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
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Tracking Information | |||||
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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 |
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.
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
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. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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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. |
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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. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Current Responsible Party | Hospices Civils de Lyon | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Hospices Civils de Lyon | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Hospices Civils de Lyon | ||||
Verification Date | August 2019 |