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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04435093
Other study ID # 69HCL20_0150
Secondary ID 2020-A01752-37
Status Completed
Phase
First received
Last updated
Start date September 21, 2020
Est. completion date March 4, 2021

Study information

Verified date May 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date March 4, 2021
Est. primary completion date March 4, 2021
Accepts healthy volunteers No
Gender All
Age group 6 Years to 11 Years
Eligibility Inclusion Criteria: - Girls and boys with a neuromuscular disease - Aged 6 to 11 years old - With parental assent Exclusion Criteria: - Patients participating to a therapeutic trial - Patients without compartmental capacities to participate normally to the MFM.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MFM-Play
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.

Locations

Country Name City State
France Hospices Civils de Lyon Bron
France CHU de Grenoble La Tronche
France CHU Saint Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary MFM scores item 18 to 22 Level of agreement between the scores obtained during the classic mode and during the MFM-Play mode, completed by two different therapists. Day 1
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