Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale
研究概览
简要总结
The overall objective of this study is to conduct a two-group randomized trial to examine the efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function, return to sport, and quality of life outcomes in patients following ACL reconstruction (ACLR). The study consists of two treatment groups: telephone-based cognitive-behavioral based physical therapy for ACLR (CBPT-ACLR) and telephone-based Education. The central hypothesis is that the CBPT-ACLR participants relative to the Education group will demonstrate significantly greater improvement in postoperative outcomes at 12 months following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking (due to feasibility of employing study personnel to deliver and assess the study intervention);
- •14 to 35 years of age (children 14 and older have skeletal maturity and adults 35 and younger are less likely to have symptoms of knee osteoarthritis);
- •no previous surgery to either knee;
- •time from injury to surgery 12 months or less;
- •active participation in a sport on a weekly basis prior to injury
排除标准
- •bilateral simultaneous ACL reconstructions;
- •revision ACLR;
- •any concurrent ligament (MCL, LCL, or PCL) surgical procedures;
- •concurrent osteotomies or meniscus transplantations;
- •surgery secondary to trauma, tumor, or infection;
- •having workman's compensation insurance for surgery;
- •on active military duty;
- •medical history of schizophrenia or other psychotic disorder; and
- •unable to provide stable address and access to a telephone
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale
时间窗: Up to 12 months after ACLR surgery
knee function relating to sport/recreation
Marx Activity Rating Scale
时间窗: Up to 12 months after ACLR surgery
The Marx Activity Rating Scale measures knee function relating to running, cutting, decelerating, and pivoting.
次要结局
- EQ-5D(Up to 12 months after ACLR surgery)
- Subjective Patient Outcome for Return to Sports (SPORTS)(Up to 12 months after ACLR surgery)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale(Up to 12 months after ACLR surgery)
研究者
Kristin Archer
Associate Professor and Vice Chair of Research
Vanderbilt University Medical Center