Neuromuscular DiseasesMFM-Play pilotNCT04435093
Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.
An observational study of Neuromuscular Diseases, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- MFM-Play
- How many people
- 19 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Sep 2020to 4 Mar 2021
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: The study will involve children with a neuromuscular disease, aged 6 to 11 years old
Who may be able to join
- Girls and boys with a neuromuscular disease
- Aged 6 to 11 years old
- With parental assent
Who cannot join
- Patients participating to a therapeutic trial
- Patients without compartmental capacities to participate normally to the MFM.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hospices Civils de Lyon
Bron, 69500
CHU de Grenoble
La Tronche, 38700
CHU Saint Etienne
Saint-Etienne, 42055
About this study
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.
Read more
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
- Being tested
- MFM-Play
- Keywords
- Neuromuscular Diseases
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MFM-PlayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MFM completion | Not described Receives: Other: MFM-Play |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start21 Sep 2020
- Primary completion4 Mar 2021
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Vincent-Genod, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435093
- Sponsor's protocol ID
- 69HCL20_0150
- Other IDs
- 2020-A01752-37
- Acronym
- MFM-Play pilot
- Status last verified
- May 2021
- First submitted
- 15 Jun 2020
- Last updated
- 28 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.
- ClinicalTrials.gov ID
- NCT04435093
- Acronym / sponsor ID
- MFM-Play pilot / 69HCL20_0150
- Conditions
- Neuromuscular Diseases
- Keywords
- Neuromuscular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 17 Jun 2020 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MFM completion | – | Other: MFM-Play |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study will involve children with a neuromuscular disease, aged 6 to 11 years old
Key inclusion criteria (3 listed)
- Girls and boys with a neuromuscular disease
- Aged 6 to 11 years old
- With parental assent
Key exclusion criteria (2 listed)
- Patients participating to a therapeutic trial
- Patients without compartmental capacities to participate normally to the MFM.
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 |
|---|---|---|
| MFM-PlayNeuromuscular 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. | Other | MFM completion |
Primary outcome
MFM scores item 18 to 22
Time frame: Day 1
Level of agreement between the scores obtained during the classic mode and during the MFM-Play mode, completed by two different therapists.
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 28 May 2021.
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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.
Dominique Vincent-Genod principal investigator
Hospices Civils de Lyon
3 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 3 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 2 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 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
MFM scores item 18 to 22 (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2021.