Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules

Neuromuscular Diseases Clinical Trial

— MFM-Play  

Official title:

Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05227274
• Other study ID #: 69HCL21_1088
• Status: Not yet recruiting
• Start date: April 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2022
• Source: Hospices Civils de Lyon
• Contact: Dominique VINCENT-GENOD
• Phone: 04.72.12.95.04
• Email: dominique.vincent-genod[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 2 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

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

Country	Name	City	State
France	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	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-Étienne
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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of item scoring between 2 MFM completion.	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.	3 months