Can the BeatMove Device Help Patients With Obliterative Arterial Disease of the Lower Limbs?

Condition(s) studied

Investigational drug(s) / intervention(s)

Music therapy walking program: In 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: Ambulatory 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.

Study 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

Primary outcome measure(s)

• Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group. — Week 4
  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.
• Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group. — Week 4
  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.
• Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group. — Week 8
  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.
• Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group. — Week 8
  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.
• Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group. — Week 12
  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.
• Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group. — Week 12
  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.

Trial sites (1)

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