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Facioscapulohumeral DystrophyWANTEDNCT06600308

Walking ANalysis Interest in Persons wiTh facioscapulohumEral Muscular Dystrophies

A study testing Walk tests and ecological (real-life) assessment of walking ability in people with Facioscapulohumeral Dystrophy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Facioscapulohumeral muscular dystrophy (FSH) is one of the most common genetic myopathies in adults. It is characterised by progressive asymmetric muscular atrophy affecting the skeletal muscles of the face, upper limbs and then lower limbs, causing problems with walking, which is one of the most frequent complaints… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Facioscapulohumeral Dystrophy
What is being tested?
Walk tests and ecological (real-life) assessment of walking ability
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
3 Apr 2024to Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient :
  • Adult ;
  • Having given written consent;
  • With an established molecular genetic diagnosis of FSH;
  • Able to understand the instructions for carrying out the various tests;
  • Able to walk for at least 6 minutes, even intermittently;

Who cannot join

  • Patient :
  • Not affiliated to or not benefiting from a social security scheme;
  • With one or more cardiorespiratory contraindications to a 6-minute test;
  • With another neuro-orthopaedic history (other than FSH) that could significantly compromise walking ability;
  • With cognitive problems preventing them from performing standardised tasks;
  • Under legal protection (curatorship, guardianship).
Show all 9Show fewer
  • Who are subject to a legal protection measure;
  • Pregnant, parturient or breast-feeding woman;
  • Unable to benefit from longitudinal follow-up (D15 and M6).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Chu Dijon Bourgogne

    Dijon, 21000

    Nawale HADOUIRI, 03.80.66.90.73 ext. +33, nawale.hadouiri@chu-dijon.fr

    Recruiting

Other trials in France

About this study

Facioscapulohumeral muscular dystrophy (FSH) is one of the most common genetic myopathies in adults. It is characterised by progressive asymmetric muscular atrophy affecting the skeletal muscles of the face, upper limbs and then lower limbs, causing problems with walking, which is one of the most frequent complaints of these patients. In fact, 20% of people with FSH require a wheelchair from the age of 60. To date, scientific research into FSH has focused mainly on the molecular level, enabling potential therapeutic targets to be identified. Trials of gene therapies and other drug therapies are gradually emerging, with the aim of having a positive impact on these people\'s functional abilities, particularly walking difficulties. However, few studies have looked at the functional impact of FSH on these people, and in particular at the specific analysis of their walking ability In France, the functional assessment of FSH is carried out using a clinical reference scale called the Motor Function Measurement (MFM), the D1 sub-score of which studies items relating to standing and transfers. However, this scale does not objectively and specifically study gait disorders, and its application requires a great deal of time (at least 30 minutes) and specific training leading to certification, limiting its use in practice almost exclusively to centres of expertise and reference for neuromuscular diseases. The NeuroMuscular Score-D1 (NM-score D1), linked to the MFM D1 sub-score, is the only French scale validated in the literature for assessing the severity of gait disorders in FSH, but it is very little used in current practice because it is little known and only descriptive.

Certain functional tests of walking ability (so-called \"short-duration\" tests such as the 10-metre test at comfortable and fast speeds, the Time Up and Go test [TUG], and so-called \"long-duration\" tests such as the 6-minute test [TM6]) exist and are much simpler to use in clinical practice, do not require certification and can be carried out in a shorter time. However, to date there is no consensus on the use of these walking tests in FSH. Furthermore, their ecological capabilities (i.e. their ability to reflect what happens in real life) are not really known. In this sense, technological developments in quantified gait analysis (QGA) could help to assess locomotion disorders (of neurological, muscular or joint origin, etc.) more effectively and objectively. A more consensual use of gait tests in FSH with the use of innovative connected tools that are accessible (e.g. use of inertial units to measure spatio-temporal gait parameters during gait tests) in clinical routine would make it possible to obtain new gait analysis data to explore gait disorders more specifically and in a simple, rapid and objective manner, and thus improve and optimise the day-to-day monitoring of these patients by a large proportion of healthcare professionals.

The aim of the WANTED project is therefore to assess the value of quick and easy walking tests as part of the functional evaluation of patients with FSH by studying the correlation between the data obtained with these walking tests and that obtained with the MFM, the reference method, and also with data obtained in real-life conditions (e.g. physical activity time via actimetry).

Being tested
Walk tests, ecological (real-life) assessment of walking ability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Walk testsOther

    Performance of the following walking tests using inertial measurement units: TUG; 10 m test at a comfortable and fast speed and TM6 (according to the recommendations of the American Thoracic Society).

    At the end of each walking test, measurement of the difficulty of exertion using the Borg scale.

  • ecological (real-life) assessment of walking abilityOther

    Delivery of an actimeter, inertial units and logbook for ecological assessment (in real life) of walking ability for 7 days

Study groups in NCT06600308
Study groupRoleWhat they receive
PatientExperimentalNot described
Receives: Other: Walk tests; Other: ecological (real-life) assessment of walking ability

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average walking speed during TM6

    Measured: Through study completion, on average of 30 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start3 Apr 2024
  3. Primary completionOct 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06600308
Sponsor's protocol ID
HADOUIRI AOI 2022
Acronym
WANTED
Status last verified
Mar 2026
First submitted
13 Sep 2024
Last updated
3 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Walk tests and ecological (real-life) assessment of walking ability in people with Facioscapulohumeral Dystrophy, run by Centre Hospitalier Universitaire Dijon at 1 site 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nawale HADOUIRI (0380669073 ext. +33, nawale.hadouiri@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average walking speed during TM6 (time frame: Through study completion, on average of 30 month). 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 3 Mar 2026.

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