Lower Limb Ischemia Clinical Trial
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).
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). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02408991 -
Use Art-assist and Neupogen to Treat Chronic Limb Ischemia
|
Phase 4 | |
| Completed |
NCT02369809 -
Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia
|
Phase 4 | |
| Not yet recruiting |
NCT05569369 -
Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions
|
N/A | |
| Active, not recruiting |
NCT02856230 -
An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT03295539 -
Acute Limb Ischaemia (ALI) Management With 'Indigo' Mechanical Aspiration System
|
N/A | |
| Not yet recruiting |
NCT04277702 -
Cysteinyl Leukotriene Antagonist in Atherosclerosis Inhibition in Patients After Endovascular Treatment Due to Peripheral Arterial Disease
|
Phase 3 | |
| Recruiting |
NCT02304588 -
Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot
|
Phase 1 | |
| Recruiting |
NCT01937416 -
Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia
|
Phase 1 | |
| Completed |
NCT05601349 -
TeleEducation for Implementing a Clinical Practice Guideline For Amputees
|
N/A | |
| Active, not recruiting |
NCT01305863 -
Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft
|
N/A | |
| Completed |
NCT04533035 -
Lower Limb Tissue Oxygenation Using Near-infrared Spectroscopy During Hallux Valgus Operation
|
||
| Completed |
NCT03910062 -
Lower Limb Surveillance During VA-ECLS
|