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Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study. (MFM-Play pilot)

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ClinicalTrials.gov Identifier: NCT04435093
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment
Neuromuscular Diseases Other: MFM-Play

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
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
Estimated Primary Completion Date : September 21, 2021
Estimated Study Completion Date : September 21, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MFM completion 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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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
Study Population
The study will involve children with a neuromuscular disease, aged 6 to 11 years old
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Dominique Vincent-Genod 04 72 12 95 04 ext +33 dominique.vincent-genod@chu-lyon.fr
Contact: Pascal Rippert 04 27 85 63 08 ext +33 pascal.rippert@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon Recruiting
Bron, France, 69500
Contact: Dominique Vincent-Genod    04 72 12 95 04 ext +33    dominique.vincent-genod@chu-lyon.fr   
Contact: Pascal Rippert    04 27 85 63 08 ext +33    pascal.rippert@chu-lyon.fr   
Principal Investigator: Dominique Vincent-Genod         
CHU de Grenoble Not yet recruiting
La Tronche, France, 38700
Contact: Veronique BOURG, MD    04.76.76.75.75 ext +33    vbourg@chu-grenoble.fr   
Principal Investigator: Veronique BOURG, MD         
CHU Saint Etienne Not yet recruiting
Saint-Étienne, France, 42055
Contact: Vincent GAUTHERON, MD    04.77.82.87.29 ext +33    vincent.gautheron@chu-st-etienne.fr   
Principal Investigator: Vincent GAUTHERON, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Dominique Vincent-Genod Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04435093    
Other Study ID Numbers: 69HCL20_0150
2020-A01752-37 ( Other Identifier: ID-RCB )
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Neuromuscular Diseases
Additional relevant MeSH terms:
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Neuromuscular Diseases
Nervous System Diseases