Normalization of Gait After ACL Reconstruction: A Comparative Study Between Home-based Versus Standardized Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 5
- 主要终点
- Changes in step length
研究概览
简要总结
The objective of this study is to evaluate the regaining of a normal gait within the early rehabilitation (12-13 weeks postsurgical) after reconstruction of the anterior cruciate ligament (ACL). Therefore, two different rehabilitation programs (supervised versus home-based) will be compared.
A prospective, parallel-grouped trial with patients´ free choice of postsurgical therapy (home based versus supervised) will be conducted. One group will receive a well supervised, standardized rehabilitation program, while the other group will be instructed in a home-based rehabilitation program. Gait assessments will be carried out 6-7 weeks and 12-13 weeks postsurgical using standard 3D clinical gait analysis. Complementary, gait will also be evaluated using an Inertial Measurement Unit (IMU) three times postsurgical (6-7 weeks, 9-10 weeks, 12-13 weeks). Furthermore, various clinical parameters, like patient reported outcome measures (PROM), knee swelling, range of motion (ROM) will be taken presurgical as well as on days of gait assessment.
The study will show the impact of physiotherapeutic therapy on the early normalization of gait after ACL reconstruction. The results may help to build a better understanding of the required physiotherapeutic supervision after ACL surgery and if a home-based therapy can safely be recommended to specific patients.
详细描述
Design:
The study is designed as a prospective, parallel-grouped trial. The patient will have the free choice out of two postsurgical rehabilitation regimens. The baseline assessments will take place presurgical after the official enrolment procedure. After surgery, three follow ups are set (6-7, 9-10, 12-13 weeks postsurgical). 3D gait analysis will be performed on first and third series. Additionally, IMU gait analysis as well as the modified Star Excursion Balance Test (SEBT) will be performed . Furthermore, various clinical parameters, like patient reported outcome measures (PROM), knee swelling, range of motion (ROM) will be taken on assessment days.
Enrolment/Allocation/Blinding:
An appointment for checking eligibility will be made presurgical. If the patient is eligible, a signed informed consent will be collected and a continuous identification number will be defined by a central study coordinator. Further, the general personal data will be assessed, and presurgical measurements (e.g. ROM, knee swelling, PROM, height, weight) will be performed.
After surgery the patients can choose between a standardized rehabilitation program at the department of physical medicine and rehabilitation at University Hospital Krems (UHK) or a supervised home-based program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
A blinding of the patients is not possible, due to the nature of the study and the obviosity of group allocation. The principal investigator will be blinded to the allocation and will only get access to the coding list in special cases (e.g. harm). Furthermore, the principal investigator is not involved in the statistical analysis of data.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery at University Hospital Krems (UHK), Austria
- •Age 18-60 years
- •Surgery-timing less than six months posttraumatic
- •Isolated ACL rupture with or without small concomitant injuries
排除标准
- •Relevant concomitant injuries of the musculoskeletal system
- •Old injuries of the lower limbs, which influence the normal gait pattern (including ACL re-ruptures)
- •Relevant orthopaedic pre-existing conditions, especially of the lower limbs.
- •Severe internistic and neurological concomitant diseases, which have an impact on the cardiorespiratory fitness or the physiologic gait
- •Patients who do not speak or understand the German or English language properly
结局指标
主要结局
Changes in step length
时间窗: 6-7 and 12-13 weeks after ACL reconstruction
The primary outcome will be the regaining of a symmetrical step length in 3D gait analysis. Therefor, the symmetry index by Robinson et al. will be used. Data will be collected using a motion capture system (VICON, Oxford, UK), comprising of 12 infrared-cameras at a sampling rate of 150 Hz A full body marker set with a total of 50 retro-reflective spherical markers with a diameter of 14 mm and 9 mm will be attached bilaterally on each participant using double-sided tape. Markers will be placed at bony landmarks according to the manual of the Cleveland Clinic Marker Set and the Plug in Gait model (upper extremity). The 3D marker trajectories of all markers will be reconstructed and processed using the VICON Nexus analysis software (v. 2.5, Oxford, UK). Kinetic data will be collected simultaneously by using three force plates (AMTI, Watertown, USA) at a sampling rate of 1500 Hz.
次要结局
- Kinematic pelvic parameters (IMU)(6-7, 9-10, 12-13 weeks after ACL reconstruction)
- Range of Motion (knee)(Presurgical, 6-7, 9-10, 12-13 weeks after ACL reconstruction)
- Kinetic gait parameters (3D gait analysis)(6-7 and 12-13 weeks after ACL reconstruction)
- Temporal gait parameters (3D+IMU)(6-7, 9-10, 12-13 weeks after ACL reconstruction)
- Knee circumference(Presurgical, 6-7, 9-10, 12-13 weeks after ACL reconstruction)
- International Knee Documentation Committee Subjective Knee Form (IKDC)(Presurgical, 6-7, 9-10, 12-13 weeks after ACL reconstruction)
- Kinematic gait parameters (3D gait analysis)(6-7 and 12-13 weeks after ACL reconstruction)
- Step length (IMU)(6-7, 9-10, 12-13 weeks after ACL reconstruction)
- Modified Star Excursion Balance Test (mSEBT)(12-13 weeks postsurgical)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Presurgical, 6-7, 9-10, 12-13 weeks after ACL reconstruction)
- Modified Lysholm Score(Presurgical, 6-7, 9-10, 12-13 weeks after ACL reconstruction)
- Tegner activity score(Presurgical and 12-13 weeks after ACL reconstruction)