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

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ClinicalTrials.gov Identifier: NCT03465358
Recruitment Status : Completed
First Posted : March 14, 2018
Last Update Posted : August 14, 2019
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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