NCT03465358

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 14, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2018

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

March 8, 2018

Last Update Submit

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

Age5 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Centre de référence MNM Adulte Grenoble Consultation Maladies Neuromusculaires Adultes - CHU Michallon

Grenoble, 38043, France

Location

Centre de référence MNM adulte Lyon Hôpital de la Croix Rousse Bâtiment P

Lyon, 69317, France

Location

Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital de Bellevue, CHU

Saint-Etienne, 42055, France

Location

Centre de référence MNM Adulte Saint Etienne CHU Hôpital Nord-service neurologie

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

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

Locations