Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules (MFM-Play)

Civil Hospices of Lyon

Status

Completed

Conditions

Neuromuscular Diseases

Treatments

Other: Items completion with or without a MFM-Play

Study type

Observational

Funder types

Other

Identifiers

NCT05227274

69HCL21_1088

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

2 to 60 years old

Volunteers

No Healthy Volunteers

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)