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Muscle Architecture and Anterior Cruciate Ligament

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Plyometric Exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anterior Cruciate Ligament Injuries focused on measuring biceps femoris, vastus lateralis, muscle architecture, anterior cruciate ligament, plyometric training, action observation, motor imagery, fiber length, pennation angle, muscle thickness, function

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hacettepe ÜniversitesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Plyometric Training Group

Control Group

Arm Description

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.

Volunteers in this group will not participate in any training.

Outcomes

Primary Outcome Measures

Muscle Architecture Change-1
Fiber length of the vastus lateralis and biceps femoris longus muscles
Muscle Architecture Change-2
Pennation angle of the vastus lateralis and biceps femoris longus muscles
Muscle Architecture Change-3
Muscle thickness of the vastus lateralis and biceps femoris longus muscles

Secondary Outcome Measures

Functional Performance Change-1
International knee documentation committee score. (Minimum score: 0 Maximum score: 100. Higher scores mean a better outcome.
Functional Performance Change-2
Single leg jump distance

Full Information

First Posted
December 19, 2020
Last Updated
September 23, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04690127
Brief Title
Muscle Architecture and Anterior Cruciate Ligament
Official Title
The Effects of Plyometric Training on Vastus Lateralis and Biceps Femoris Muscle Architectures in Individuals Undergoing Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
biceps femoris, vastus lateralis, muscle architecture, anterior cruciate ligament, plyometric training, action observation, motor imagery, fiber length, pennation angle, muscle thickness, function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plyometric Training Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Volunteers in this group will not participate in any training.
Intervention Type
Other
Intervention Name(s)
Plyometric Exercise
Intervention Description
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)
Primary Outcome Measure Information:
Title
Muscle Architecture Change-1
Description
Fiber length of the vastus lateralis and biceps femoris longus muscles
Time Frame
Before, at the end of the fourth week and the eighth week
Title
Muscle Architecture Change-2
Description
Pennation angle of the vastus lateralis and biceps femoris longus muscles
Time Frame
Before, at the end of the fourth week and the eighth week
Title
Muscle Architecture Change-3
Description
Muscle thickness of the vastus lateralis and biceps femoris longus muscles
Time Frame
Before, at the end of the fourth week and the eighth week
Secondary Outcome Measure Information:
Title
Functional Performance Change-1
Description
International knee documentation committee score. (Minimum score: 0 Maximum score: 100. Higher scores mean a better outcome.
Time Frame
Before, at the end of the fourth week and the eighth week
Title
Functional Performance Change-2
Description
Single leg jump distance
Time Frame
Before, at the end of the fourth week and the eighth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Murat Emirzeoğlu
Phone
+904623778842
Email
muratemirzeoglu@gmail.com
Facility Information:
Facility Name
Hacettepe Üniversitesi
City
Ankara
State/Province
Türkiye
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murat Emirzeoğlu
Phone
+90 4623778842
Email
muratemirzeoglu@gmail.com
First Name & Middle Initial & Last Name & Degree
Özlem Ülger

12. IPD Sharing Statement

Plan to Share IPD
No

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Muscle Architecture and Anterior Cruciate Ligament

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