Clinical trial NCT05637476: Effect of Functional Strength Training of Hip Abductors in Runners With Medial Tibial Stress Syndrome
Official title: Effect of Functional Strength Training of Hip Abductors in Runners With Medial Tibial Stress :(Randomised Clinical Trail)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Medial Tibial Stress Syndrome
Keywords: Recreational runners
Frontal plane projection angle
Pelvic drop height
Kinovea software
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Frontal Plane Projection Angle
timeFrame: Change from baseline frontal plane projection angle at 8 weeks.
measure: The contra-lateral pelvic drop angle
timeFrame: Change from baseline contra-lateral pelvic drop angle at 8 weeks.
Secondary outcomes:
measure: Pain severity
timeFrame: 8 weeks
measure: Lower extremity function
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Orthopedic out clinic of the faculty of Physical therapy, Cairo, University,and Gezira Youth Center.
Study officials:
affiliation: Cairo University
name: Ebtessam F Gomaa, Doctorate
role: STUDY_CHAIR
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