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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
54
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
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.
CHU de Nîmes
Nîmes, France
RECRUITINGBenefit 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 12
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 0 at the time of consultation
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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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
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
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.
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
Evaluation of fatigue before and after training (Lickert scale from 0 to 10 in which 0 = no fatigue, 10 = greatest possible fatigue).
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
Evaluation of fatigue before and after training (Lickert scale from 0 to 10 in which 0 = no fatigue, 10 = greatest possible fatigue).
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
Evaluation of motivation before and after training (Lickert scale from 0 to 10 in which 0 = no motivation, 10 = greatest possible motivation).
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
Evaluation of motivation before and after training (Lickert scale from 0 to 10 in which 0 = no motivation, 10 = greatest possible motivation).
Time frame: Three sessions per week for 3 months throughout the training program