Early Evaluation of the Introduction of Pre- and Post-operative Psychological and Physiotherapeutic Follow-up in Vascular Surgery in Amputee Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Conventional support
干预措施: Conventional support (Other)
Specific care, including the intervention of a psychologist and a physical therapist.
干预措施: Specific care, including the intervention of a psychologist and a physical therapist. (Other)
结局指标
主要结局
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.
时间窗: 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.
次要结局
未报告次要终点