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

Official title

Evaluation of the Value of Music Therapy (BeatMove Device) in a 3-month Outpatient Walking Rehabilitation Programme for Patients With Obliterative Arterial Disease of the Lower Limbs (AOMI) at the Stress Ischaemia Stage.

Overview

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).

Detailed description

Atheromatous obliterative arterial disease of the lower limbs at the stage of exertional ischaemia is characterised by intermittent claudication, defined as pain in the lower limbs on walking, forcing the patient to stop for a few minutes after a distance that varies according to the severity of the arterial damage. Physical exercise, and walking training in particular, plays a fundamental role in the management of patients with arterial disease. The beneficial effects of exercise are well known. A recent Cochrane review showed that exercise improves pain-free walking distance and maximum walking distance by at least 100% in patients with arterial hypertension (2). Exercise also significantly reduces total and cardiovascular mortality (3).

In the case of intermittent claudication, medical treatment with supervised vascular rehabilitation is recommended in rehabilitation centres or on an outpatient basis. 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.

Musico therapy : 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).

Interventions

• Device 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
• Device 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.

Primary outcome measures

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

Secondary outcome measures (12)

• Systolic pressure index at the toe at rest. Experimental group [Time frame: Day 0 at the time of consultation]
• Systolic pressure index at the toe at rest. Experimental group [Time frame: Week 12]
• Systolic pressure index at the toe after effort. Experimental group [Time frame: Day 0 at the time of consultation]
• Systolic pressure index at the toe after effort. Experimental group [Time frame: Week 12]
• Systolic pressure index at the toe at rest. Sham group [Time frame: Day 0 at the time of consultation]
• Systolic pressure index at the toe at rest. Sham group [Time frame: Week 12]
• Systolic pressure index at the toe after effort. Sham group [Time frame: Day 0 at the time of consultation]
• Systolic pressure index at the toe after effort. Sham group [Time frame: Week 12]
• Results of the EQ-5D-5L questionnaire in the experimental group [Time frame: Day 0 at the time of consultation]
• Results of the EQ-5D-5L questionnaire in the experimental group [Time frame: Week 12]
• Results of the EQ-5D-5L questionnaire in the sham group [Time frame: Day 0 at the time of consultation]
• Results of the EQ-5D-5L questionnaire in the sham group [Time frame: Week 12]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• CHU de Nîmes — Nîmes

Identifiers

NCT: NCT06226844 · ID-RCB 2023-A02245-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗