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Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet (MFM-tablet)

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ClinicalTrials.gov Identifier: NCT03465358
Recruitment Status : Completed
First Posted : March 14, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Neuromuscular Diseases Other: Items completion

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet
Actual Study Start Date : March 14, 2018
Actual Primary Completion Date : November 28, 2018
Actual Study Completion Date : November 28, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Items completion

    Patients will complete his Motor Function Measure in the usual way, except items 18, 19 and 22 which will be completed twice: once using conventional material and once on a digital tablet.

    The order of completion between conventional material or digital tablet will be allocate randomly.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison scoring between items completed using conventional material or on a digital tablet. [ Time Frame: 1 day ]
    The comparison of scores between usual test (paper) versus digital tablet test, for the item 18, 19 and 22 of the Motor Function Measure.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with neuromuscular disease
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465358


Locations
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France
Service de Rééducation Fonctionnelle Pédiatrique - L'Escale (Aile A1) - Hôpital Femme Mère Enfant - GHE
Bron, France, 69677
Centre de référence MNM Adulte Grenoble Consultation Maladies Neuromusculaires Adultes - CHU Michallon
Grenoble, France, 38043
Centre de référence MNM adulte Lyon Hôpital de la Croix Rousse Bâtiment P
Lyon, France, 69317
Centre de référence MNM Adulte Saint Etienne CHU Hôpital Nord-service neurologie
Saint-Priest-en-Jarez, France, 42270
Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital de Bellevue, CHU
Saint-Étienne, France, 42055
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03465358    
Other Study ID Numbers: 69HCL17_0851
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Nervous System Diseases