Effect of Functional Strength Training of Hip Abductors in Runners With Medial Tibial Stress :(Randomised Clinical Trail)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Frontal Plane Projection Angle
研究概览
简要总结
This study will be the first project to investigate the effect of functional strength training of hip abductors on pain, function, hip, and knee kinematics including contra-lateral pelvic drop angle (hip frontal plane projection angle) and dynamic knee valgus (knee frontal plane projection angle) in runners with medial tibial stress syndrome patients.
详细描述
Forty participants with medial tibial stress syndrome will be recruited from orthopedic out clinic of the faculty of Physical therapy, Cairo, University, and Gezira Youth Center. They will be asked to sign the informed consent form .
The selected participants will be randomly assigned to two groups using a simple randomization method to allocate participants to the groups through the available online website www.randomization.com considering the control group as active control group. A flow diagram according to the Consolidated Standards of Reporting Trials (CONSORT) statement will be presented to illustrate the progression of this clinical trial .
Sample size calculation was performed using G*POWER statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) based on data of knee valgus angle derived from Pourahmad et al., (2021) who investigated the effect of strengthening the abductor and external rotator on lower limb kinematics in volleyball players with patellofemoral complications. The sample size required for this study was approximately 15 subjects in each group. Calculation is made with α=0.05, power = 80% and effect size = 1.1. The sample size increased to 18 subjects per group for possible dropout of 20%.
For statistical analysis:
- Unpaired t-test will be conducted for comparison of the subject characteristics between groups.
- Chi- squared test will be conducted for comparison of sex distribution between groups.
- Mixed MANOVA will be conducted to investigate the effect of treatment on pain, function, contralateral pelvic drop angle and dynamic knee valgus.
- Post-hoc tests using the Bonferroni test were carried out for subsequent multiple comparison.
- Statistical measures will be performed through the statistical package for social studies (SPSS) version 25 for windows.
- The level of significance for all statistical tests will be set at p < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female Athletes (runners) with a referred diagnosis of MTSS for at least 1 month
- •Participants with bilateral affection, the most affected limb will be included in measurements.
- •Body mass index range between (18.5-25 kg /m2 )
排除标准
- •History of previous lower extremity surgery
- •Neurological problems that will affect lower extremity function
- •Recent or old fractures at lower limbs
- •Cognitive impairment
- •Medications (anti-inflammatory/muscle relaxant)
结局指标
主要结局
The Frontal Plane Projection Angle
时间窗: Change from baseline frontal plane projection angle at 8 weeks.
It is a measure of the degree of dynamic knee valgus during functional tasks. FPPA is an angle that consists of two lines. One line between the thigh and hip markers and the other line between the ankle and knee markers .So that,from a frontal view, when the knee marker is medial to a line from the ankle marker to the thigh marker,the FPPA is negative (knee valgus).While,The FPPA is positive if the knee marker is lateral to a line drawn from ankle marker to the thigh marker (knee varus).
The contra-lateral pelvic drop angle
时间窗: Change from baseline contra-lateral pelvic drop angle at 8 weeks.
It is determined as the angle subtended by one line connecting the anterior superior iliac spine with the stance and swing limb and a second line drawn perpendicular to the stance limb anterior superior iliac spine then, the measurement will be subtracted from 90 degrees.
次要结局
- Pain severity(8 weeks)
- Lower extremity function(8 weeks)
研究者
Shreen Lashien
Senior musculoskeletal physiotherapist ,faculty of physical therapy
Cairo University