Early Evaluation of the Introduction of Pre- and Post-operative Psychological and Physiotherapeutic Follow-up in Vascular Surgery in Amputee Patients

Overview

An amputation represents a real ordeal for the person who will have to overcome the loss of a limb and face long months of rehabilitation. It is most often carried out following arterial insufficiency. As paramedical professionals, we see in our daily practice a physical and psychological suffering for amputee patients. In spite of our skills acquired through training and professional experience, we are unable to offer comprehensive care for these patients and therefore feel that we are offering incomplete care. A multidisciplinary care, including a medical and paramedical team, would seem to us to be more appropriate for patients with lower limb amputations. Following this observation, we would like to highlight the interest for the patient and the care team to include a psychologist and a physiotherapist in the care offer to evaluate the improvement of the physical and emotional state of the amputee patient.

Interventions

• Other Conventional support
  Patients in the "Conventional support" randomisation arm will follow the usual care of amputee patients in the vascular surgery department. They will be cared for by the surgeon, nurses and nursing auxiliaries, who will provide individualised care (nursing care, mobilisation, pain management, technical care, etc.), listening and support.
• Other Specific care, including the intervention of a psychologist and a physical therapist.
  In the case where the patient is in the "Specific care, including the intervention of a psychologist and a physical therapist." arm, the usual care will be associated with : * consultations with a psychologist * The patient will also be cared for on a daily basis by a physical therapist.

Primary outcome measures

• To evaluate the relevance of the intervention of a physical therapist and a psychologist in the management of amputee patients in vascular surgery at 10 days post-operatively. [Time frame: at 10 days post-operatively]

Eligibility criteria

Inclusion criteria

• Patient over the age of majority, no age limit
• Amputation related to obliterative arteriopathy of the lower limbs
• Trans-tibial or trans-femoral amputation
• Patient with an indication of discharge to a rehabilitation and re-education service
• Patient with the ability to understand the protocol
• Patient who has agreed to participate in the study and has given express oral consent
• Patient receiving social security cover or entitled to it

Exclusion criteria

• Trauma related amputation
• Amputation of upper limb, trans-metatarsal or one or more toes
• Amputation of comfort in a palliative care setting
• Patient leaving home after surgery
• Patient undergoing psychological or psychiatric treatment
• Pregnant or breastfeeding woman, or a woman who is able to procreate without effective contraception
• Patient unable to follow the protocol as judged by the investigator
• Patient participating in another interventional research protocol involving a drug or medical device
• Patient under guardianship, curators or legal protection measure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Departmental Hospital Centre - Vendee — La Roche-sur-Yon

Publications

• B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2. PMID 37276273

Identifiers

NCT: NCT04750876 · CHD20_0056

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗