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Completed

NCT Number: NCT04435093

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

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.

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MFM-Play

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: MFM-Play pilot

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 17, 2020
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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