Neuromuscular DiseasesMFM-PlayNCT05227274
Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules
An observational study of Neuromuscular Diseases, run by Hospices Civils de Lyon at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- Items completion with or without a MFM-Play
- How many people
- 70 participants
- Where
- 10 sitesFrance
- Study dates
- 17 Nov 2022to 3 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 years
- All sexes
- Child, Adult
Study population: Patients with a follow-up in a French neuromuscular reference center
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Centre de référence maladies neuromusculaires Hôpital Morvan - CHRU de Brest
Brest, 29200
Service de Rééducation Fonctionnelle Pédiatrique - L'Escale - Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, 69500
Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital Couple-Enfant CHU de Grenoble
La Tronche, 38700
Centre de référence maladies neuromusculaires Hôpital Salengro CHU Lille
Lille, 59000
Consultation pluridisciplinaire MNM adulte Hôpital de la Croix Rousse, Groupement Hospitalier Nord HCL
Lyon, 69004
ESEAN - APF France Handicap
Nantes, 44200
Consultation de pédiatrie- maladie neuromusculaire Hôpital Armand Trousseau APHP
Paris, 75012
Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital Bellevue CHU Saint Etienne
Saint-Etienne, 42000
Centre de référence MNM Adulte Saint Etienne - service neurologie CHU Hôpital Nord
Saint-Priest-en-Jarez, 42270
Centre de référence des maladies neuromusculaires enfants Hôpital des enfants CHU de Toulouse
Toulouse, 31059
About this study
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.
Read more
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.
- Conditions
- Neuromuscular Diseases
- Being tested
- Items completion with or without a MFM-Play
- Keywords
- Motor Function Assessment, Reliability study, Patient Participation
- Medical subject headings
- Neuromuscular Diseases, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Items completion with or without a MFM-PlayOther
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
| Study group | Role | What they receive |
|---|---|---|
| MFM-Play | Neuromuscular disease patients completed MFM using MFM-Play Receives: Other: Items completion with or without a MFM-Play |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraclass correlation coefficient (ICC) for MFM total score and D1-D3 subscores
ICC for MFM total score and D1-D3 subscores between the two MFM Play assessments performed by different therapists ICCs for MFM total score and D1-D3 subscores between MFM Play and conventional MFM
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start17 Nov 2022
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227274
- Sponsor's protocol ID
- 69HCL21_1088
- Acronym
- MFM-Play
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vincent-Genod D, Verroul M, Rippert P, Tachibana S, Vuillerot C; MFM-Play Study Group. Barriers and levers to using an app for motor function assessment by therapists in hospitals: A qualitative study of the MFM-Play app. PLoS One. 2026 Jul 31;21(7):e0352856. doi: 10.1371/journal.pone.0352856. eCollection 2026.
PubMed 42536628
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules
- ClinicalTrials.gov ID
- NCT05227274
- Acronym / sponsor ID
- MFM-Play / 69HCL21_1088
- Conditions
- Neuromuscular Diseases
- Keywords
- Motor Function Assessment, Reliability study, Patient Participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MFM-Play | – | Other: Items completion with or without a MFM-PlayNeuromuscular disease patients completed MFM using MFM-Play |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients with a follow-up in a French neuromuscular reference center
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Items completion with or without a MFM-PlayPatients 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 | Other | MFM-Play |
Primary outcome
Intraclass correlation coefficient (ICC) for MFM total score and D1-D3 subscores
Time frame: 3 months
ICC for MFM total score and D1-D3 subscores between the two MFM Play assessments performed by different therapists ICCs for MFM total score and D1-D3 subscores between MFM Play and conventional MFM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Results publication: PubMed 42536628Vincent-Genod D, Verroul M, Rippert P, Tachibana S, Vuillerot C; MFM-Play Study Group. Barriers and levers to using an app for motor function assessment by therapists in hospitals: A qualitative study of the MFM-Play app. PLoS One. 2026 Jul 31;21(7):e0352856. doi: 10.1371/journal.pone.0352856. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases, run by Hospices Civils de Lyon at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraclass correlation coefficient (ICC) for MFM total score and D1-D3 subscores (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05227274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.