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

Neuromuscular Diseases Clinical Trial

— MFM-tablet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465358
• Other study ID #: 69HCL17_0851
• Status: Completed
• Start date: March 14, 2018
• Est. completion date: November 28, 2018

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Service de Rééducation Fonctionnelle Pédiatrique - L'Escale (Aile A1) - Hôpital Femme Mère Enfant - GHE	Bron
France	Centre de référence MNM Adulte Grenoble Consultation Maladies Neuromusculaires Adultes - CHU Michallon	Grenoble
France	Centre de référence MNM adulte Lyon Hôpital de la Croix Rousse Bâtiment P	Lyon
France	Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital de Bellevue, CHU	Saint-Étienne
France	Centre de référence MNM Adulte Saint Etienne CHU Hôpital Nord-service neurologie	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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