Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600308
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Walking ANalysis Interest in Persons with FacioscapulohumEral Muscular Dystrophies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Walking ANalysis Interest in Persons with FacioscapulohumEral Muscular Dystrophies
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WANTED
Brief 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 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 people39s 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 34short-duration34 tests such as the 10-metre test at comfortable and fast speeds the Time Up and Go test TUG and so-called 34long-duration34 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 ie 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 eg 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 eg physical activity time via actimetry
Certain functional tests of walking ability so-called 34short-duration34 tests such as the 10-metre test at comfortable and fast speeds the Time Up and Go test TUG and so-called 34long-duration34 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 ie 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 eg 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 eg physical activity time via actimetry
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None