ClinicalTrials.gg
CompletedNCT03465358MFM-tabletUpdated Aug 14, 2019

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

An observational study in Neuromuscular Diseases, sponsored by Hospices Civils de Lyon. Completed at 5 sites in France. Open to participants aged 5 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-08-14.

Sponsored by Hospices Civils de Lyon · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
5 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 84 studies in Neuromuscular Diseases with a site in France — 14 open to participants now, 17 under way, 2 of them phase 3. Neuromuscular Diseases · France.

Enrollment
12th of 36
100 · median 73
Started
2018
with 4 others
Observational
36 of 84
8 open now
Registered
43rd of 84
by date
Lead sponsor
5 of 84
Hospices Civils de Lyon

Among the 84 studies in Neuromuscular Diseases with a site in France, this one is the 12th largest by enrollment of the 36 observational ones that give a count, is one of 5 that started in 2018, is one of 36 observational ones, and was the 43rd registered.

Neuromuscular Diseases

361 studies on the registry are indexed under Neuromuscular Diseases; 97 are open to participants now.

Browse Neuromuscular Diseases studies →

Open to participants now

14 of the 84 studies in Neuromuscular Diseases with a site in France are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 70 Neuromuscular Diseases studies recruiting now, 39 (56%) set no upper age limit and 23 (33%) stop at 75 or younger; 36 take children under 18; 16 take healthy volunteers.

This study: 5 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Neuromuscular Diseases
04

Who can participate

Ages eligible
5 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with neuromuscular disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients passing their Motor Function Measure as part of another research protocol
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • OtherItems 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.

06

What researchers measure

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.

    Time frame: 1 day

07

Study locations

5 sites
  • 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
  • Centre de référence MNM Adulte Saint Etienne CHU Hôpital Nord-service neurologie
    Saint-Priest-en-Jarez, 42270, France
  • Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital de Bellevue, CHU
    Saint-Étienne, 42055, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Nov 2018, 8 months.

Of 64 non-industry observational studies under Neuromuscular Diseases, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 114. This study's 8 months is below that.

Counting every sponsor, half of 70 studies reached it within 37 months; a quarter within 12 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2018
First posted
Mar 14, 2018
StartActual
Mar 14, 2018
Primary completionActual
Nov 28, 2018
CompletionActual
Nov 28, 2018
Last update
Aug 14, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03465358
Responsible party
Sponsor
First posted
Mar 14, 2018
Start date
Mar 14, 2018
Primary completion
Nov 28, 2018
Completion
Nov 28, 2018
Last update
Aug 14, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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