Skip to main content
OpenTrials
Completed

NCT Number: NCT05227274

Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules

Neuromuscular diseases include more than 200 rare disorders affecting muscles or the nervous system. Functional scales assessing motor function are tools allowing to measure the evolution of motor impairment of patients with a neuromuscular disease. They are frequently used as main outcome measures in clinical trials which are currently in full development thanks to advances in genetic and drug researches.

Among the available scales, the Motor Function Measure (MFM), a scale consisting of 32 items, had shown good metrological properties in terms of validity, reliability and sensitivity to change, regardless of the diagnosis and extent of motor impairment.

By exploring the potential of digital technologies applied to MFM, investigators created a completion module composed of animations with different playful and informative scenarios displayed on a digital tablet.

The main purpose of this project is to conduct a multicentre study to assess reliabilities of the MFM completed using the MFM-Play.

Expected benefits of this project are to improve the experience and the participation of the children to who is often imposed multiple assessments during the numerous follow-up visits of clinical trials, while maintaining good metrological properties of the MFM.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de référence maladies neuromusculaires Hôpital Morvan - CHRU de Brest, Brest, France

Loading trial locations.

Who can participate

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

Inclusion criteria

  • Patients with a neuromuscular disease confirmed by the clinic, electroneuromyography (ENMG), biology, muscular biopsy, or genetic
  • aged ≥ 2 yo and ≤ 60 yo
  • having been informed and not objecting to participating in the study (information and non-opposition of parents/holders of parental authority for minor patients)

Exclusion criteria

  • participating in other interventional research with an exclusion period that is still ongoing or that may interfere with the results of this study
  • having had surgery or illness impacting their motor function within the last 6 months
  • having understanding and/or behavioral deficiencies preventing rigorous assessment
  • Patient placed under legal protection (this includes guardianship, curatorship and safeguard of justice)

Treatment and study plan

Items completion with or without a MFM-Play

Other

Patients will completed 3 MFM during the follow-up, two times using the MFM-Play, and one without the MFM-Play Delay between each MFM completion will be 1 month ± 15 days

Primary outcomes

  1. Comparison of item scoring between 2 MFM completion.

    Time frame: 3 months

    Level of agreement between MFM item scores reported by physiotherapists during 2 different MFM completion using the MFM-Play.

    Level of agreement between MFM item scores reported by a same physiotherapist during a MFM completion using the MFM-Play and a MFM completed conventionally.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: MFM-Play

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2022
Registry last updated
Nov 4, 2024

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.

Published trials that share one or more normalized conditions with this study.