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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00993161
Recruitment Status : Completed
First Posted : October 12, 2009
Last Update Posted : October 11, 2017
Information provided by (Responsible Party):
Institut de Myologie, France

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.

Condition or disease Intervention/treatment
Neuromuscular Disorders Device: Motriplate

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development and Evaluation of a Clinical Test in Order Quantify Muscular Function in Upper Limb of Non Ambulatory Patients With Neuromuscular Disorder
Actual Study Start Date : January 2010
Primary Completion Date : April 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: patients
Patients with neuromuscular disorder and controls
Device: Motriplate
Number of contact couples
Experimental: Controls
healthy controls
Device: Motriplate
Number of contact couples

Primary Outcome Measures :
  1. Number of contact couples with the targets [ Time Frame: Month 0, Day 60, Month 6, Month 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993161

Hôpital Raymond Poincare
Garches, France, 92000
Paris, France, 75012
Institut de Myologie
Paris, France, 75013
Paris, France, 75015
Sponsors and Collaborators
Institut de Myologie, France

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut de Myologie, France
ClinicalTrials.gov Identifier: NCT00993161     History of Changes
Other Study ID Numbers: ULENAP
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Neuromuscular Diseases
Pathologic Processes
Nervous System Diseases