- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04690127
Muscle Architecture and Anterior Cruciate Ligament
September 23, 2022 updated by: Murat EMİRZEOĞLU, Hacettepe University
The Effects of Plyometric Training on Vastus Lateralis and Biceps Femoris Muscle Architectures in Individuals Undergoing Anterior Cruciate Ligament Reconstruction
The aim of this study is to examine the effects of plyometric training on biceps femoris longus (BFl) and vastus lateralis (VL) muscle architecture in individuals with anterior cruciate ligament reconstruction (ACLR).
Individuals will be randomly placed into training and control groups.
Measurements of muscle architecture will be taken bilaterally from BFl and VL muscles by means of an ultrasound device.
Functional performance will be evaluated with the International Knee Documentation Committee score and the single leg jump test.
Following the initial evaluations, individuals in the training group will receive plyometric training.
Evaluations of muscle architecture and functional performance will be taken again from the individuals in the training and control groups at the end of the 4th and 8th weeks.
The received ultrasound images will be calculated through the MicroDicom software.
In-group and between-group comparisons will be analyzed using the Statistical Package for the Social Sciences program and appropriate tests.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Anterior cruciate ligament (ACL) injuries are common, especially in young individuals participating in rolling and jumping activities.
After injury, many people undergo ACL reconstruction (ACLR) surgery.
The aim of this study is to examine the effects of plyometric training on biceps femoris longus (BFl) and vastus lateralis (VL) muscle architecture (fiber length, penation angle and muscle thickness) in individuals with ACLR.
Individuals who have undergone ACLR in this study, which is designed as a parallel group randomized controlled study, will be randomly placed into two different groups, the training group and the control group.
Imagery ability, self-efficacy and motivation will be evaluated with various questionnaires and scales in order to compare the homogeneity of the groups.
Measurements of muscle architecture will be taken bilaterally from BFl and VL muscles by means of an ultrasound device.
Functional performance will be evaluated with the International Knee Documentation Committee score and the single leg jump test.
Following the initial evaluations, individuals in the training group will receive plyometric training consisting of ten different exercises for 8 weeks, 3 sessions per week.
In this training, individuals will not participate in a real plyometric training.
Volunteers will watch videos to be prepared (action observation) and imagine them performing those exercises (motor imagery).
Except for one session that will be applied every two weeks, all other trainings will be given on the basis of telerehabilitation via distance education tools.
Cognitive fatigue at the beginning and end of the session; at the end of each session, the technical quality and efficiency of the training will be evaluated.
Evaluations of muscle architecture and functional performance will be taken again from the individuals in the control and training groups at the end of the 4th and 8th weeks.
The received ultrasound images will be calculated through the MicroDicom software.
In-group and between-group comparisons will be analyzed using the Statistical Package for the Social Sciences program and appropriate tests.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Murat Emirzeoğlu
- Phone Number: +904623778842
- Email: muratemirzeoglu@gmail.com
Study Locations
-
-
Türkiye
-
Ankara, Türkiye, Turkey, 06230
- Recruiting
- Hacettepe Universitesi
-
Contact:
- Murat Emirzeoğlu
- Phone Number: +90 4623778842
- Email: muratemirzeoglu@gmail.com
-
Principal Investigator:
- Özlem Ülger
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Volunteers with unilateral anterior cruciate ligament reconstruction (ACLR)
- Volunteers using hamstring autograft in their ACLR
- Volunteers who have passed 1-5 years after their ACLR
Exclusion Criteria:
- Those who underwent same-side meniscus repair other than ACLR
- Those who have had revision surgery
- Those who had posterior cruciate ligament rupture in addition to anterior cruciate ligament
- Third-degree tears in the lateral or medial collateral ligaments
- Those with 2nd or 3rd degree strain injuries in hamstring and quadriceps muscle groups
- Those with a history of congenital, neurological, orthopedic, rheumatologic and cardiopulmonary pathology or anomalies,
- Those with serious systemic diseases
Relative Exclusion Criteria:
- Those with acute infection or pain
- Those with joint instability
- Those with a body mass index of 30 and above
- Those receiving energy supplements or ergogenic assistance during or during the 6-month period prior to work
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Plyometric Training Group
Individuals in the plyometric training group will receive plyometric training.
In this training, individuals will not participate in a real plyometric training.
Volunteers will watch videos to be prepared (action observation) and imagine them performing those exercises (motor imagery).
Except for one session that will be applied every two weeks, all other trainings will be given on the basis of telerehabilitation via distance education tools.
|
Plyometric training consisting of ten different exercises [vertical unilateral and bilateral counter movement jump, horizontal unilateral and bilateral counter movement jump, drop jump (30 cm), squat jump, step-hop (20 cm), 180 degree rotation in transverse plane, frontal plane hurdle jump (20 cm) and sagittal plane hurdle jump (20 cm)] for 8 weeks, 3 sessions per week.
Individuals will not participate in a real plyometric training.
Volunteers will watch videos to be prepared (action observation) and imagine them performing those exercises (motor imagery)
|
No Intervention: Control Group
Volunteers in this group will not participate in any training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Architecture Change-1
Time Frame: Before, at the end of the fourth week and the eighth week
|
Fiber length of the vastus lateralis and biceps femoris longus muscles
|
Before, at the end of the fourth week and the eighth week
|
Muscle Architecture Change-2
Time Frame: Before, at the end of the fourth week and the eighth week
|
Pennation angle of the vastus lateralis and biceps femoris longus muscles
|
Before, at the end of the fourth week and the eighth week
|
Muscle Architecture Change-3
Time Frame: Before, at the end of the fourth week and the eighth week
|
Muscle thickness of the vastus lateralis and biceps femoris longus muscles
|
Before, at the end of the fourth week and the eighth week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Performance Change-1
Time Frame: Before, at the end of the fourth week and the eighth week
|
International knee documentation committee score.
(Minimum score: 0 Maximum score: 100.
Higher scores mean a better outcome.
|
Before, at the end of the fourth week and the eighth week
|
Functional Performance Change-2
Time Frame: Before, at the end of the fourth week and the eighth week
|
Single leg jump distance
|
Before, at the end of the fourth week and the eighth week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
December 19, 2020
First Submitted That Met QC Criteria
December 26, 2020
First Posted (Actual)
December 30, 2020
Study Record Updates
Last Update Posted (Actual)
September 26, 2022
Last Update Submitted That Met QC Criteria
September 23, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-11167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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