Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study. (MFM-Play pilot)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04435093|
Recruitment Status : Completed
First Posted : June 17, 2020
Last Update Posted : May 28, 2021
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The Motor Function Measure (MFM) is a functional rating scale consisting of 32 items assessing motor functional abilities in a person with neuromuscular disease.
By exploring the potential of digital technologies applied to MFM, for each item completion we want to create digital animations containing different playful and informative scenarios. This digital evolution aims to standardize assessment on the therapist's side, but also to improve acceptance of scale and patient participation.
Despite the modification of the MFM completion by digital animation, the study hypothesis is that the metrological qualities of the scale are retained.
Through the MFM-Play pilot study, the objective is to test 5 items of the MFM-Play scale before carrying out a validation study of the total MFM-Play.
|Condition or disease||Intervention/treatment|
|Neuromuscular Diseases||Other: MFM-Play|
|Study Type :||Observational|
|Actual Enrollment :||19 participants|
|Official Title:||Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.|
|Actual Study Start Date :||September 21, 2020|
|Actual Primary Completion Date :||March 4, 2021|
|Actual Study Completion Date :||March 4, 2021|
Neuromuscular patients will complete five items of the MFM (items 18 to 22) either conventionally or using the MFM-Play with 2 different therapists, on the same day. The order of the MFM type completion will be determined by randomization. Both therapists will rate items 18 to 22 blindly.
- MFM scores item 18 to 22 [ Time Frame: Day 1 ]Level of agreement between the scores obtained during the classic mode and during the MFM-Play mode, completed by two different therapists.
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|Ages Eligible for Study:||6 Years to 11 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Girls and boys with a neuromuscular disease
- Aged 6 to 11 years old
- With parental assent
- Patients participating to a therapeutic trial
- Patients without compartmental capacities to participate normally to the MFM.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435093
|Hospices Civils de Lyon|
|Bron, France, 69500|
|CHU de Grenoble|
|La Tronche, France, 38700|
|CHU Saint Etienne|
|Saint-Étienne, France, 42055|
|Principal Investigator:||Dominique Vincent-Genod||Hospices Civils de Lyon|
|Responsible Party:||Hospices Civils de Lyon|
|Other Study ID Numbers:||
2020-A01752-37 ( Other Identifier: ID-RCB )
|First Posted:||June 17, 2020 Key Record Dates|
|Last Update Posted:||May 28, 2021|
|Last Verified:||May 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Nervous System Diseases