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COMPLETED
NCT05227274

Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

2 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2022-11-17

Completion Date

2024-07-03

Last Updated

2026-09-14

Healthy Volunteers

Not specified

Interventions

OTHER

Items completion with or without a MFM-Play

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

Locations (10)

Centre de référence maladies neuromusculaires Hôpital Morvan - CHRU de Brest

Brest, France

Service de Rééducation Fonctionnelle Pédiatrique - L'Escale - Hôpital Femme Mère Enfant, Hospices Civils de Lyon

Bron, France

Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital Couple-Enfant CHU de Grenoble

La Tronche, France

Centre de référence maladies neuromusculaires Hôpital Salengro CHU Lille

Lille, France

Consultation pluridisciplinaire MNM adulte Hôpital de la Croix Rousse, Groupement Hospitalier Nord HCL

Lyon, France

ESEAN - APF France Handicap

Nantes, France

Consultation de pédiatrie- maladie neuromusculaire Hôpital Armand Trousseau APHP

Paris, France

Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital Bellevue CHU Saint Etienne

Saint-Etienne, France

Centre de référence MNM Adulte Saint Etienne - service neurologie CHU Hôpital Nord

Saint-Priest-en-Jarez, France

Centre de référence des maladies neuromusculaires enfants Hôpital des enfants CHU de Toulouse

Toulouse, France