An interventional study of Arm A - blood flow restriction training and Arm B - standard of care in Anterior Cruciate Ligament (ACL) Tear and Physical Therapy, sponsored by Brian W. Noehren. Completed at 2 sites in United States. Open to participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Brian W. Noehren · Not applicable, Interventional, and Treatment
Among 60 studies in Lacerations with a site in United States — 12 open to participants now, 14 under way, 1 of them phase 3. Lacerations · United States.
Among the 60 studies in Lacerations with a site in United States, this one is the 24th largest by enrollment of the 52 interventional ones, is one of 5 that started in 2017, is one of 33 with no phase, and was the 30th registered.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's enrollment of 55 is below the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →12 of the 60 studies in Lacerations with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 27 Lacerations studies recruiting now, 15 (56%) set no upper age limit and 10 (37%) stop at 75 or younger; 6 take children under 18; 9 take healthy volunteers.
This study: 15 Years to 40 Years · all sexes · no healthy volunteers.
The full table on the hub →60 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 5 started in 2017.
Median enrollment 52 across the 52 interventional studies, 50 across the 7 observational. Of the 36 that completed or were terminated, 18 (50%) have results posted.
8 of 60 have an industry lead sponsor. The 10 most frequent:
Brian W. Noehren is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Brian W. Noehren has 1 study filed under Lacerations — fewer than ten, so there is no comparison to draw.
6 of the studies in Lacerations with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06910241Phase 3Florida Atlantic UniversityLidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs | 2027-06-30 |
| NCT07606625University of California, BerkeleyOcular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment | 2026-12-31 |
| NCT07068880Brett LewellynClinical Analysis of a Novel Flexor Tendon Repair Technique | 2027-01 |
| NCT07632183Edward Via Virginia College of Osteopathic MedicineWill a Hands on Technique Applied to the Face Increase the Tear Production in Participants | 2027-06 |
| NCT07688967Arthroresearch LLCMeasuring Knee Laxity and Pivot Shift in ACL-Deficient Patients | 2027-07 |
Among the 60 studies in Lacerations with a site in United States, from their registry updates:
The purpose of the study is to determine how two different blood flow restriction training programs used in conjunction with standard rehabilitation affect leg strength. By doing this study, the investigator hopes to learn if one program improves strength and function more than the other. The investigator also hope to learn how the training affects the properties of muscle in participants who will or have had anterior cruciate ligament (ACL) reconstruction. These results will help define how the training programs are working.
There will be no charge to the participant for their physical therapy visits as long as they are part of the study
The initial visit and follow up assessment at the end of the training will each take up to 6 hours (2 hours for MRI, 2 muscle biopsy, 2 for muscle strength, movement mechanics and questionaires).
The physical therapy visits will range from 60-120 minutes depending on the participant's stage of recovery and the activities to engage in. Training sessions will be held 3 days a week for approximately 4 weeks before surgery and up to 24 weeks after surgery. There will be a total of 4 additional study visits over a 7 month period. The first visit will be used to capture baseline conditions of their knee and thigh muscles (muscle biopsy, MRI, strength). The second visit will occur right before surgery to assess changes during prehabilitation (strength and walking mechanics). The third visit will occur 4-5 months after surgery and will be a complete reevaluation of their thigh muscle and knee function (muscle biopsy, MRI, strength, gait). The last visit will occur 6-7 months after surgery and will involve an assessment of their thigh muscle strength, walking, and jumping form.
The muscle biopsy and magnetic resonance imaging portion of the study will occur in the outpatient unit of the Center for Clinical and Translational Science at the UK Medical Center and the MRI center located on the medical center campus. The muscle biopsy will take an additional 15 minutes and the MRI up to two hours (1 hour per leg). It can take up to 4 hours total to complete both procedures. The investigator will accommodate participant preference for scheduling.
The following procedures may be performed.
Training sessions: Participants will be randomly assigned one of two groups. Assignments to which group are determined by random assignment based upon participant's number. One group will receive standard of care and the other will receive standard of care plus blood flow restriction training.
The air bands will then be placed on the participant's thighs and they will be doing a standardized exercise program that will vary depending on the stage of rehabilitation they are in and as determined by the study personnel. Participants will also complete a standardized course of physical therapy. Activities in physical therapy may include ice over the knee, range of motion exercises to maintain hip strength and gait training exercises as needed and as the participant's impairments dictate. The investigator will also provide an educational program at regular intervals on the injury and recovery.
Quadriceps strength: Participants will sit in a seated position and a stabilizing strap will be placed around the thigh. A second strap will be placed around the bottom of their lower leg and attached to the isokinetic dynamometer (a muscle strength testing device) which will control movements and apply force at several different speeds and in a isometric mode.
Motion Analysis: Motion analysis will provide a means for evaluating motion of the participant's hip, knee and ankle joints during walking and jogging on the treadmill. Participants will have reflective markers placed on certain landmarks of their legs and lower back to allow the motion analysis system to record their trunk, hip, knee, and ankle movements. Markers will be applied with sticky tape to the skin and if necessary, athletic tape to limit marker movement during activities. A stationary trial will be collected to help the researcher identify anatomical landmarks. Motion data will be collected for 10 seconds every minute. Participants will perform a series of jumps on both legs and on a single leg. In addition participants will be asked to go up and down step.
Treadmill Activity: Participants may walk on the treadmill as long as necessary to feel comfortable with it. Once ready, participants will walk at a self-selected warm up pace for 5 minutes. The investigator will then gradually increase the speed 1.5 m/s for 2 minutes each. The speed of the treadmill will then be increased gradually to a self-selected comfortable jogging\running pace for 2 minutes. Participants may request to stop at any time.
Muscle Biopsy: A small piece of muscle tissue will be removed from both of thighs. The muscle tissue will be taken from the outside of your thigh and will be taken about one hand width above your knee. A 1 inch by 1 inch portion of hair will possibly need to be shaved if necessary. The area of thigh will be numbed and a small ¼ inch incision will be made in the skin. A needle will then be briefly (lasting just a couple of seconds) inserted into the muscle to remove a .005 ounce piece of muscle (about the size of a pencil eraser). The incision will be pulled closed with a band-aid after the site is cleaned with an alcohol preparation and the participant's leg will be wrapped snugly with an elastic bandage. The procedure will last approximately 15 minutes. The tissue samples will be used in the analysis process. In addition, standard venipuncture methods will be used to collect one 7.5 mL tube of blood to be used for analysis.
Magnetic Resonance Imaging \& Spectroscopy Center: Participants will be asked to complete a medical screening questionnaire that will ask specific questions about their health and medical history. This information will be used to determine eligibility to participate in the study. At this time, the procedures and risks involved in participating in the research study will be explained to the individual. Participants will also fill out a questionnaire asking whether they have any metal in their body as well as any other medical conditions that may need to be considered before they enter the MRI scanner. The metal screening questionnaire will be reviewed by the individual operating the scanner and if any risks are identified, the participant may not be able to participate.
Participants will be taken to the MRI scanner by the experimenter. Participants will be asked to remove all jewelry, body piercings, hair accessories, belts, wallets, credit cards, and loose change and leave these items with the experimenter. Participants will then be instructed about specific MRI procedures.
The magnetic resonance scanning will take approximately 60 minutes per leg. Participants will be asked to lie still during the scanning.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group will use blood flow restriction training and standard of care
Other: Arm A - blood flow restriction training
Group will receive standard of care plus a sham version of blood flow restriction training
Other: Arm B - standard of care
Group receive standard of care plus blood flow restriction training
Group will receive standard of care plus a sham version of blood flow restriction training
Measure Change in Isometric Peak Torque Quadriceps Strength
Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time frame: Baseline, and post-surgery (up to 5 months)
Measure Change in Isokinetic Peak Torque Quadriceps Strength
Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time frame: Baseline and post-surgery (up to 5 months)
Measure Change in Rate of Torque Development
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time frame: Baseline and post-surgery (up to 5 months)
Measure Change in Quadriceps Muscle Morphology - T1Rho Relaxation Time
MRI will be used. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time frame: Baseline, Post-surgery (up to 5 months)
Measure Change in Quadriceps Muscle Morphology - Physiological Cross-sectional Area (PCSA)
MRI will be used. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time frame: Baseline, Post-surgery (up to 5 months)
Measure Change in Knee Biomechanics - Peak Knee Flexion
3D Motion Capture will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time frame: Baseline and post-surgery (up to 5 months)
Measure Change in Knee Biomechanics - Knee Extensor Moment (KEM)
3D Motion Capture will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time frame: Baseline and post-surgery (up to 5 months)
Measure the Change in Muscle Physiology After Using BFRT for Treatment in Patients Who Will Have an ACL Reconstruction.
Muscle biopsy, which may include immunohistochemistry, histochemistry, protein expression, gene expression, or single fiber morphology may be measured. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time frame: Before surgery, 4 months after surgery
Participants were recruited from the Department of Orthopaedic Surgery \& Sports Medicine at the University of Kentucky and were scheduled to undergo surgical reconstruction by one of three orthopedic surgeons.
| Milestone | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham |
|---|---|---|
| Started | 26 | 26 |
| Completed | 23 | 25 |
| Not completed | 3 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 |
Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
| Nm/Kg | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham |
|---|---|---|
| Baseline | 2.18 ± 0.66 | 2.06 ± 0.65 |
| Post-surgery | 1.96 ± 0.59 | 1.95 ± 0.57 |
Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
| Nm/kg | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham |
|---|---|---|
| Baseline | 1.03 ± 0.35 | 1.00 ± 0.41 |
| Post-surgery | 1.13 ± 0.33 | 1.09 ± 0.38 |
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
| Nm/kg/s | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham |
|---|---|---|
| Baseline | 7.10 ± 3.46 | 6.35 ± 3.14 |
| Post-surgery | 5.51 ± 2.79 | 4.68 ± 2.37 |
MRI will be used. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
| milliseconds | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham |
|---|---|---|
| Baseline | 0.029 ± 0.003 | 0.031 ± 0.004 |
| Post-surgery | 0.030 ± 0.002 | 0.029 ± 0.002 |
MRI will be used. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
| mm2 | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham |
|---|---|---|
| Baseline | 6238.7 ± 1783.0 | 6290.9 ± 1942.5 |
| Post-surgery | 6626.0 ± 2484.6 | 6386.6 ± 1862.2 |
3D Motion Capture will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
| degrees | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham |
|---|---|---|
| Baseline | 21.51 ± 4.66 | 22.50 ± 4.42 |
| Post-surgery | 16.87 ± 8.05 | 16.63 ± 4.76 |
Muscle biopsy, which may include immunohistochemistry, histochemistry, protein expression, gene expression, or single fiber morphology may be measured. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Results for this outcome have not been posted.
3D Motion Capture will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
| (Nm/(kg*m) | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham |
|---|---|---|
| Baseline | 0.16 ± 0.11 | 0.19 ± 0.12 |
| Post-surgery | 0.16 ± 0.16 | 0.13 ± 0.14 |
Collected over 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A - Blood Flow Restriction Training | 0/23 (0%) | 1/23 (4.3%) | 0/23 (0%) |
| Arm B - Standard of Care Plus Sham | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Event | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham |
|---|---|---|
| Patellar FractureMusculoskeletal and connective tissue disorders | 1/23 | 0/25 |
| Age, Continuous(years) | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham | Total |
|---|---|---|---|
| Mean | 20.8 ± 6.0 | 21.2 ± 5.3 | 21.0 ± 5.7 |
| Sex: Female, Male(Participants) | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 15 | 15 | 30 |
| Race and Ethnicity Not Collected(Participants) | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham | Total |
|---|---|---|---|
| United States | 26 | 26 | 52 |
| Body Mass Index(kg/m2) | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham | Total |
|---|---|---|---|
| Mean | 25.3 ± 4.2 | 25.7 ± 4.4 | 25.4 ± 4.5 |
| Time since injury(Days) | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham | Total |
|---|---|---|---|
| Mean | 20.2 ± 16.5 | 24.3 ± 16.7 | 22.3 ± 16.9 |
| Graft Type(Participants) | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham | Total |
|---|---|---|---|
| Patellar | 24 | 24 | 48 |
| Hamstring | 1 | 2 | 3 |
| Unknown (lost to follow up before surgery) | 1 | 0 | 1 |
| Meniscal Injury(Participants) | Arm A - Blood Flow Restriction Training | Arm B - Standard of Care Plus Sham | Total |
|---|---|---|---|
| Lateral | 1 | 4 | 5 |
| Medial | 7 | 6 | 13 |
| Both | 16 | 14 | 30 |
| None | 1 | 2 | 3 |
| Unknown (lost to follow up before surgery) | 1 | 0 | 1 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2017 to primary completion in Oct 2023, 73 months.
Results were first posted in Dec 2024, 1 year 1 month after primary completion.
Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's 73 months is above that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Brian W. Noehren