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

Primary Purpose

Neuromuscular Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Motriplate
Motriplate
Sponsored by
Institut de Myologie, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neuromuscular Disorders focused on measuring Neuromuscular disorders, Evaluation, Strength, Upper limb

Eligibility Criteria

8 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital Raymond Poincare
  • Trousseau
  • Institut de Myologie
  • Necker

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patients

Controls

Arm Description

Patients with neuromuscular disorder and controls

healthy controls

Outcomes

Primary Outcome Measures

Number of contact couples with the targets

Secondary Outcome Measures

Full Information

First Posted
October 9, 2009
Last Updated
October 10, 2017
Sponsor
Institut de Myologie, France
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1. Study Identification

Unique Protocol Identification Number
NCT00993161
Brief Title
Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Myologie, France

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Disorders
Keywords
Neuromuscular disorders, Evaluation, Strength, Upper limb

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
Patients with neuromuscular disorder and controls
Arm Title
Controls
Arm Type
Experimental
Arm Description
healthy controls
Intervention Type
Device
Intervention Name(s)
Motriplate
Intervention Description
Number of contact couples
Intervention Type
Device
Intervention Name(s)
Motriplate
Intervention Description
Number of contact couples
Primary Outcome Measure Information:
Title
Number of contact couples with the targets
Time Frame
Month 0, Day 60, Month 6, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Hôpital Raymond Poincare
City
Garches
ZIP/Postal Code
92000
Country
France
Facility Name
Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Institut de Myologie
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Necker
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18818076
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
25861036
Citation
Seferian AM, Moraux A, Canal A, Decostre V, Diebate O, Le Moing AG, Gidaro T, Deconinck N, Van Parys F, Vereecke W, Wittevrongel S, Annoussamy M, Mayer M, Maincent K, Cuisset JM, Tiffreau V, Denis S, Jousten V, Quijano-Roy S, Voit T, Hogrel JY, Servais L. Upper limb evaluation and one-year follow up of non-ambulant patients with spinal muscular atrophy: an observational multicenter trial. PLoS One. 2015 Apr 10;10(4):e0121799. doi: 10.1371/journal.pone.0121799. eCollection 2015.
Results Reference
derived
PubMed Identifier
25643053
Citation
Seferian AM, Moraux A, Annoussamy M, Canal A, Decostre V, Diebate O, Le Moing AG, Gidaro T, Deconinck N, Van Parys F, Vereecke W, Wittevrongel S, Mayer M, Maincent K, Desguerre I, Themar-Noel C, Cuisset JM, Tiffreau V, Denis S, Jousten V, Quijano-Roy S, Voit T, Hogrel JY, Servais L. Upper limb strength and function changes during a one-year follow-up in non-ambulant patients with Duchenne Muscular Dystrophy: an observational multicenter trial. PLoS One. 2015 Feb 2;10(2):e0113999. doi: 10.1371/journal.pone.0113999. eCollection 2015.
Results Reference
derived
Links:
URL
http://www.institut-myologie.org
Description
website of the sponsor

Learn more about this trial

Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder

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