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

NCT04750876 | Recruiting

• 1 other identifier: CHD20_0056
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventional support

ACTIVE COMPARATOR

Other: Conventional support

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

EXPERIMENTAL

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

Interventions

Conventional support 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.

Conventional support

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

Departmental Hospital Centre - Vendee

La Roche-sur-Yon, France

RECRUITING

Related Publications (1)

• 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 DERIVED

Study Officials

• Nathalie CORDON

  Departmental Hospital Centre - Vendee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura SOULARD

CONTACT

02 51 08 05 82; promotion.urc@ght85.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: April 8, 2021
• Primary Completion (Estimated): April 18, 2027
• Study Completion (Estimated): October 18, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

FR (1)