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

NCT ID: NCT04750876

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2023-10-31

Brief Summary

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.

Conditions

Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Conventional support

Group Type: ACTIVE_COMPARATOR

Conventional support

Intervention Type: OTHER

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.

Specific care, including the intervention of a psychologist and a physical therapist.

Group Type: EXPERIMENTAL

Specific care, including the intervention of a psychologist and a physical therapist.

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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 in an already amputated patient
• 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
• Patient with no history of 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie CORDON

Role: PRINCIPAL_INVESTIGATOR

Departmental Hospital Centre - Vendee

Locations

Departmental Hospital Centre - Vendee

La Roche-sur-Yon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Laura SOULARD

Role: CONTACT

laura.soulard@ght85.fr

02 51 08 05 82

References

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.

Reference Type: DERIVED

PMID: 37276273 (View on PubMed)

Other Identifiers

CHD20_0056

Identifier Type: -

Identifier Source: org_study_id