Clinical trial NCT05227274: Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules
Official title: Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases
Keywords: Motor Function Assessment
Reliability study
Patient Participation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a follow-up in a French neuromuscular reference center

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of item scoring between 2 MFM completion.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Centre de référence maladies neuromusculaires Hôpital Morvan - CHRU de Brest
city: Bron
country: France
facility: Service de Rééducation Fonctionnelle Pédiatrique - L'Escale - Hôpital Femme Mère Enfant, Hospices Civils de Lyon
city: La Tronche
country: France
facility: Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital Couple-Enfant CHU de Grenoble
city: Lille
country: France
facility: Centre de référence maladies neuromusculaires Hôpital Salengro CHU Lille
city: Lyon
country: France
facility: Consultation pluridisciplinaire MNM adulte Hôpital de la Croix Rousse, Groupement Hospitalier Nord HCL
city: Nantes
country: France
facility: ESEAN - APF France Handicap
city: Paris
country: France
facility: Consultation de pédiatrie- maladie neuromusculaire Hôpital Armand Trousseau APHP
city: Saint-Priest-en-Jarez
country: France
facility: Centre de référence MNM Adulte Saint Etienne - service neurologie CHU Hôpital Nord
city: Saint-Étienne
country: France
facility: Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital Bellevue CHU Saint Etienne
city: Toulouse
country: France
facility: Centre de référence des maladies neuromusculaires enfants Hôpital des enfants CHU de Toulouse
Study officials:
References: