- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03465358
Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet (MFM-tablet)
Motor Function Measure (MFM) is a validated tool assessing the motor function of neuromuscular patients constituted of 32 items. Despite standardized Motor Function Measure (MFM) training sessions, there is still an inter-individual variability in the items' scoring procedure, depending for example on the subjectivity of the therapist.
Among the 32 items of the MFM, 3 currently require the use of a paper, and could be automated by using a digital tablet. It is the item 18 where the patient traces the edge of a Compact Disc, item 19 requiring to draw loops inside a frame and item 22 requiring to place a finger on each standardized cases. The reproducibility of these 3 items could be improved with the use of a digital tablet and the development of a software allowing to computerize the scoring procedure. The second interest is to implement directly the MFM data in the MFM base.
The hypothesis is that the difference of scoring of these 3 items between digital tablet versus paper completion is enough low to use indifferently each completion in patients with a neuromuscular disease.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bron, France, 69677
- Service de Rééducation Fonctionnelle Pédiatrique - L'Escale (Aile A1) - Hôpital Femme Mère Enfant - GHE
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Grenoble, France, 38043
- Centre de référence MNM Adulte Grenoble Consultation Maladies Neuromusculaires Adultes - CHU Michallon
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Lyon, France, 69317
- Centre de référence MNM adulte Lyon Hôpital de la Croix Rousse Bâtiment P
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Saint-Priest-en-Jarez, France, 42270
- Centre de référence MNM Adulte Saint Etienne CHU Hôpital Nord-service neurologie
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Saint-Étienne, France, 42055
- Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital de Bellevue, CHU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with a labelled neuromuscular disease
- Patients with Motor Function Measure in one of the participating services during their usual follow-up
- Patients who received the information and did not object to participating in the study or their parents for the children
Exclusion Criteria:
- Patients passing their Motor Function Measure as part of another research protocol
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison scoring between items completed using conventional material or on a digital tablet.
Time Frame: 1 day
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The comparison of scores between usual test (paper) versus digital tablet test, for the item 18, 19 and 22 of the Motor Function Measure.
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1 day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL17_0851
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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