Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.

NCT04435093 | Completed

• 2 other identifiers: 69HCL20_01502020-A01752-37
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

The Motor Function Measure (MFM) is a functional rating scale consisting of 32 items assessing motor functional abilities in a person with neuromuscular disease. By exploring the potential of digital technologies applied to MFM, for each item completion we want to create digital animations containing different playful and informative scenarios. This digital evolution aims to standardize assessment on the therapist's side, but also to improve acceptance of scale and patient participation. Despite the modification of the MFM completion by digital animation, the study hypothesis is that the metrological qualities of the scale are retained. Through the MFM-Play pilot study, the objective is to test 5 items of the MFM-Play scale before carrying out a validation study of the total MFM-Play.

Conditions

Neuromuscular Diseases

Keywords

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

• MFM scores item 18 to 22

  Level of agreement between the scores obtained during the classic mode and during the MFM-Play mode, completed by two different therapists.

  Day 1

Study Arms (1)

MFM completion

Other: MFM-Play

Interventions

MFM-Play OTHER

Neuromuscular patients will complete five items of the MFM (items 18 to 22) either conventionally or using the MFM-Play with 2 different therapists, on the same day. The order of the MFM type completion will be determined by randomization. Both therapists will rate items 18 to 22 blindly.

MFM completion

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will involve children with a neuromuscular disease, aged 6 to 11 years old

You may qualify if:

• Girls and boys with a neuromuscular disease
• Aged 6 to 11 years old
• With parental assent

You may not qualify if:

• Patients participating to a therapeutic trial
• Patients without compartmental capacities to participate normally to the MFM.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hospices Civils de Lyon

Bron, 69500, France

Location

CHU de Grenoble

La Tronche, 38700, France

Location

CHU Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Dominique Vincent-Genod

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: September 21, 2020
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Locations

FR (3)