NCT06226844 Can the BeatMove Device Help Patients With Obliterative Arterial Disease of the Lower Limbs?
| NCT ID | NCT06226844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Atheromatous |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2024-06-14 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2024-06-14 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Vascular rehabilitation for arteriopathy of the lower limbs remains little known in France, despite its good results. There are very few rehabilitation centres, and they are overcrowded and expensive. Outpatient walking rehabilitation is under-used, despite recommendations (4). One of the difficulties is getting patients to adhere to the treatment sufficiently and for a long time. According to the Fédération Française de Musicothérapie (FFM), this is a care practice based on sound or musical mediation with the aim of supporting, accompanying or re-educating a patient. Music is used as a means of expression, communication, structuring and relational analysis.The benefits of music therapy for our bodies and our behavior are numerous, including improvements in cognitive functions (attention, memory), psychomotor functions (agility, mobility, coordination) and social-emotional functions (healthymind website 10/03/2021).
Eligibility Criteria
Inclusion Criteria: * Patient with stage II arterial obliteration of the lower limbs (Leriche and Fontaine classification) with exertional claudication * Systolic Pressure Index at the toe \< 0.7 but absolute value \> 30 mmHg * Steno-occlusive lesions on arterial Doppler ultrasound examination of the lower limbs * Patient on an optimised vasculoprotective medical treatment (statin, antiplatelet agent, ACE inhibitor/ARB II) * Patient who is a beneficiary or entitled beneficiary of a health insurance scheme * Patient able to understand, write and read French * Patient who has given free and informed consent Exclusion Criteria: * Patients using walking aids (cane, wheelchair) * Amputation * Patient with a walking perimeter \< 150 m * Hearing or visual impairment * Chronic ischaemia * Trophic disorders * Orthopaedic or vascular MI surgery planned within 3 months * Major cardiovascular co-morbidities (MI \< 3 months or unstable angina) * Pregnant, breast-feeding or parturient women * Patients under court protection, guardianship or curatorship.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06226844 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atheromatous. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06226844 currently recruiting?
Yes, NCT06226844 is actively recruiting participants. Contact the research team at jeremy.laurent@chu-nimes.fr for enrollment information.
Where is the NCT06226844 trial being conducted?
This trial is being conducted at Nîmes, France.
Who is sponsoring the NCT06226844 clinical trial?
NCT06226844 is sponsored by Centre Hospitalier Universitaire de Nīmes. The trial plans to enroll 54 participants.