Early Psychological and Physiotherapy Follow-up After Lower-Limb Amputation
Official title: Early Evaluation of the Introduction of Pre- and Post-operative Psychological and Physiotherapeutic Follow-up in Vascular Surgery in Amputee Patients
Run by Centre Hospitalier Departemental Vendee · NCT04750876 · Data updated 2026-11-12
We’re testing if adding a psychologist and a physiotherapist before and after surgery helps improve physical and emotional well-being for adults with lower-limb amputations.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Centre Hospitalier Departemental Vendee Academic / other |
| Locations | 1 site (La Roche-sur-Yon) |
| Status | Recruiting |
| Started | April 8, 2021 |
| Main results expected | April 18, 2027 |
| Study ends | October 18, 2027 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT04750876 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with lower-limb amputation due to obliterative arteriopathy who are planning discharge to rehabilitation services.
✕Probably not a fit
Patients with trauma-related amputation, upper-limb amputations, or those already receiving ongoing psychological or psychiatric treatment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines a coordinated care approach that includes psychological support and physiotherapy integrated with standard care for adults undergoing below- or above-knee amputations due to vascular disease. The goal is to see whether structured pre- and post-operative follow-up improves rehabilitation outcomes and emotional health. Participants receive conventional care plus targeted psychological and physical therapy interventions. The study does not have a defined phase structure and focuses on feasibility and potential benefit in real-world hospital settings.
Why it matters
Potential benefit: If successful, patients may experience better emotional adjustment and faster, more effective physical rehabilitation after amputation.
How similar studies have gone: Prior multidisciplinary approaches in amputation care have shown promise, but this specific pre- and post-operative psychologist and physiotherapist integration is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Departmental Hospital Centre - Vendee
La Roche-sur-Yon, France Recruiting
Study contacts
- Principal investigator: Nathalie CORDON — Departmental Hospital Centre - Vendee
- Study coordinator: Laura SOULARD
- Email: promotion.urc@ght85.fr
- Phone: 02 51 08 05 82
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.