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NMES + ECC for ACL Injury (MiACLR Trial)

N/A

Waitlist Available

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute, complete ACL rupture

ACL reconstruction with autograft

Must not have

Patients who experienced a knee dislocation

Female participants who are pregnant or planning pregnancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-surgery (baseline), 18 months (18 months post-acl reconstruction)

Summary

This trial is testing ways to improve muscle function and cartilage health after surgery for a torn ACL. Knee osteoarthritis is a serious problem that causes a lot of pain and disability.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated in the provided information, potential side effects may include discomfort from NMES treatment such as skin irritation or muscle fatigue and soreness from ECC exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a completely torn ACL recently.

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I had ACL reconstruction using my own tissue.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a knee dislocation.

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I am currently pregnant or planning to become pregnant.

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

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I have a broken bone along with an ACL injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-surgery (baseline), 18 months (18 months post-acl reconstruction)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-surgery (baseline), 18 months (18 months post-acl reconstruction)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-surgery (baseline), 18 months (18 months post-acl reconstruction) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline to 18 months isokinetic quadriceps strength index

Change from baseline to 6 months isokinetic quadriceps strength index

Secondary study objectives

Knee Flexion Angle at 18 months

Knee Flexion Angle at 6 months

Knee Flexion Moment at 18 months

+3 more

Side effects data

From 2011 Phase 2 trial • 66 Patients • NCT00800254

Post-op complication

DVT

Severe Sciatica

100%

80%

60%

40%

20%

Study treatment Arm

Neuromuscular Electrical Stimulation (NMES)

Standard Rehabilitation Protocol

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NMES+ECCExperimental Treatment2 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 placeboPlacebo Group2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neuromuscular Electrical Stimulation (NMES)

2018

Completed Phase 2

~140

0 / 7Eligibility criteria met