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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Music therapy walking program
DeviceIn the experimental group (PEMA BeatMove), patients will benefit from an outpatient walking training program with app-based performance monitoring, combined with music therapy (BeatMove device). The program comprises 36 walking training sessions, with 30
Sham BeatMove
DeviceAmbulatory gait training program with performance monitoring via an app, combined with sham music therapy (BeatMove device). The program includes 36 gait training sessions, each lasting 30 minutes. Patients will complete three walking sessions per week for three months.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Control group : PEMA SHAMSham comparator 1 intervention
Group B: Experimental group : PEMA BeatMoveExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group.
Maximum walking distance defined as the walking distance to the point of maximum muscular pain requiring stopping, during a treadmill test. Patients will have to do 3 walking sessions per week for a total duration of 12 weeks.
Time frame
Week 42
Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group.
Maximum walking distance defined as the walking distance to the point of maximum muscular pain requiring stopping, during a treadmill test. Patients will have to do 3 walking sessions per week for a total duration of 12 weeks.
Time frame
Week 43
Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group.
Maximum walking distance defined as the walking distance to the point of maximum muscular pain requiring stopping, during a treadmill test. Patients will have to do 3 walking sessions per week for a total duration of 12 weeks.
Time frame
Week 84
Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group.
Maximum walking distance defined as the walking distance to the point of maximum muscular pain requiring stopping, during a treadmill test. Patients will have to do 3 walking sessions per week for a total duration of 12 weeks.
Time frame
Week 8Secondary outcomes
1
Systolic pressure index at the toe at rest. Experimental group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Time frame
Day 0 at the time of consultation2
Systolic pressure index at the toe at rest. Experimental group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Time frame
Week 123
Systolic pressure index at the toe after effort. Experimental group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Time frame
Day 0 at the time of consultation4
Systolic pressure index at the toe after effort. Experimental group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Time frame
Week 12Sponsors and contacts
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Source ClinicalTrials.gov