ACL TearsNCT03132987
Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction
A study testing Progressive strengthening program in people with ACL Tears, run by Creighton University at 1 site in United States.
Trial summary
Quantify differences in quadriceps function and gait biomechanics in individuals within 2 years of ACL reconstruction compared to a healthy comparison group and establish the feasibility of conducting a progressive strengthening program to improve clinical and patient-oriented outcomes in individuals who are within 2… Read more about this study
- Who is it for?
- Ages 14 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Tears
- What is being tested?
- Progressive strengthening program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 31 Jul 2017
- 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 14 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Physically active
- History of primary unilateral ACL reconstruction within the past 3-24 months (ACL group only)
Who cannot join
- History of lumbar spine or lower extremity injury or surgery (except ACL) within the past 1 year that required physician care
- Concomitant knee injury (ACL group only): ligament injury that requires surgical repair (medial collateral ligament [MCL], posterior cruciate ligament[PCL]), chondral defects >2cm, fracture, bilateral knee injury
- Medial conditions that are contraindications to electrical stimulation: Cardiac Pacemaker and Pregnancy
- Participants who are unable to understand procedures of experiment or provide consent (assent/parental permission)
Trial locations and contacts
1 site in 1 country.
About this study
Quantify differences in quadriceps function and gait biomechanics in individuals within 2 years of ACL reconstruction compared to a healthy comparison group and establish the feasibility of conducting a progressive strengthening program to improve clinical and patient-oriented outcomes in individuals who are within 2 years of ACL reconstruction
Read the detailed description
A maximal isometric muscle contraction of the quadriceps will be used to examine neural and peripheral contributions to quadriceps strength. Neural influences will be quantified using the interpolated twitch technique (voluntary activation) and early RTD. Peripheral influences will be quantified by examining the stimulus-evoked torque with the quadriceps relaxed (resting twitch) and late RTD. Knee joint biomechanics during treadmill walking and running will include sagittal plane (flexion, extension) movement variability (Lyapunov Exponent and approximate entropy), peak knee flexion angle, and peak external knee flexion and adduction moments. Additionally, the clinical relevance of impairments in the ACL reconstruction group will be determined by examining the relationship with performance on jumping tasks and patient function (secondary outcomes).
The progressive strengthening program will be performed for 6 weeks and emphasize development of strength and power. Feasibility will be established if the researchers can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. The researchers will determine effect sizes for changes outcome measures.
- Conditions
- ACL Tears
- Being tested
- Progressive strengthening program
- Keywords
- quadriceps strength, quadriceps voluntary activation, progressive strength program
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive strengthening programOther
The progressive strengthening program will be performed for 3 weeks and emphasize development of strength and power. Feasibility will be established if we can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. We will determine effect sizes for changes outcome measures.
| Study group | Role | What they receive |
|---|---|---|
| Progressive strengthening program | Experimental | Subjects identified as having a clinically relevant strength deficit will be asked to participate in physical therapy sessions 3 times per week for 3 weeks. The strengthening program will consist of an individualized, progressive exercise program with an emphasis on increasing lower extremity strength, power, and biomechanics. Receives: Other: Progressive strengthening program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Rate of Torque Development (RTD) Maximum
slope of the torque-time tracing (change in torque/change in time) (Nm/kg*s-1)
Measured: Change from Baseline Quadriceps RTD at 3 weeks
Knee Joint biomechanics during gait (nonlinear)
Sagittal plane (knee flexion) movement variability (calculated using Lyapunov Exponent and approximate entropy)
Measured: Change from Baseline nonlinear knee joint biomechanics at 3 weeks
Secondary outcomes (4)
Quadriceps percent activation
Supramaximal electrical stimulus (interpolated twitch technique) used to augment a voluntary muscle contraction
Measured: Change from Baseline Quadriceps percent activation at 3 weeks
Knee Joint biomechanics during gait (traditional)
peak external knee flexion moment (Nm/kgm)
Measured: Change from Baseline knee joint biomechanics at 3 weeks
Patient reported function
International Knee Documentation Committee (IKDC) subjective form
Measured: Change from Baseline IKDC at 3 weeks
Jumping performance
single leg hop for distance (cm)
Measured: Change from Baseline single leg hop for distance at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study startJan 2017
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Physical therapy exercises (progressive strengthening program)
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska, National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Terry L Grindstaff, PhD, PT, ATC, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132987
- Sponsor's protocol ID
- 928791
- Other IDs
- 5P20GM109090-03
- Status last verified
- Aug 2017
- First submitted
- 30 Jan 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction
- ClinicalTrials.gov ID
- NCT03132987
- Acronym / sponsor ID
- 928791
- Conditions
- ACL Tears
- Keywords
- quadriceps strength, quadriceps voluntary activation, progressive strength program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- University of Nebraska, National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 28 Apr 2017 (actual)
- 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.
Quantify differences in quadriceps function and gait biomechanics in individuals within 2 years of ACL reconstruction compared to a healthy comparison group and establish the feasibility of conducting a progressive strengthening program to improve clinical and patient-oriented outcomes in individuals who are within 2 years of ACL reconstruction
Detailed description
A maximal isometric muscle contraction of the quadriceps will be used to examine neural and peripheral contributions to quadriceps strength. Neural influences will be quantified using the interpolated twitch technique (voluntary activation) and early RTD. Peripheral influences will be quantified by examining the stimulus-evoked torque with the quadriceps relaxed (resting twitch) and late RTD. Knee joint biomechanics during treadmill walking and running will include sagittal plane (flexion, extension) movement variability (Lyapunov Exponent and approximate entropy), peak knee flexion angle, and peak external knee flexion and adduction moments. Additionally, the clinical relevance of impairments in the ACL reconstruction group will be determined by examining the relationship with performance on jumping tasks and patient function (secondary outcomes).
The progressive strengthening program will be performed for 6 weeks and emphasize development of strength and power. Feasibility will be established if the researchers can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. The researchers will determine effect sizes for changes outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Physical therapy exercises (progressive strengthening program)
| Arm | Type | Receives |
|---|---|---|
| Progressive strengthening program | Experimental | Other: Progressive strengthening programSubjects identified as having a clinically relevant strength deficit will be asked to participate in physical therapy sessions 3 times per week for 3 weeks. The strengthening program will consist of an individualized, progressive exercise program with an emphasis on increasing lower extremity strength, power, and biomechanics. |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Physically active
- History of primary unilateral ACL reconstruction within the past 3-24 months (ACL group only)
Key exclusion criteria (4 listed)
- History of lumbar spine or lower extremity injury or surgery (except ACL) within the past 1 year that required physician care
- Concomitant knee injury (ACL group only): ligament injury that requires surgical repair (medial collateral ligament [MCL], posterior cruciate ligament[PCL]), chondral defects >2cm, fracture, bilateral knee injury
- Medial conditions that are contraindications to electrical stimulation: Cardiac Pacemaker and Pregnancy
- Participants who are unable to understand procedures of experiment or provide consent (assent/parental permission)
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 |
|---|---|---|
| Progressive strengthening programThe progressive strengthening program will be performed for 3 weeks and emphasize development of strength and power. Feasibility will be established if we can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. We will determine effect sizes for changes outcome measures. | Other | Progressive strengthening program |
Primary outcome
Quadriceps Rate of Torque Development (RTD) Maximum
Time frame: Change from Baseline Quadriceps RTD at 3 weeks
slope of the torque-time tracing (change in torque/change in time) (Nm/kg*s-1)
Knee Joint biomechanics during gait (nonlinear)
Time frame: Change from Baseline nonlinear knee joint biomechanics at 3 weeks
Sagittal plane (knee flexion) movement variability (calculated using Lyapunov Exponent and approximate entropy)
4 secondary outcomes
Quadriceps percent activation
Time frame: Change from Baseline Quadriceps percent activation at 3 weeks
Knee Joint biomechanics during gait (traditional)
Time frame: Change from Baseline knee joint biomechanics at 3 weeks
Patient reported function
Time frame: Change from Baseline IKDC at 3 weeks
Jumping performance
Time frame: Change from Baseline single leg hop for distance at 3 weeks
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 17 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for ACL Tears
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Quadriceps Strengthening ACL Reconstruction
ACL Tear
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.
Terry L Grindstaff, PhD, PT, ATC principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive strengthening program in people with ACL Tears, run by Creighton University 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 2 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 17 Aug 2017. 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?
Quadriceps Rate of Torque Development (RTD) Maximum (time frame: Change from Baseline Quadriceps RTD at 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2017.