Protocol summary
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Study aim
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Comparison of neuromuscular exercises with external focus with therapeutic exercises on reduce pain, Improvem function, kinematic and kinetic in men basketball players with medial tibial stress syndrome
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Design
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Two arm parallel group randomised trial with blinded outcome assessment
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Settings and conduct
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Assessments are in baseline, after 6-week intervention, 3, 6, and 12 months of follow-up by a blind assessor, and variables include pain, function, muscle strength, kinematics, and kinetics. All measurements are performed in the university laboratory.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria included those aged between 18 and 35 years with medial tibial stress syndrome for at least 3 weeks’ exercise, induced pain that is located on the posteromedial border of the tibia, palpation of the posteromedial border of the tibia that produces discomfort, will be diagnosed experience sports medicine. The exclusion criteria will be having a history of tibial fracture, clinical suspicion of chronic compartment syndrome or stress fracture.
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Intervention groups
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In Experimental Group 1 (neuromuscular exercises with external focus) include eight types of exercises, double-leg squat, single-leg squat, lunges (walking), double-leg drop jump, single-leg standing on an unstable plate, sidestep cutting maneuver, single-leg hop for distance, vertical jump, and Countermovement jump.
In Experimental Group 2 (therapeutic exercises), the exercises consisted of 3 stages of release techniques (use of foam roll with focus on lateral gastrocnemius, peroneals, and biceps femoris (short head) muscles), stretching (focusing on gastrocnemius/soleus, and
biceps femoris (short head), is activation (increasing the strength of the muscles of the anterior, posterior tibialis, and medial hamstrings).
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Main outcome variables
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Pain, function, lower limbs muscle strength, kinematics, and kinetics
General information
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Reason for update
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Adding the volume of the true sample and the start and end date of the patient recruitment.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210718051938N1
Registration date:
2021-08-01, 1400/05/10
Registration timing:
prospective
Last update:
2023-05-27, 1402/03/06
Update count:
2
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Registration date
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2021-08-01, 1400/05/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-08-09, 1400/05/18
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Expected recruitment end date
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2021-09-16, 1400/06/25
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Actual recruitment start date
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2021-08-11, 1400/05/20
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Actual recruitment end date
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2021-10-30, 1400/08/08
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Trial completion date
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empty
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Scientific title
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Neuromuscular training program for treatment of male basketball players with medial tibial stress syndrome: emphasis on attentional focus and external cues in functional movement training.
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Public title
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Effect of neuromuscular training on improving medial tibial stress syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Male basketball players between 18 and 35 years ages
For at least 3 weeks’ exercise, induced pain located on the posteromedial border of the tibia, palpation of the posteromedial border of the tibia that produces discomfort, will be diagnosed by experienced sports medicine.
Exclusion criteria:
Having a history of tibial fracture
Clinical suspicion of chronic compartment syndrome or stress fracture
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Age
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From 18 years old to 35 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
72
Actual sample size reached:
78
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Following the baseline examination, by using the method on the website http://randomizer.org participants are randomly assigned into the two experimental groups (neuromuscular training with an attentional focus), (therapeutic exercise), and control group. Simple randomization is used. Concealed allocation is performed using a computer generated block randomized table of numbers ( 1 and 2 for experimental groups and 3 for control group) created before the start of data collection by researcher who is not involved in the recruitment or treatment of patients. Then, the random numerical sequence is placed in sealed opaque envelope and processed with treatment according to the group assignment. A blinded outcome assessor who does not know the hypothesis and study methods, measures outcome at baseline, 6 weeks post-intervention, and 12 weeks follow-up.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, the outcome assessor was blind to the process of randomization and assignment of individuals into two experimental groups and control group.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-21, 1400/03/31
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Ethics committee reference number
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IR.SSRC.REC.1400.053
Health conditions studied
1
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Description of health condition studied
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Medial tibial stress syndrome
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ICD-10 code
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S86.89
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ICD-10 code description
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Other injury of other muscles and tendons at lower leg level
Primary outcomes
1
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Description
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Pain
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Timepoint
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Baseline, 6 weeks after intervention, 3, 6, and 12 months follow up
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Method of measurement
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How to measure a variable is using Visual Analogue Scale
Secondary outcomes
1
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Description
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Function
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Timepoint
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Baseline, 6 weeks after intervention, 3, 6, and 12 months follow up
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Method of measurement
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How to measure a variable is using vertical jump
2
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Description
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Muscle strength
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Timepoint
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Baseline, 6 weeks after intervention, 3, 6, and 12 months follow up
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Method of measurement
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How to measure a variable is using Biodex System isokinetic.
3
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Description
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Kinematic
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Timepoint
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Baseline, 6 weeks after intervention, 3, 6, and 12 months follow up
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Method of measurement
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How to measure a variable is using Visual3D software (C-motion Inc, Germantown).
4
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Description
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Kinetic, Tibia acceleration and Time to Stabilization
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Timepoint
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Baseline, 6 weeks after intervention, 3, 6, and 12 months follow up
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Method of measurement
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How to measure a variable is using Two three-axis force plates (AMTI model) in vertical, anterior-posterior, and medial-lateral.
Intervention groups
1
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Description
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First intervention group: Benjaminse et al. (2015) training protocol will be used for the first intervention group. These exercises include eight different types of exercises, in each of which the feedback and verbal training appropriate to that exercise is given to the subjects before the exercise and also during the exercise. People will receive the necessary feedback during practice and will perform well. Feedback exercises include eight types of exercises,double-leg squat, single-leg squat, lunges (walking), double-leg drop jump, single-leg standing on an unstable plate, sidestep cutting maneuver, single-leg hop for distance, vertical jump, and Countermovement jump. During the exercises, the feedback instructions verbally and visually, using learning strategies, applied external attention to the subjects, and influenced their movements during the exercise. For example, in order to perform single-leg squat movements, subjects are asked to stand in front of a conical obstacle and slowly bend their legs in the direction of the cone while descending and bending their knees, focusing on the cone. External focus).
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Category
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Rehabilitation
2
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Description
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Second intervention group: Second intervention group: Exercises include 3 stages of release, stretching, and activation techniques. The subject is asked to participate in the main exercise program after warm-up, which includes release, stretching, and activation exercises. In the first phase, people will use release exercises using a foam roll focusing on the lateral gastrocnemius, peroneals, and biceps femoris (short head) muscles. Exercises with two high intensities (maximum pain tolerance) are performed in 30 seconds or low intensity (minimum pain tolerance) in 90 seconds. Stretching phase exercises are performed focusing on the gastrocnemius/soleus, and biceps femoris (short head). The intensity and volume of the exercises include 3 sets of 30 seconds. The third phase, the activation phase, will focus on increasing the strength of the anterior, posterior tibialis, and medial hamstring muscles. These exercises are performed with 10 to 15 repetitions and each repetition includes 1 to 2 seconds, maintaining isometric contraction at the end of the range of motion and 4 seconds maintaining extroverted contraction.
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Category
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Rehabilitation
3
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Description
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Control group: The control group will not receive any intervention and will perform their routine (basketball) exercises.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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No governmental fund has been received for this study, and it is conducted by researchers.
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Only data related to demographic and outcomes information is shared.
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When the data will become available and for how long
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After publishing the article / articles extracted from the study.
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To whom data/document is available
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The data can be displayed and shared at the reasonable request of the Iranian Clinical Trial Registration Center, journals and university individuals / researchers who are conducting research and scientific activities in this field.
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Under which criteria data/document could be used
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Data analysis and use of documents can only be done provided that their results are presented in systematic review articles conducted by researchers and academic researchers. Necessary conditions for sending data and documents include: 1. Sending an email (preferably with valid university addresses) to one of the researchers of the study. 2. A brief and logical explanation of how to use the data or documents. 3. Ensuring the registration of the protocol Systematic review studies that have requested access to data or documentation.
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From where data/document is obtainable
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Through requesting from Mojtaba Jahanshahi: Mojtaba-jahanshahi@yahoo.com
Amir Letafatkar: letafatkaramir@yahoo.com
Robert baker: rb415@comcast.net
Michael Fredericson: mfred2@stanford.edu
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What processes are involved for a request to access data/document
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The applicant can request details from the researchers within 7 to 14 days using the message sent by email.
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Comments
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