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

ConditionAmputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Departemental Vendee

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional support

    Other intervention

    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.

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Conventional supportActive comparator 1 intervention
Group B: Specific care, including the intervention of a psychologist and a physical therapist.Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
at 10 days post-operatively

Secondary outcomes

Other outcomes

Sponsors and contacts

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