Randomized Study Evaluating the Value of a Pre-habilitation Stay and Digital Follow-up, Compared With Standard Management, in Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- State-Trait Anxiety Inventory questionnaire
研究概览
简要总结
This study evaluates the effectiveness of a pre-habilitation stay via digital monitoring on patients' short-term post-operative anxiety, compared with conventional management.
详细描述
This is a prospective, comparative, randomized (2-arm), controlled, single-center study of two management modalities.
Recruitment will focus on adult patients with anterior cruciate ligament rupture and scheduled anterior cruciate ligament surgical reconstruction. Patients will be randomized into 2 arms, an experimental arm A (pre-habilitation management) and a control arm B (conventional management).
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
- •Partial or complete tear of the anterior cruciate ligament;
- •Scheduled anterior cruciate ligament reconstructive surgery;
- •Patient with a tablet, computer or smartphone with an internet connection;
- •Patient able to understand and read French;
- •Willingness to complete questionnaires at regular intervals;
- •Membership of a social security scheme;
- •Signed informed consent.
排除标准
- •History of anterior cruciate ligament surgery within the past 5 years;
- •Stage III collateral ligament injury;
- •Osteotomy;
- •Neurological (motor and/or sensory), vestibular or rheumatic pathology;
- •Pregnant or breast-feeding woman;
- •Protected adult patient (under guardianship, curatorship or deprivation of liberty).
研究组 & 干预措施
conventional care
During their pre-operative visit with the surgeon, patients will receive a booklet containing information on the peri-operative period, possible complications, how to prevent them and what to do should they occur. Patients will benefit from standard computerized follow-up, as well as the scheduled surgical procedure (anterior cruciate ligament reconstruction) and the usual peri-operative medical follow-up.
干预措施: Reconstructive surgery of the anterior cruciate ligament (Procedure)
pre-habilitation stays
Pre-habilitation involves taking part in a half-day information session led by a physiotherapist and a nurse prior to surgery. Patients will benefit from digital monitoring via the Orthense application, as well as scheduled surgery (anterior cruciate ligament reconstruction) and the usual peri-operative medical follow-up.
干预措施: Reconstructive surgery of the anterior cruciate ligament (Procedure)
结局指标
主要结局
State-Trait Anxiety Inventory questionnaire
时间窗: 7 days
The main evaluation criterion is the total "state-anxiety" score of the State-Trait Anxiety Inventory questionnaire on 7 days compared to the score measured at least 25 days (i.e. baseline value: before the surgical intervention and before the pre-habilitation stay taking place for patients in the experimental group)
次要结局
未报告次要终点