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

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

Tracking Information

• First Submitted Date: March 8, 2018
• First Posted Date: March 14, 2018
• Last Update Posted Date: August 14, 2019
• Actual Study Start Date: March 14, 2018
• Actual Primary Completion Date: November 28, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2018)

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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03465358 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with neuromuscular disease
• Condition: 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.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 8, 2018): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 28, 2018
• Actual Primary Completion Date: November 28, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03465358
• Other Study ID Numbers: 69HCL17_0851
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Hospices Civils de Lyon
• Study Sponsor: Hospices Civils de Lyon
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hospices Civils de Lyon
• Verification Date: August 2019