Neuromuscular DisordersULENAPNCT00993161
Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder
A study testing Motriplate in people with Neuromuscular Disorders, run by Institut de Myologie, France at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 8 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Disorders
- What is being tested?
- Motriplate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Confirmed neuromuscular disorder
- Aged 8-30 years
- Written consent
- Non ambulant
Who cannot join
- Major cognitive impairment
- Inability to stay seated one hour
- Recent upper limb surgery or trauma
- Treatment by steroids initiated less than 6 months before
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Raymond Poincare
Garches, 92000
Trousseau
Paris, 75012
Institut de Myologie
Paris, 75013
Necker
Paris, 75015
About this study
Official title: Development and Evaluation of a Clinical Test in Order Quantify Muscular Function in Upper Limb of Non Ambulatory Patients With Neuromuscular Disorder
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.
- Conditions
- Neuromuscular Disorders
- Being tested
- Motriplate
- Keywords
- Neuromuscular disorders, Evaluation, Strength, Upper limb
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotriplateDevice
Number of contact couples
MotriplateDevice
Number of contact couples
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Patients with neuromuscular disorder and controls Receives: Device: Motriplate |
| Controls | Experimental | healthy controls Receives: Device: Motriplate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of contact couples with the targets
Measured: Month 0, Day 60, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Myologie, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993161
- Sponsor's protocol ID
- ULENAP
- Acronym
- ULENAP
- Status last verified
- Oct 2017
- First submitted
- 9 Oct 2009
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
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. No abstract available.
PubMed 18818076Seferian 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.
PubMed 25861036Seferian 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.
PubMed 25643053
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Clinical Test in Order Quantify Muscular Function in Upper Limb of Non Ambulatory Patients With Neuromuscular Disorder
- ClinicalTrials.gov ID
- NCT00993161
- Acronym / sponsor ID
- ULENAP / ULENAP
- Conditions
- Neuromuscular Disorders
- Keywords
- Neuromuscular disorders, Evaluation, Strength, Upper limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Institut de Myologie, FranceUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Device: MotriplatePatients with neuromuscular disorder and controls |
| Controls | Experimental | Device: Motriplatehealthy controls |
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Confirmed neuromuscular disorder
- Aged 8-30 years
- Written consent
- Non ambulant
Key exclusion criteria (4 listed)
- Major cognitive impairment
- Inability to stay seated one hour
- Recent upper limb surgery or trauma
- Treatment by steroids initiated less than 6 months before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MotriplateNumber of contact couples | Device | patients |
| MotriplateNumber of contact couples | Device | Controls |
Primary outcome
Number of contact couples with the targets
Time frame: Month 0, Day 60, Month 6, Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Background: PubMed 18818076Mercuri 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.
- Derived from this study: PubMed 25861036Seferian 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.
- Derived from this study: PubMed 25643053Seferian 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.
- website of the sponsorLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motriplate in people with Neuromuscular Disorders, run by Institut de Myologie, France at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of contact couples with the targets (time frame: Month 0, Day 60, Month 6, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00993161, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.