Development and Validation of the RISE-ACL Scale for Assessing Risk-Taking Intension and Propensity After ACL Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- The RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction.
研究概览
简要总结
Psychological factors play a critical role in recovery following anterior cruciate ligament (ACL) reconstruction. While tools such as the ACL - Return to Sport after Injury (ACL-RSI) focus on psychological readiness, emphasizing fear, hesitation, and apprehension, the opposite spectrum-overconfidence and risk-taking behaviors-remains underexplored. These behaviors can lead to premature return to high-risk activities and an increased likelihood of re-injury.
To address this gap, we propose the development and validation of the RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction. This scale will assess key factors such as patients' willingness to engage in high-impact activities, their adherence to medical guidance, and their perceived readiness to resume sports despite potential physical or psychological limitations.
The RISE-ACL Scale will complement existing tools like the ACL-RSI by focusing on overconfidence and risk-taking, offering clinicians a more balanced perspective on psychological recovery. Validation of the scale will involve testing its validity, reliability and clinical utility to ensure accurate identification of at-risk individuals.
By providing actionable insights, the RISE-ACL Scale will help enhance post-operative care, promote safer return-to-play decisions, and optimize long-term outcomes through a comprehensive assessment of psychological and behavioral factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have had an ACL reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery)
- •Patient included in the sport medicine follow-up protocole
- •Patients who have provided informed consent.
排除标准
- •Participants who are not included in the Return-to-sport process
研究组 & 干预措施
Group of experts in the field of ACL reconstruction surgery and follow-up
A group of 11 experts in the field of ACL reconstruction, each with a minimum of five years of experience and at least 100 patients managed, will collaborate to select the items to be included in the RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction.
干预措施: RISE-ACL development (Behavioral)
ACL - reconstruction group, scale validation
162 patients who have undergone ACL reconstruction within the past two years and are currently in the 'Return to Sport' process, with follow-up in the sports medicine department, will complete the RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction.
干预措施: RISE-ACL scale validation (Behavioral)
结局指标
主要结局
The RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction.
时间窗: One measurement during one visit at 4 to 24 months after surgery
The RISE-ACL Scale will measure patients' risk-taking tendencies, overconfidence in their recovery, and willingness to resume sports despite physical or psychological limitations. The number and nature of the items will be defined during the development phase. The scale will be scored on a Likert scale ranging from 0 to 3, with 0 representing "strongly disagree" and 3 representing "strongly agree."
次要结局
- Individual characteristics - gender(One measurement during one visit at 4 to 24 months after surgery)
- ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)(One measurement during one visit at 4 to 24 months after surgery)
- Individual - age(One measurement during one visit at 4 to 24 months after surgery)
- Strength(One measurement during one visit at 4 to 24 months after surgery)
- Surgery characteristics(One measurement during one visit at 4 to 24 months after surgery)
- IKDC Subjective Knee Evaluation(One measurement during one visit at 4 to 24 months after surgery)
- Individual characteristics - gender(One measurement during one visit at 4 to 24 months after surgery)
- Individual characteristics - sport(One measurement during one visit at 4 to 24 months after surgery)
- Individual characteristics - return to sport(One measurement during one visit at 4 to 24 months after surgery)
- ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)(One measurement during one visit at 4 to 24 months after surgery)
- Individual - age(One measurement during one visit at 4 to 24 months after surgery)
- Strength(One measurement during one visit at 4 to 24 months after surgery)
- Surgery characteristics(One measurement during one visit at 4 to 24 months after surgery)
- IKDC Subjective Knee Evaluation(One measurement during one visit at 4 to 24 months after surgery)
- RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction for test-retest reliability(Two measurements at a 5-day interval)
- Individual characteristics - sport(One measurement during one visit at 4 to 24 months after surgery)
- Individual characteristics - return to sport(One measurement during one visit at 4 to 24 months after surgery)
研究者
Joffrey DRIGNY
Maître de conférences des universités - praticien hospitalier (MCU-PH), M.D, Ph.D
University Hospital, Caen