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

NCT ID: NCT04435093

Last Updated: 2021-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-21

Study Completion Date

2021-03-04

Brief Summary

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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.

Detailed Description

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Conditions

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Neuromuscular Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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MFM completion

MFM-Play

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominique Vincent-Genod

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon

Bron, , France

Site Status

CHU de Grenoble

La Tronche, , France

Site Status

CHU Saint Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2020-A01752-37

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL20_0150

Identifier Type: -

Identifier Source: org_study_id

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