Lower Limb Ischemia Clinical Trial
— LEGS GOOfficial 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).
Status | Not yet recruiting |
Enrollment | 44 |
Est. completion date | November 1, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | Day 0 at the time of consultation | |
Secondary | 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 | Week 12 | |
Secondary | 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 | Day 0 at the time of consultation | |
Secondary | 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 | Week 12 | |
Secondary | 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 | Day 0 at the time of consultation | |
Secondary | 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 | Week 12 | |
Secondary | 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 | Day 0 at the time of consultation | |
Secondary | 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 | Week 12 | |
Secondary | 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. |
Day 0 at the time of consultation | |
Secondary | 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. |
Week 12 | |
Secondary | 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. |
Day 0 at the time of consultation | |
Secondary | 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. |
Week 12 | |
Secondary | 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 |
Week 4 | |
Secondary | 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 |
Week 4 | |
Secondary | 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 |
Week 8 | |
Secondary | 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 |
Week 8 | |
Secondary | 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 |
Week 12 | |
Secondary | 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 |
Week 12 | |
Secondary | 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. | Three sessions per week for 3 months throughout the training program | |
Secondary | 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. | Three sessions per week for 3 months throughout the training program | |
Secondary | 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). | Three sessions per week for 3 months throughout the training program | |
Secondary | 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). | Three sessions per week for 3 months throughout the training program | |
Secondary | 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). | Three sessions per week for 3 months throughout the training program | |
Secondary | 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). | Three sessions per week for 3 months throughout the training program |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
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