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

NCT ID: NCT05637476

Last Updated: 2024-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-06-30

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.

Conditions

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Medial Tibial Stress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A (Active control group)

Group A (number=20): which is the control group with medial tibial stress syndrome, they will receive a selected physical therapy exercise program.

Group Type ACTIVE_COMPARATOR

A selected physical therapy exercise program

Intervention Type OTHER

Every participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises:

1. Strength dorsiflexors of the ankle-using rubber band.
2. Eccentric calf exercise (calf raise) .
3. Balance and proprioceptive exercise using wobble boards.
4. Stretch planter flexors (three sets of thirty repetitions, thirty seconds rest in between, three times per week)

Group B (Experimental group)

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.

Group Type EXPERIMENTAL

Functional strength training of hip abductors

Intervention Type OTHER

Every participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises:

1. Pelvic drop.
2. Single leg -bridge.
3. Side-lying hip abduction with hip internal rotation.
4. Lateral step-up.
5. Standing hip abduction on stance or swing leg with extra resistance .

A selected physical therapy exercise program

Intervention Type OTHER

Every participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises:

1. Strength dorsiflexors of the ankle-using rubber band.
2. Eccentric calf exercise (calf raise) .
3. Balance and proprioceptive exercise using wobble boards.
4. Stretch planter flexors (three sets of thirty repetitions, thirty seconds rest in between, three times per week)

Interventions

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Functional strength training of hip abductors

Every participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises:

1. Pelvic drop.
2. Single leg -bridge.
3. Side-lying hip abduction with hip internal rotation.
4. Lateral step-up.
5. Standing hip abduction on stance or swing leg with extra resistance .

Intervention Type OTHER

A selected physical therapy exercise program

Every participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises:

1. Strength dorsiflexors of the ankle-using rubber band.
2. Eccentric calf exercise (calf raise) .
3. Balance and proprioceptive exercise using wobble boards.
4. Stretch planter flexors (three sets of thirty repetitions, thirty seconds rest in between, three times per week)

Intervention Type OTHER

Other Intervention Names

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Common established treatment exercises

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Shreen Lashien

Senior musculoskeletal physiotherapist ,faculty of physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ebtessam F Gomaa, Doctorate

Role: STUDY_CHAIR

Cairo University

Locations

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Orthopedic out clinic of the faculty of Physical therapy, Cairo, University,and Gezira Youth Center.

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Dierks TA, Manal KT, Hamill J, Davis IS. Proximal and distal influences on hip and knee kinematics in runners with patellofemoral pain during a prolonged run. J Orthop Sports Phys Ther. 2008 Aug;38(8):448-56. doi: 10.2519/jospt.2008.2490. Epub 2008 Aug 1.

Reference Type RESULT
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Reference Type RESULT
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Menendez C, Batalla L, Prieto A, Rodriguez MA, Crespo I, Olmedillas H. Medial Tibial Stress Syndrome in Novice and Recreational Runners: A Systematic Review. Int J Environ Res Public Health. 2020 Oct 13;17(20):7457. doi: 10.3390/ijerph17207457.

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Lashien SA, Abdelnaeem AO, Gomaa EF. Effect of hip abductors training on pelvic drop and knee valgus in runners with medial tibial stress syndrome: a randomized controlled trial. J Orthop Surg Res. 2024 Oct 29;19(1):700. doi: 10.1186/s13018-024-05139-3.

Reference Type DERIVED
PMID: 39468623 (View on PubMed)

Other Identifiers

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Medial tibial stress syndrome

Identifier Type: -

Identifier Source: org_study_id

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