Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder

Neuromuscular Disorders Clinical Trial

— ULENAP  

Official title:

Development and Evaluation of a Clinical Test in Order Quantify Muscular Function in Upper Limb of Non Ambulatory Patients With Neuromuscular Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993161
• Other study ID #: ULENAP
• Status: Completed
• Phase: N/A
• First received: October 9, 2009
• Last updated: October 10, 2017
• Start date: January 2010
• Est. completion date: May 2013

Study information

• Verified date: October 2017
• Source: Institut de Myologie, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Neuromuscular Diseases
• Neuromuscular Disorders

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Raymond Poincare	Garches
France	Institut de Myologie	Paris
France	Necker	Paris
France	Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Myologie, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. doi: 10.1016/j.nmd.2008.07.003. Epub 2008 Sep 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of contact couples with the targets		Month 0, Day 60, Month 6, Month 12

External Links

•   website of the sponsor