targets [ Time Frame: Month 0, Day 60, Month 6, Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients
Patients with neuromuscular disorder and controls
Device: Motriplate
Number of contact couples
Experimental: Controls
healthy controls
Device: Motriplate
Number of contact couples

  Eligibility

Ages Eligible for Study:   8 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993161

Locations
France
Hôpital Raymond Poincare Recruiting
Garches, France, 92000
Contact: Susana Quijano, Md       susana.quijano-roy@rpc.aphp.fr   
Institut de Myologie Recruiting
Paris, France, 75013
Contact: Laurent Servais, Md, PhD    33622592243    l.servais@institut-myologie.org   
Trousseau Recruiting
Paris, France, 75012
Contact: Michele Mayer       michele.mayer@trs.aphp.fr   
Necker Recruiting
Paris, France, 75015
Contact: Isabelle Desguerre, MD    33144495836    isabelle.desguerre@nck.aphp.fr   
Sponsors and Collaborators
Institut de Myologie, France
  More Information

Additional Information:
Publications:
Responsible Party: Laurent Servais, M.D., Laurent Servais MD, PhD, Institut de Myologie, France
ClinicalTrials.gov Identifier: NCT00993161     History of Changes
Other Study ID Numbers: 2009-A00600-57
Study First Received: October 9, 2009
Last Updated: November 16, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut de Myologie, France:
Neuromuscular disorders
Evaluation
Strength
Upper limb

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 16, 2014