ULENAP: Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder

• Sponsor: Institut de Myologie, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT00993161
• Collaborator: (none)
• Enrollment: 174
• Locations: 4
• Arms: 2
• Actual Duration (Months): 40
• Patients Per Site: 43.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	Phase
Neuromuscular Disorders	Device: Motriplate; Device: Motriplate	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2010
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of contact couples with the targets [Month 0, Day 60, Month 6, Month 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 30 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Raymond Poincare	Garches		France	92000
2	Trousseau	Paris		France	75012
3	Institut de Myologie	Paris		France	75013
4	Necker	Paris		France	75015

Sponsors and Collaborators

• Institut de Myologie, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• website of the sponsor

Publications

• 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.

• Responsible Party: Institut de Myologie, France
• ClinicalTrials.gov Identifier: NCT00993161
• Other Study ID Numbers: ULENAP
• First Posted: Oct 12, 2009
• Last Update Posted: Oct 11, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Institut de Myologie, France: Neuromuscular disorders; Evaluation; Strength; Upper limb
• Additional relevant MeSH terms: Neuromuscular Diseases; Disease

Study Results

No Results Posted as of Oct 11, 2017