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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04690127
Other study ID # 2020-11167
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date August 1, 2023

Study information

Verified date September 2022
Source Hacettepe University
Contact Murat Emirzeoglu
Phone +904623778842
Email muratemirzeoglu@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injuries

Intervention

Other:
Plyometric Exercise
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)

Locations

Country Name City State
Turkey Hacettepe Üniversitesi Ankara Türkiye

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Architecture Change-1 Fiber length of the vastus lateralis and biceps femoris longus muscles Before, at the end of the fourth week and the eighth week
Primary Muscle Architecture Change-2 Pennation angle of the vastus lateralis and biceps femoris longus muscles Before, at the end of the fourth week and the eighth week
Primary Muscle Architecture Change-3 Muscle thickness of the vastus lateralis and biceps femoris longus muscles Before, at the end of the fourth week and the eighth week
Secondary Functional Performance Change-1 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
Secondary Functional Performance Change-2 Single leg jump distance Before, at the end of the fourth week and the eighth week
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