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NCT Number: NCT06226844

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

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).

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Key information

Conditions

Atheromatous Artery Disease Lower Limb Ischemia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Atherosclerotic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes

Nîmes, 30029, France

Location status: Recruiting

Location contact

Jeremy LAURENT

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group.

    Time frame: 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.

  2. Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group.

    Time frame: 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.

  3. Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group.

    Time frame: 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.

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

    Time frame: 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.

  5. Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group.

    Time frame: 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.

  6. Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group.

    Time frame: 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.

Secondary outcomes

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

    Time frame: Day 0 at the time of consultation

    Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation

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

    Time frame: Week 12

    Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation

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

    Time frame: Day 0 at the time of consultation

    Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation

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

    Time frame: Week 12

    Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation

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

    Time frame: Day 0 at the time of consultation

    Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation

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

    Time frame: Week 12

    Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation

  7. Systolic pressure index at the toe after effort. Sham group

    Time frame: Day 0 at the time of consultation

    Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation

  8. Systolic pressure index at the toe after effort. Sham group

    Time frame: Week 12

    Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation

  9. Results of the EQ-5D-5L questionnaire in the experimental group

    Time frame: Day 0 at the time of consultation

    Patients will complete the EQ-5D-5L quality of life questionnaire before starting the walking training program and after completing it.

    The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

  10. Results of the EQ-5D-5L questionnaire in the experimental group

    Time frame: Week 12

    Patients will complete the EQ-5D-5L quality of life questionnaire before starting the walking training program and after completing it.

    The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

  11. Results of the EQ-5D-5L questionnaire in the sham group

    Time frame: Day 0 at the time of consultation

    Patients will complete the EQ-5D-5L quality of life questionnaire before starting the walking training program and after completing it.

    The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

  12. Results of the EQ-5D-5L questionnaire in the sham group

    Time frame: Week 12

    Patients will complete the EQ-5D-5L quality of life questionnaire before starting the walking training program and after completing it.

    The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

  13. Phone call follow-up in the experimental group

    Time frame: Week 4

    Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device.

    The following information will be be recorded during follow-up phone calls and will include any problems encountered with :

    • Using the smartphone,
    • Use of BeatMove
    • Use of ankle sensors
    • Physical problems encountered during rehabilitation sessions
    • Medical problems
    • The problem of time and organization
    • Motivation problem
    • Other problems

  14. Phone call follow-up in the sham group

    Time frame: Week 4

    Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device.

    The following information will be be recorded during follow-up phone calls and will include any problems encountered with :

    • Using the smartphone,
    • Use of BeatMove
    • Use of ankle sensors
    • Physical problems encountered during rehabilitation sessions
    • Medical problems
    • The problem of time and organization
    • Motivation problem
    • Other problems

  15. Phone call follow-up in the experimental group

    Time frame: Week 8

    Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device.

    The following information will be be recorded during follow-up phone calls and will include any problems encountered with :

    • Using the smartphone,
    • Use of BeatMove
    • Use of ankle sensors
    • Physical problems encountered during rehabilitation sessions
    • Medical problems
    • The problem of time and organization
    • Motivation problem
    • Other problems

  16. Phone call follow-up in the sham group

    Time frame: Week 8

    Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device.

    The following information will be be recorded during follow-up phone calls and will include any problems encountered with :

    • Using the smartphone,
    • Use of BeatMove
    • Use of ankle sensors
    • Physical problems encountered during rehabilitation sessions
    • Medical problems
    • The problem of time and organization
    • Motivation problem
    • Other problems

  17. Phone call follow-up in the experimental group

    Time frame: Week 12

    Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device.

    The following information will be be recorded during follow-up phone calls and will include any problems encountered with :

    • Using the smartphone,
    • Use of BeatMove
    • Use of ankle sensors
    • Physical problems encountered during rehabilitation sessions
    • Medical problems
    • The problem of time and organization
    • Motivation problem
    • Other problems

  18. Phone call follow-up in the sham group

    Time frame: Week 12

    Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device.

    The following information will be be recorded during follow-up phone calls and will include any problems encountered with :

    • Using the smartphone,
    • Use of BeatMove
    • Use of ankle sensors
    • Physical problems encountered during rehabilitation sessions
    • Medical problems
    • The problem of time and organization
    • Motivation problem
    • Other problems

  19. Patient's logbook: Pre- and post-workout pain rating in the experimental group

    Time frame: Three sessions per week for 3 months throughout the training program

    The patient's appreciation of pre- and post-workout pain will be recorded on a Lickert scale from 0 to 10 in which 0 = no pain, 10 = unbearable pain.

  20. Patient's logbook: Pre- and post-workout pain rating in the sham group

    Time frame: Three sessions per week for 3 months throughout the training program

    The patient's appreciation of pre- and post-workout pain will be recorded on a Lickert scale from 0 to 10 in which 0 = no pain, 10 = unbearable pain.

  21. Patient's logbook: Pre- and post-workout evaluation of fatigue in the experimental group

    Time frame: Three sessions per week for 3 months throughout the training program

    Evaluation of fatigue before and after training (Lickert scale from 0 to 10 in which 0 = no fatigue, 10 = greatest possible fatigue).

  22. Patient's logbook: Pre- and post-workout evaluation of fatigue in the sham group

    Time frame: Three sessions per week for 3 months throughout the training program

    Evaluation of fatigue before and after training (Lickert scale from 0 to 10 in which 0 = no fatigue, 10 = greatest possible fatigue).

  23. Patient's logbook: Pre- and post-workout evaluation of motivation in the experimental group

    Time frame: Three sessions per week for 3 months throughout the training program

    Evaluation of motivation before and after training (Lickert scale from 0 to 10 in which 0 = no motivation, 10 = greatest possible motivation).

  24. Patient's logbook: Pre- and post-workout evaluation of motivation in the sham group

    Time frame: Three sessions per week for 3 months throughout the training program

    Evaluation of motivation before and after training (Lickert scale from 0 to 10 in which 0 = no motivation, 10 = greatest possible motivation).

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

+33466684236

Jérémy LAURENT, Dr.

CONTACT

[email protected]

+334 66 68 33 13

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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.

Acronym: LEGS GO

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2024
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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