Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder

NCT ID: NCT00993161

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neuromuscular Disorders

Keywords

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Neuromuscular disorders Evaluation Strength Upper limb

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patients

Patients with neuromuscular disorder and controls

Group Type EXPERIMENTAL

Motriplate

Intervention Type DEVICE

Number of contact couples

Controls

healthy controls

Group Type EXPERIMENTAL

Motriplate

Intervention Type DEVICE

Number of contact couples

Interventions

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Motriplate

Number of contact couples

Intervention Type DEVICE

Motriplate

Number of contact couples

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut de Myologie, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Raymond Poincare

Garches, , France

Site Status

Trousseau

Paris, , France

Site Status

Institut de Myologie

Paris, , France

Site Status

Necker

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 18818076 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25861036 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25643053 (View on PubMed)

Related Links

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http://www.institut-myologie.org

website of the sponsor

Other Identifiers

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ULENAP

Identifier Type: -

Identifier Source: org_study_id