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

Primary Purpose

Medial Tibial Stress Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Functional strength training of hip abductors
A selected physical therapy exercise program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Medial Tibial Stress Syndrome focused on measuring Recreational runners, Frontal plane projection angle, Pelvic drop height, Kinovea software

Eligibility Criteria

25 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A (Active control group)

Group B (Experimental group)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
November 13, 2022
Last Updated
February 19, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05637476
Brief Title
Effect of Functional Strength Training of Hip Abductors in Runners With Medial Tibial Stress Syndrome
Acronym
MTSS
Official Title
Effect of Functional Strength Training of Hip Abductors in Runners With Medial Tibial Stress :(Randomised Clinical Trail)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Tibial Stress Syndrome
Keywords
Recreational runners, Frontal plane projection angle, Pelvic drop height, Kinovea software

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Active control group)
Arm Type
Active Comparator
Arm Description
Group A (number=20): which is the control group with medial tibial stress syndrome, they will receive a selected physical therapy exercise program.
Arm Title
Group B (Experimental group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Functional strength training of hip abductors
Intervention Description
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 .
Intervention Type
Other
Intervention Name(s)
A selected physical therapy exercise program
Other Intervention Name(s)
Common established treatment exercises
Intervention Description
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)
Primary Outcome Measure Information:
Title
The Frontal Plane Projection Angle
Description
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).
Time Frame
Change from baseline frontal plane projection angle at 8 weeks.
Title
The contra-lateral pelvic drop angle
Description
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.
Time Frame
Change from baseline contra-lateral pelvic drop angle at 8 weeks.
Secondary Outcome Measure Information:
Title
Pain severity
Description
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
Time Frame
8 weeks
Title
Lower extremity function
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shreen Ahmed Lashien, Master
Phone
01090913270
Email
lasheensh2020@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed O Abdelnaeem, Doctorate
Phone
01140736820
Email
ahmed.omar@pt.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebtessam F Gomaa, Doctorate
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopedic out clinic of the faculty of Physical therapy, Cairo, University,and Gezira Youth Center.
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Effect of Functional Strength Training of Hip Abductors in Runners With Medial Tibial Stress Syndrome

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