AtheromatousLEGS GONCT06226844
Can the BeatMove Device Help Patients With Obliterative Arterial Disease of the Lower Limbs?
A study testing Music therapy walking program in people with Atheromatous and Lower Limb Ischemia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atheromatous, Lower Limb Ischemia, Artery Disease
- What is being tested?
- Music therapy walking program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2024to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients using walking aids (cane, wheelchair)
- Amputation
- Patient with a walking perimeter < 150 m
- Hearing or visual impairment
- Chronic ischaemia
- Trophic disorders
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
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).
Read the 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).
- Conditions
- Atheromatous, Lower Limb Ischemia, Artery Disease
- Being tested
- Music therapy walking program, Sham BeatMove
- Keywords
- Rehabilitation, Music therapy
- Medical subject headings
- Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy walking programDevice
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 BeatMoveDevice
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 group | Role | What they receive |
|---|---|---|
| Control group : PEMA SHAM | Sham comparator | Patients on rehabilitation using the BeatMove device in sham mode Receives: Device: Sham BeatMove |
| Experimental group : PEMA BeatMove | Experimental | Patients on rehabilitation using the BeatMove device Receives: Device: Music therapy walking program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
Secondary outcomes (24)
Systolic pressure index at the toe at rest. Experimental group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Measured: Day 0 at the time of consultation
Systolic pressure index at the toe at rest. Experimental group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Measured: Week 12
Systolic pressure index at the toe after effort. Experimental group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Measured: Day 0 at the time of consultation
Systolic pressure index at the toe after effort. Experimental group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Measured: Week 12
Systolic pressure index at the toe at rest. Sham group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Measured: Day 0 at the time of consultation
Systolic pressure index at the toe at rest. Sham group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Measured: Week 12
Systolic pressure index at the toe after effort. Sham group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Measured: Day 0 at the time of consultation
Systolic pressure index at the toe after effort. Sham group
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation
Measured: Week 12
Results of the EQ-5D-5L questionnaire in the experimental group
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.
Measured: Day 0 at the time of consultation
Results of the EQ-5D-5L questionnaire in the experimental group
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.
Measured: Week 12
Results of the EQ-5D-5L questionnaire in the sham group
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.
Measured: Day 0 at the time of consultation
Results of the EQ-5D-5L questionnaire in the sham group
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.
Measured: Week 12
Phone call follow-up in the experimental group
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
Measured: Week 4
Phone call follow-up in the sham group
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
Measured: Week 4
Phone call follow-up in the experimental group
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
Measured: Week 8
Phone call follow-up in the sham group
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
Measured: Week 8
Phone call follow-up in the experimental group
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
Measured: Week 12
Phone call follow-up in the sham group
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
Measured: Week 12
Patient's logbook: Pre- and post-workout pain rating in the experimental group
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.
Measured: Three sessions per week for 3 months throughout the training program
Patient's logbook: Pre- and post-workout pain rating in the sham group
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.
Measured: Three sessions per week for 3 months throughout the training program
Patient's logbook: Pre- and post-workout evaluation of fatigue in the experimental group
Evaluation of fatigue before and after training (Lickert scale from 0 to 10 in which 0 = no fatigue, 10 = greatest possible fatigue).
Measured: Three sessions per week for 3 months throughout the training program
Patient's logbook: Pre- and post-workout evaluation of fatigue in the sham group
Evaluation of fatigue before and after training (Lickert scale from 0 to 10 in which 0 = no fatigue, 10 = greatest possible fatigue).
Measured: Three sessions per week for 3 months throughout the training program
Patient's logbook: Pre- and post-workout evaluation of motivation in the experimental group
Evaluation of motivation before and after training (Lickert scale from 0 to 10 in which 0 = no motivation, 10 = greatest possible motivation).
Measured: Three sessions per week for 3 months throughout the training program
Patient's logbook: Pre- and post-workout evaluation of motivation in the sham group
Evaluation of motivation before and after training (Lickert scale from 0 to 10 in which 0 = no motivation, 10 = greatest possible motivation).
Measured: Three sessions per week for 3 months throughout the training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start14 Jun 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtheromatousStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226844
- Sponsor's protocol ID
- ID-RCB 2023-A02245-40
- Acronym
- LEGS GO
- Status last verified
- Oct 2025
- First submitted
- 18 Jan 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06226844
- Acronym / sponsor ID
- LEGS GO / ID-RCB 2023-A02245-40
- Conditions
- Atheromatous, Lower Limb Ischemia, Artery Disease
- Keywords
- Rehabilitation, Music therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group : PEMA SHAM | Sham comparator | Device: Sham BeatMovePatients on rehabilitation using the BeatMove device in sham mode |
| Experimental group : PEMA BeatMove | Experimental | Device: Music therapy walking programPatients on rehabilitation using the BeatMove device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Patients using walking aids (cane, wheelchair)
- Amputation
- Patient with a walking perimeter < 150 m
- Hearing or visual impairment
- Chronic ischaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapy walking programIn 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 | Experimental group : PEMA BeatMove |
| Sham BeatMoveAmbulatory 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. | Device | Control group : PEMA SHAM |
Primary outcome
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.
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.
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.
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.
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.
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.
24 secondary outcomes
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
Phone call follow-up in the experimental group
Time frame: Week 4
Phone call follow-up in the sham group
Time frame: Week 4
Phone call follow-up in the experimental group
Time frame: Week 8
Phone call follow-up in the sham group
Time frame: Week 8
Phone call follow-up in the experimental group
Time frame: Week 12
Phone call follow-up in the sham group
Time frame: Week 12
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy walking program in people with Atheromatous and Lower Limb Ischemia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérémy LAURENT, Dr. (+334 66 68 33 13, jeremy.laurent@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group. (time frame: Week 4). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.