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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

MiACLR Trial 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.Check my eligibility

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.See study design

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.

MiACLR Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have a completely torn ACL recently.

Select...

I had ACL reconstruction using my own tissue.

Select...

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

MiACLR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline to 18 months isokinetic quadriceps strength index

Change from baseline to 6 months isokinetic quadriceps strength index

Secondary outcome measures

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

MiACLR 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER

1,506 Previous Clinical Trials

4,190,432 Total Patients Enrolled

1 Trials studying Anterior Cruciate Ligament Injury

48 Patients Enrolled for Anterior Cruciate Ligament Injury

University of DelawareOTHER

154 Previous Clinical Trials

25,082 Total Patients Enrolled

2 Trials studying Anterior Cruciate Ligament Injury

167 Patients Enrolled for Anterior Cruciate Ligament Injury

University of MichiganLead Sponsor

1,796 Previous Clinical Trials

6,377,824 Total Patients Enrolled

4 Trials studying Anterior Cruciate Ligament Injury

153 Patients Enrolled for Anterior Cruciate Ligament Injury

Media Library

Eccentric Exercise (ECC) Clinical Trial Eligibility Overview. Trial Name: NCT03626857 — N/A

Anterior Cruciate Ligament Injury Research Study Groups: NMES placebo + ECC placebo, NMES+ECC

Anterior Cruciate Ligament Injury Clinical Trial 2023: Eccentric Exercise (ECC) Highlights & Side Effects. Trial Name: NCT03626857 — N/A

Eccentric Exercise (ECC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03626857 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the requirements to be a part of this research project?

"The eligibility criteria for this clinical trial includes patients that have anterior cruciate ligament damage and are between the ages of 14 to 45. Up to 102 individuals will be accepted into the study."

Answered by AI

Are there still positions available in this trial for potential participants?

"Yes, this study is still recruiting patients according to the latest update on clinicaltrials.gov from October 24th, 2022. The trial was initially posted almost 4 years ago on February 22nd, 2019."

Answered by AI

Does this research include testing on elderly adults?

"This clinical trial is open to adolescents aged 14 or older, as well as adults younger than 45."

Answered by AI

How many individuals are being recruited for this clinical trial?

"That is accurate. The clinical trial in question, which was originally posted on February 22nd 2019 according to clinicaltrials.gov, is still looking for participants. So far, 102 patients have been enrolled at 2 sites."

Answered by AI

Recent research and studies

Physical TherapyJournal

Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (miaclr): A Protocol for a Randomized Clinical Trial

Rodriguez, Kazandra, Steven A Garcia, Cathie Spino, Lindsey K Lepley, Yuxi Pang, Edward Wojtys, Asheesh Bedi, et al.. 2020. “Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (miaclr): A Protocol for a Randomized Clinical Trial”. Physical Therapy. Oxford University Press (OUP). doi:10.1093/ptj/pzaa169.

clinicaltrials.govStudy

MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation

Riann Palmieri-Smith 2019. "MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03626857.