Optimizing Plyometric Training for Functional Recovery Post-ACL Reconstruction

April 24, 2019 updated by: Ryan Mizner, University of Montana

While surgical anterior cruciate ligament reconstruction (ACLR) of the knee restores passive stability, studies are showing consistently poor long-term outcomes. Unusually high risks of early-onset osteoarthritis and re-injury, and low rate of return to sport following ACLR all seem to be related to a chronic tendency to land stiff-legged from a jump or hop, which itself may be due to fear of re-injury. Decreased knee bending for force absorption simultaneously decreases performance level and increases risk for injury and arthritic changes.

The purpose of the proposed study is to compare a current best-practice plyometric training program to one utilizing body weight support to increase repetition and improve performance in the initial phases. The investigators hypothesize that we will see larger improvements in absorptive capacity of the knee and better confidence in activity immediately following body weight support training, as well as improved retention of training effects after a two-month period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • Montana
      • Missoula, Montana, United States, 59812
        • University of Montana, Movement Science Laboratory

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • speak and understand English
  • age between 12-35 years
  • unilateral anterior cruciate ligament reconstruction between 6-48 months prior
  • activity level greater than or equal to level 5 on the Tegner Activity Scale

Exclusion Criteria:

  • Weight in excess of 300 pounds (136 kg)
  • contralateral/bilateral ACL reconstruction or an unreconstructed ACL injury
  • history of a posterior cruciate ligament injury
  • lower extremity of back injury or other condition (e.g. cerebral palsy) that has limited their normal activities of daily living within the last 6 months

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Plyometric Training
Participants will undergo treatment 2 times a week for 8 weeks with plyometric exercises deemed to be consistent with best practice delivered at a standard dosage of sets and repetitions.
Procedure: Standard Plyometric Training
Participants will undergo individualized practice exercises of jumping, hopping, and cutting tasks consistent with standard published exercises.
Experimental: Plyometric Training with BWS
Participants will undergo treatment 2 times a week for 8 weeks with plyometric exercises deemed to be consistent with best practice with a treatment volume of sets and repetitions that exceeds standard practice. Higher number of practice trials will be completed with body weight support (BWS) to reduce load. Participants will start at 30 percent of body weight and will be slowly weaned away over time.
Procedure: Plyometric Training with BWS
Participants will undergo individualized practice exercises of jumping, hopping, and cutting tasks consistent with standard published exercises while their body weight is supported via adjustable harness.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in sagittal plane knee kinetics and kinematics
Time Frame: Baseline and after 8 weeks of training
Baseline and after 8 weeks of training
Change in psychological readiness for sports activities via survey scores
Time Frame: baseline and after 8 weeks of training
baseline and after 8 weeks of training
Change in motor patterning via electromyography of quadriceps and hamstring muscles
Time Frame: Baseline and after 8 weeks of training
Baseline and after 8 weeks of training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Retention of Biomechanical Adaptions in Knee kinetics and kinematics
Time Frame: Change from end of 8 weeks of training to 2 month follow-up
Change from end of 8 weeks of training to 2 month follow-up
Retention of adaptations in Psychological Readiness for Sport via survey
Time Frame: Change from end of 8 weeks of training to 2 month follow-up
Change from end of 8 weeks of training to 2 month follow-up
Retention of adaptations in motor patterning via electromyography
Time Frame: Change from end of 8 weeks of training to 2 month follow-up
Change from end of 8 weeks of training to 2 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Montana

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Physical Therapy Association
Foundation for Physical Therapy, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ryan L Mizner, PT, PhD, University of Montana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UM IRB 282-13

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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