Anterior Cruciate Ligament InjuryNCT02148172
Optimizing Plyometric Training for Functional Recovery Post-ACL Reconstruction
A study testing Standard Plyometric Training and Plyometric Training with BWS in people with Anterior Cruciate Ligament Injury and Knee Injury, run by University of Montana at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Knee Injury
- What is being tested?
- Standard Plyometric Training and Plyometric Training with BWS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Montana, Movement Science Laboratory
Missoula, Montana, 59812
About this study
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.
- Conditions
- Anterior Cruciate Ligament Injury, Knee Injury
- Being tested
- Standard Plyometric Training, Plyometric Training with BWS
- Keywords
- Knee, plyometrics, motor learning, psychological factors
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Plyometric TrainingProcedure or surgery
Participants will undergo individualized practice exercises of jumping, hopping, and cutting tasks consistent with standard published exercises.
Plyometric Training with BWSProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Plyometric Training | Active comparator | 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. Receives: Procedure: Standard Plyometric Training |
| Plyometric Training with BWS | Experimental | 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. Receives: Procedure: Plyometric Training with BWS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sagittal plane knee kinetics and kinematics
Measured: Baseline and after 8 weeks of training
Change in psychological readiness for sports activities via survey scores
Measured: baseline and after 8 weeks of training
Change in motor patterning via electromyography of quadriceps and hamstring muscles
Measured: Baseline and after 8 weeks of training
Secondary outcomes (3)
Retention of Biomechanical Adaptions in Knee kinetics and kinematics
Measured: Change from end of 8 weeks of training to 2 month follow-up
Retention of adaptations in Psychological Readiness for Sport via survey
Measured: Change from end of 8 weeks of training to 2 month follow-up
Retention of adaptations in motor patterning via electromyography
Measured: Change from end of 8 weeks of training to 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc., American Physical Therapy Association
- Responsible party
- Principal investigator, Ryan Mizner, University of Montana
- Investigators
- Ryan L Mizner, PT, PhD, Principal investigator, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148172
- Sponsor's protocol ID
- UM IRB 282-13
- Status last verified
- Apr 2019
- First submitted
- 22 May 2014
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Elias ARC, Harris KJ, LaStayo PC, Mizner RL. Clinical Efficacy of Jump Training Augmented With Body Weight Support After ACL Reconstruction: A Randomized Controlled Trial. Am J Sports Med. 2018 Jun;46(7):1650-1660. doi: 10.1177/0363546518759052. Epub 2018 Mar 20.
PubMed 29558161
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Plyometric Training for Functional Recovery Post-ACL Reconstruction
- ClinicalTrials.gov ID
- NCT02148172
- Acronym / sponsor ID
- UM IRB 282-13
- Conditions
- Anterior Cruciate Ligament Injury, Knee Injury
- Keywords
- Knee, plyometrics, motor learning, psychological factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc., American Physical Therapy Association
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Plyometric Training | Active comparator | Procedure: Standard Plyometric TrainingParticipants 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. |
| Plyometric Training with BWS | Experimental | Procedure: Plyometric Training with BWSParticipants 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. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Plyometric TrainingParticipants will undergo individualized practice exercises of jumping, hopping, and cutting tasks consistent with standard published exercises. | Procedure or surgery | Standard Plyometric Training |
| Plyometric Training with BWSParticipants 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. | Procedure or surgery | Plyometric Training with BWS |
Primary outcome
Change in sagittal plane knee kinetics and kinematics
Time frame: 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
Change in motor patterning via electromyography of quadriceps and hamstring muscles
Time frame: Baseline and after 8 weeks of training
3 secondary outcomes
Retention of Biomechanical Adaptions in Knee kinetics and kinematics
Time frame: 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
Retention of adaptations in motor patterning via electromyography
Time frame: Change from end of 8 weeks of training to 2 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Derived from this study: PubMed 29558161Elias ARC, Harris KJ, LaStayo PC, Mizner RL. Clinical Efficacy of Jump Training Augmented With Body Weight Support After ACL Reconstruction: A Randomized Controlled Trial. Am J Sports Med. 2018 Jun;46(7):1650-1660. doi: 10.1177/0363546518759052. Epub 2018 Mar 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan L Mizner, PT, PhD principal investigator
University of Montana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Plyometric Training and Plyometric Training with BWS in people with Anterior Cruciate Ligament Injury and Knee Injury, run by University of Montana at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sagittal plane knee kinetics and kinematics (time frame: Baseline and after 8 weeks of training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02148172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.