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

NCT ID: NCT06226844

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-14

Study Completion Date

2027-11-01

Brief Summary

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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

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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).

Conditions

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Atheromatous Lower Limb Ischemia Artery Disease

Keywords

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Rehabilitation Music therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control group : PEMA SHAM

Patients on rehabilitation using the BeatMove device in sham mode

Group Type SHAM_COMPARATOR

Sham BeatMove

Intervention Type 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.

Experimental group : PEMA BeatMove

Patients on rehabilitation using the BeatMove device

Group Type EXPERIMENTAL

Music therapy walking program

Intervention Type 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

Interventions

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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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nîmes

Nîmes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jérémy LAURENT, Dr.

Role: CONTACT

Phone: +334 66 68 33 13

Email: [email protected]

Anissa MEGZARI

Role: CONTACT

Phone: +33466684236

Email: [email protected]

Facility Contacts

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Jeremy LAURENT

Role: primary

Other Identifiers

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ID-RCB 2023-A02245-40

Identifier Type: -

Identifier Source: org_study_id