Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet
MFM-tablet
1 other identifier
observational
100
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2018
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2018
CompletedFirst Posted
Study publicly available on registry
March 14, 2018
CompletedStudy Start
First participant enrolled
March 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2018
CompletedAugust 14, 2019
August 1, 2019
9 months
March 8, 2018
August 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison scoring between items completed using conventional material or on a digital tablet.
The comparison of scores between usual test (paper) versus digital tablet test, for the item 18, 19 and 22 of the Motor Function Measure.
1 day
Interventions
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.
Eligibility Criteria
Patients with neuromuscular disease
You may qualify if:
- 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
You may not qualify if:
- Patients passing their Motor Function Measure as part of another research protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Service de Rééducation Fonctionnelle Pédiatrique - L'Escale (Aile A1) - Hôpital Femme Mère Enfant - GHE
Bron, 69677, France
Centre de référence MNM Adulte Grenoble Consultation Maladies Neuromusculaires Adultes - CHU Michallon
Grenoble, 38043, France
Centre de référence MNM adulte Lyon Hôpital de la Croix Rousse Bâtiment P
Lyon, 69317, France
Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital de Bellevue, CHU
Saint-Etienne, 42055, France
Centre de référence MNM Adulte Saint Etienne CHU Hôpital Nord-service neurologie
Saint-Priest-en-Jarez, 42270, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2018
First Posted
March 14, 2018
Study Start
March 14, 2018
Primary Completion
November 28, 2018
Study Completion
November 28, 2018
Last Updated
August 14, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share