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

Amputation Clinical Trial

— EPKIVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04750876
• Other study ID #: CHD20_0056
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: October 2023

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Departemental Vendee
• Contact: Laura SOULARD
• Phone: 02 51 08 05 82
• Email: laura.soulard[@]ght85.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Departmental Hospital Centre - Vendee	La Roche Sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Mobility" and "Emotional Reactions" scores collected from the Nottingham Health Profile (NHP) scale at 10 days post-operatively; It is a self-questionnaire for measuring perceived health in the general population or in patients. It allows the measurement of health-related quality of life. It is in the form of a questionnaire with 38 questions to which the patient must answer "yes" or "no". A score of 1 point will be awarded for a positive answer and 0 points for a negative answer.; A score between 0 and 100 is thus obtained for each patient for each item. This percentage corresponds to the degree of difficulty perceived by the subject in the area of each of the headings.	at 10 days post-operatively