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

NCT06226844 | Recruiting

• 1 other identifier: ID-RCB 2023-A02245-40
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Atheromatous; Lower Limb Ischemia; Artery Disease

Keywords

Rehabilitation; Music therapy

Outcome Measures

Primary Outcomes (6)

• 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.

  Week 4

• 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.

  Week 4

• 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.

  Week 8

• 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.

  Week 8

• 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.

  Week 12

• 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.

  Week 12

Secondary Outcomes (24)

• Systolic pressure index at the toe at rest. Experimental group

  Day 0 at the time of consultation

• Systolic pressure index at the toe at rest. Experimental group

  Week 12

• Systolic pressure index at the toe after effort. Experimental group

  Day 0 at the time of consultation

• Systolic pressure index at the toe after effort. Experimental group

  Week 12

• Systolic pressure index at the toe at rest. Sham group

  Day 0 at the time of consultation

Study Arms (2)

Control group : PEMA SHAM

SHAM COMPARATOR

Patients on rehabilitation using the BeatMove device in sham mode

Device: Sham BeatMove

Experimental group : PEMA BeatMove

EXPERIMENTAL

Patients on rehabilitation using the BeatMove device

Device: Music therapy walking program

Interventions

Music therapy walking program DEVICE

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

Experimental group : PEMA BeatMove

Sham BeatMove DEVICE

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.

Control group : PEMA SHAM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jérémy LAURENT, Dr.

CONTACT

+334 66 68 33 13; jeremy.laurent@chu-nimes.fr

Anissa MEGZARI

CONTACT

+33466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 26, 2024
• Study Start: June 14, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-10

Locations

FR (1)