Quadriceps Strengthening for Anterior Cruciate Ligament Injury

(ACL Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Bilateral knee injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how strengthening the quadriceps (thigh muscles) can improve knee function after ACL (anterior cruciate ligament) surgery in teenagers. Researchers aim to determine if exercises combined with techniques like NMES (electrical muscle stimulation) and BFR (blood flow restriction) enhance recovery compared to standard rehab exercises alone. This trial suits teens who have undergone ACL surgery without other knee surgeries or injuries. As an unphased trial, it provides a unique opportunity for teens to contribute to innovative recovery methods and potentially enhance their rehabilitation process.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these quadriceps strengthening interventions are safe for adolescents with ACL reconstruction?

Research has shown that both neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR) are safe methods for strengthening thigh muscles after ACL (anterior cruciate ligament) surgery. Studies have found that combining NMES with exercise can enhance thigh muscle strength in the early weeks post-surgery. Reports of serious side effects are absent, making it a generally safe recovery option.

Similarly, BFR effectively prevents muscle loss after ACL surgery. This technique involves temporarily reducing blood flow to the muscles during exercise. Reviews of BFR indicate it aids muscle recovery without significant negative effects.

Overall, both NMES and BFR are well-tolerated by patients and have shown positive results in improving muscle strength after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the quadriceps strengthening techniques being tested because they add new layers to the standard rehabilitation for anterior cruciate ligament (ACL) injuries. Unlike typical rehab, which usually focuses on exercises and physical therapy, this approach includes neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR). NMES helps activate muscles by sending small electrical pulses, enhancing muscle strength early in recovery. Meanwhile, BFR involves reducing blood flow during exercises, which can boost muscle growth and recovery even with less intense workouts. These methods could potentially speed up recovery, offering a more robust and efficient rehabilitation process for ACL injuries.

What evidence suggests that this trial's treatments could be effective for anterior cruciate ligament injury?

Research has shown that using electrical stimulation of muscles (NMES) along with restricting blood flow (BFR) effectively improves muscle function and balance in patients after ACL surgery. In this trial, one group of participants will receive a combination of NMES and BFR in addition to standard rehabilitation. Studies indicate that these methods together help strengthen the quadriceps during recovery. The NMES technique proves particularly helpful in the first few weeks after surgery. By building muscle strength, these methods enhance overall knee function. Overall, evidence suggests that NMES and BFR are promising additions to standard rehabilitation for better recovery outcomes. ^{2 4 6 7 8}

Who Is on the Research Team?

Alexandra M Abbott, MD

Principal Investigator

Stanford School of Medicine

Are You a Good Fit for This Trial?

This trial is for adolescents who have had an ACL reconstruction on one knee and haven't had any previous injuries or surgeries on the other knee. It's not suitable for those with a history of ligament injuries, bilateral knee issues, multiple ligament ruptures, or conditions that make NMES and BFR use unsafe.

Inclusion Criteria

I have never had knee surgery or injury on the opposite leg.

Exclusion Criteria

I have had a previous knee ligament injury or surgery.

I have injuries in both of my knees.

I have multiple torn or ruptured ligaments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week NMES intervention followed by a 10-week BFR intervention, along with standard rehabilitation care

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quadriceps Strengthening

Trial Overview The study compares standard physical therapy to two additional treatments: Neuromuscular Electrical Stimulation (NMES) and Blood Flow Restriction (BFR), focusing on strengthening the quadriceps after ACL surgery in young patients.

How Is the Trial Designed?

Group I: Additional neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR) Experimental Treatment 2 Interventions

Participants receive a 6-week NMES intervention from week 1 to week 6 post-surgery, followed by a 10-week BFR intervention from week 7 to week 16. Participants also receive standard rehabilitation care as part of their routine postsurgical recovery process.

Group II: Standard rehabilitation Active Control 1 Intervention

Participants receive standard rehabilitation care as part of their routine postsurgical recovery process.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9690111/

Effects of Neuromuscular Electrical Stimulation and Blood ... The present study aimed to examine and compare the effects of a rehabilitation exercise (RE) using neuromuscular electrical stimulation (NMES) and blood flow ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X25001588

The effect of blood flow restriction combined with ... The blood flow restriction combined with neuromuscular electrical stimulation had no additional effect to the original isolated techniques on quadriceps ...

3. jospt.org jospt.org/doi/10.2519/jospt.2010.3184

Effects of Neuromuscular Electrical Stimulation After ... The present review supports the use of NMES in conjunction with exercise during the first 4 weeks following ACL reconstruction to improve quadriceps strength.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36429760/

Effects of Neuromuscular Electrical Stimulation and Blood ... In conclusion, we confirmed that RE using NMES and BFR effectively enhances muscle function and balance in ACLR patients. Keywords: anterior ...

5. researchgate.net researchgate.net/publication/365414230_Effects_of_Neuromuscular_Electrical_Stimulation_and_Blood_Flow_Restriction_in_Rehabilitation_after_Anterior_Cruciate_Ligament_Reconstruction

(PDF) Effects of Neuromuscular Electrical Stimulation and ... RE using NMES and BFR effectively enhances muscle function and balance in ACLR patients. Keywords: anterior cruciate ligament reconstruction; ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7727417/

A SYSTEMATIC REVIEW OF THE EFFECTS OF BLOOD ... This review of the available evidence yields promising results regarding the use of BFR and LIRT in the remediation of femoral muscle atrophy after an ACL ...

7. mdpi.com mdpi.com/1660-4601/19/22/15041

Effects of Neuromuscular Electrical Stimulation and Blood ... The present study aimed to examine and compare the effects of a rehabilitation exercise (RE) using neuromuscular electrical stimulation (NMES) and blood flow ...

8. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/126041-biophysics-of-acl-injuries

Biophysics of ACL Injuries This systematic review aims to collate and synthesize the current knowledge surrounding the biophysical mechanisms that underlie ACL injuries.