Effect of Functional Strength Training of Hip Abductors in Runners With Medial Tibial Stress Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Functional Strength Training of Hip Abductors in Runners With Medial Tibial Stress :(Randomised Clinical Trail)

Conditions
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Medial Tibial Stress Syndrome

Intervention / Treatment
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* Other: Functional strength training of hip abductors
* Other: A selected physical therapy exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ) Exclusion Criteria: 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) Tumours

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (Active control group)<br>Group A (number=20): which is the control group with medial tibial stress syndrome, they will receive a selected physical therapy exercise program. | Other: A selected physical therapy exercise program<br>* Every participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises: Strength dorsiflexors of the ankle-using rubber band. Eccentric calf exercise (calf raise) . Balance and proprioceptive exercise using wobble boards. Stretch planter flexors (three sets of thirty repetitions, thirty seconds rest in between, three times per week)<br>* Other names: Common established treatment exercises;|
| Experimental: Group B (Experimental group)<br>Group B (number=20): which is the experimental group with Medial tibial stress syndrome, they will receive the same physical therapy exercise program as group A in addition to, functional strength training of hip abductors. | Other: Functional strength training of hip abductors<br>* Every participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises: Pelvic drop. Single leg -bridge. Side-lying hip abduction with hip internal rotation. Lateral step-up. Standing hip abduction on stance or swing leg with extra resistance .<br>Other: A selected physical therapy exercise program<br>* Every participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises: Strength dorsiflexors of the ankle-using rubber band. Eccentric calf exercise (calf raise) . Balance and proprioceptive exercise using wobble boards. Stretch planter flexors (three sets of thirty repetitions, thirty seconds rest in between, three times per week)<br>* Other names: Common established treatment exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Frontal Plane Projection Angle | 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). | Change from baseline frontal plane projection angle at 8 weeks. | 
| The contra-lateral pelvic drop angle | 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. | Change from baseline contra-lateral pelvic drop angle at 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity | Through using the visual analogue scale to detect the change from the baseline pain severity at eight weeks exercises treatment program. The participant will be asked to assess the worst pain level experience at last three days. The pain visual analogue scale is a uni-dimensional measure of pain severity,a straight horizontal line of fixed length,usually 10 cm.Using a ruler, the score is determined by measuring the distance (mm)on the 10-cm line between the no pain anchor and the patient's mark,providing a range of scores from 0-100. A higher score indicates greater pain intensity,while a lower score indicates lesser pain | 8 weeks | 
| Lower extremity function | Through using the lower extremity functional scale to detect the change from the baseline lower extremity function at eight weeks exercises treatment program.It is a self-report questionnaire.Twenty questions that assesses a person's capacity doing twenty different everyday activities.Patients select an answer from the following scale for each activity listed: Extreme difficulty. Quite a bit of difficulty. Moderate difficulty. A little bit of difficulty. No difficulty. Scoring guidelines to determine the final score,the scale's columns are added together, thus, the maximum possible score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low function.While 9 scale points are the smallest difference that may be seen and the smallest variation that is clinically significant.Percentage of maximum function=(lower extermity function scale score)/80*100. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recreational runners, Frontal plane projection angle, Pelvic drop height, Kinovea software