Analysis Of Knee Joint Stability, Functional Capacity, Postural Control, Activation And Muscle Strength Of Patients With Anterior Cruciate Ligament Injury Undergoing Physiotherapy After Two Different Surgical Techniques: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Articular Range of Motion
研究概览
简要总结
The objetive is compare knee joint stability, functional capacity, postural control, activation, and muscle strength of patients undergoing conventional Anterior Cruciate Ligament Reconstruction or the conventional Anterior Cruciate Ligament Reconstruction + Anterolateral Ligament Reconstruction technique of the knee, and rehabilitation for up to nine months. This project aims to include patients with ACL injuries already treated at the Knee Outpatient Clinic of the Hospital das Clínicas da UEL (HC-UEL), coordinated by the orthopedic physician Dr. Lucas da Fonseca Borghi, who has his master's degree related to this research project. Twenty patients between 18 and 50 years old, of both sexes, sedentary and/or active and/or athletes, diagnosed with unilateral injury of the Anterior Cruciate Ligament will be included. These patients will be evaluated, submitted to ACL surgery (conservative) or associated with ALL reconstruction and undergo rehabilitation with physiotherapy in conjunction with the extension project Sports Physiotherapy from Theory to Practice - Phase III (PROEX-UEL No 02675), coordinated by Prof. Dr. Christiane S. Guerino Macedo - advisor of this research. Expected results: It is expected that the group undergoing ACL + ALL reconstruction will present better knee joint stability, functional capacity, postural control, activation and muscle strength.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants with 18 to 50 years old; - both sexes; - sedentary; -active; - athletes; - diagnosed unilateral ACL injury; - patients residing in the city of Londrina - PR.
排除标准
- •BMI (Body Mass Index) above 35 kg/m2; - multidirectional ligament laxity; - associated multiligament injury (PCL and posterolateral corner); - previous or current lower limb fractures; - previous ACL reconstruction (revision); - signs of osteoarthritis; - indication for meniscus suture; - neurological disease; - pregnant women; - heart disease; - previous lower limb surgeries.
研究组 & 干预措施
Group 1 conventional ACL reconstruction with quadruple flexor tendons and conventional physiotherapy
This surgery is performed with the aid of videoarthroscopy in a minimally invasive manner. The procedure begins with the collection of the muscle graft that will be used for ACL reconstruction. The semitendinosus and gracilis muscles, also known as flexor tendons, will be used. All the participants will receive conventional physiotherapy with rehabilitation protocol with manual therapy, physical resources (heat, cold, electrotherapy), kinesiotherapy, and isokinetic exercises. All participants will be evaluated and re-evaluated in the same way.
干预措施: Group 1 ACL reconstruction with quadruple flexor tendons and conventional physiotherapy (Procedure)
Group 2 (combined ACL + ALL reconstruction) and conventional physiotherapy
Group 2 will undergo conventional ACL + ALL reconstruction in a similar manner to group 1 with quadruple flexor graft (triple semitendinosus and single gracilis). For combined ACL + ALL reconstruction, it is performed through a conventional tibial tunnel with a 55-degree angulation guide and a diameter defined by the thickness of the graft. All the participants will receive conventional physiotherapy with rehabilitation protocol with manual therapy, physical resources (heat, cold, electrotherapy), kinesiotherapy, and isokinetic exercises. All participants will be evaluated and re-evaluated in the same way.
干预措施: Group 2 ACL reconstruction with quadruple flexor tendons + ALL reconstruction (Procedure)
结局指标
主要结局
Articular Range of Motion
时间窗: preoperative and postoperative (5, 15, 30, 60 and 120 days).
Assessment of hip and knee range of motion (Hip Internal Rotation Mobility and Lunge Test).
Functional Capacity
时间窗: preoperative and postoperative (5, 15, 30, 60 and 120 days).
Lysholm Knee Scoring Scale: Eight questions, with closed answer alternatives, whose final result is expressed in nominal and ordinal form.
Isometric Muscle Strength
时间窗: preoperative and postoperative (5, 15, 30, 60 and 120 days).
Dynamometer (SP MEDEOR/TECH), connecting it via Bluetooth to the My SP Tech application for verification to check the strength of knee flexors and extensors.
次要结局
- Gait through the GaitRite program(postoperative 5, 15, 30, 60 and 10 days.)
- Functional Tests(preoperative and postoperative (5, 15, 30, 60 and 120 days).)
- Analysis of postural control(preoperative and postoperative (5, 15, 30, 60 and 120 days).)
- Analysis of muscle activation by surface electromyography(preoperative and postoperative (5, 15, 30, 60 and 120 days).)
研究者
Christiane Macedo
Principal Investigator PhD
Universidade Estadual de Londrina