Reliability Study of a Motor Function Measure Digitalized... | NCT05227274

Studies
Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules

NCT05227274

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Nov 4, 2024Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Neuromuscular Diseases

Interventions

Items completion with or without a MFM-Play

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2022Actual

Primary Completion Date

Jul 3, 2024Actual

Completion Date

Jul 3, 2024Actual

First Submitted Date

Jan 26, 2022

First Submission Date that Met QC Criteria

Jan 26, 2022

First Posted Date

Feb 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2024

Last Update Posted Date

Nov 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MFM-Play		Neuromuscular disease patients completed MFM using MFM-Play	Other: Items completion with or without a MFM-Play

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Items completion with or without a MFM-Play	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Patients with a follow-up in a French neuromuscular reference center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de référence maladies neuromusculaires Hôpital Morvan - CHRU de Brest		Brest		29200	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009468	Neuromuscular Diseases
D010358	Patient Participation

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior

Browse Leaves

Not provided

Browse Branches

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