NMES + ECC for ACL Injury

(MiACLR Trial)

Recruiting at 1 trial location

Overseen By Elizabeth Tropiano

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Previous knee surgery, Knee dislocation, Pregnancy, others

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

129 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates interventions to maximize muscle function and improve cartilage health following anterior cruciate ligament reconstruction. Improving muscle function may improve patient outcomes, improve joint mechanics, and potentially serve as a prevention approach for post-traumatic knee osteoarthritis. Knee osteoarthritis (OA) is a disabling disease that carries a substantial burden to society and to the individual affected.

Eligibility Criteria

This trial is for individuals with a complete ACL rupture who are scheduled for ACL reconstruction at the University of Michigan. Participants must be willing to follow the study's procedures and have an autograft procedure. Pregnant women, those planning pregnancy, patients with accompanying bony fractures or knee dislocations, or previous knee surgeries cannot join.

Inclusion Criteria

I had ACL reconstruction using my own tissue.

I am scheduled for ACL reconstruction surgery at the University of Michigan.

I have a completely torn ACL recently.

Exclusion Criteria

I have a broken bone along with an ACL injury.

I have had a knee dislocation.

I have had surgery on one or both of my knees.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NMES or NMES placebo for 8 weeks followed by eccentric exercise or placebo for another 8 weeks, alongside standard ACL rehabilitation

16 weeks

2 visits per week (in-person)

Follow-up

Participants are monitored for muscle strength and cartilage health at 6 and 18 months post-ACL reconstruction

18 months

Treatment Details

Interventions

• Eccentric Exercise (ECC)
• Eccentric Exercise (ECC) placebo
• Neuromuscular Electrical Stimulation (NMES)
• Neuromuscular Electrical Stimulation (NMES) placebo

Trial Overview The MiACLR trial is testing whether Neuromuscular Electrical Stimulation (NMES) and Eccentric Exercise (ECC), along with their placebos, can improve muscle function and cartilage health after ACL surgery to prevent post-traumatic knee osteoarthritis.

Participant Groups

Group I: NMES+ECC Experimental Treatment 2 Interventions

Neuromuscular electrical stimulation (NMES) and Eccentric Exercise (ECC). Patients randomized to the NMES+ECC group will first receive NMES for 2x/week for 8 weeks, beginning at the first post-operative visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive eccentric exercise 2x/week for an additional 8 weeks. For NMES, patients will have electrical stimulation delivered to their quadriceps. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For eccentric exercise, patients will train for 4 sets of 10 repetitions. This group will also receive standard of care ACL rehabilitation alongside the study interventions.

Group II: NMES placebo + ECC placebo Placebo Group 2 Interventions

Neuromuscular electrical stimulation (NMES) placebo + Eccentric Exercise (ECC)placebo arm. Patients randomized to the NMES placebo + ECC placebo group will first receive NMES placebo for 2x/week for 8 weeks, beginning at the first post-operative physical therapy visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive an eccentric exercise placebo 2x/week for 8 weeks. For the NMES placebo, patients will have NMES placebo delivered to their quadriceps 2x/week for 8 weeks beginning at the first post-operative visit. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For the eccentric exercise placebo, patients will begin to receive eccentric exercise two times per week for 8 weeks. Patients will train for 4 sets of 10 repetitions.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

University of Connecticut

Collaborator

Trials

194

Recruited

162,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+