Can the BeatMove Device Help Patients With Obliterative Arterial Disease of the Lower Limbs?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes
About this trial
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
Qualifiers
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)
Disqualifiers
Patients using walking aids (cane, wheelchair)
Amputation
Patient with a walking perimeter < 150 m
Hearing or visual impairment
Trial design
Treatments tested in this trial
- Music therapy walking program
- Sham BeatMove
Treatment groups
54 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov