MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation

Not Applicable

Active, not recruiting

• Conditions: Anterior Cruciate Ligament Injury
• Interventions: Device: Neuromuscular Electrical Stimulation (NMES); Device: Neuromuscular Electrical Stimulation (NMES) placebo; Other: Eccentric Exercise (ECC) placebo; Other: Eccentric Exercise (ECC)

• Registration Number: NCT03626857
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Restoring quadriceps muscle strength following anterior cruciate ligament reconstruction (ACLR) may help prevent the post-traumatic knee osteoarthritis that affects over 50% of knees 10-20 years after surgical reconstruction. However, a fundamental gap exists in current understanding of how to maximize muscle strength following ACLR, as current rehabilitation fails to restore symmetrical quadriceps strength. The investigators pilot work shows that when patients return to activity, quadriceps strength is \~70% of the uninjured side, which is far below the recommended 90%. Further, these data suggest that embedding high-intensity neuromuscular electrical stimulation (NMES) and eccentric exercise into standard of care ACL rehabilitation leads to higher quadriceps strength when compared with standard of care alone. However, the true efficacy of these interventions is unknown, as controlled trials with adequate sample sizes are currently lacking. The absence of this information serves as the driving force and focus of the proposed trial. Therefore, the investigators propose a double-blind randomized controlled trial where ACLR patients will be randomized to 1 of 2 arms. Study arms will include: 1) 8 weeks of NMES+8 weeks of eccentric exercise; 2) 8 weeks of NMES placebo+8 weeks of eccentric placebo. All study arms will receive standard of care ACL rehabilitation in addition to the study interventions. The investigators hypothesize that subjects receiving NMES+eccentric exercise (Arm 1) will realize greater improvements in strength and biomechanical function at 6 months following ACLR than patients in the placebo study arm. Further, the investigators anticipate that patients in the NMES+eccentric exercise arm (Arm 1) will best eliminate negative changes in cartilage health at 18 months following ACLR. This study is innovative, because it employs interventions that directly target the primary mechanisms that result in strength loss following ACLR and will also evaluate whether improving muscle strength can minimize early changes in cartilage health, which may be indicative of future osteoarthritis. The proposed research is significant because it will identify evidence-based treatment approaches that can successfully counteract the muscle weakness which plagues ACLR patients for years after injury and contributes to the onset of post-traumatic osteoarthritis.

Study Timeline

• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-13
• Study Start: 2019-02-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Acute, complete ACL rupture
• ACL reconstruction with autograft
• Scheduled to undergo ACLR at U of Michigan
• Willingness to participate in testing and follow-up as outlined

Read More

Exclusion Criteria

• Previous surgery to either knee
• Bony fracture accompanying ACL injury
• Patients who experienced a knee dislocation
• Female participants who are pregnant or planning pregnancy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMES+ECC	Neuromuscular Electrical Stimulation (NMES)	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.
NMES placebo + ECC placebo	Eccentric Exercise (ECC) placebo	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.
NMES+ECC	Eccentric Exercise (ECC)	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.
NMES placebo + ECC placebo	Neuromuscular Electrical Stimulation (NMES) placebo	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline to 18 months isokinetic quadriceps strength index	Pre-surgery (baseline), 18 months (18 months post-ACL reconstruction)	concentric isokinetic muscle strength at 60 degrees per second
Change from baseline to 6 months isokinetic quadriceps strength index	Pre-surgery (baseline), 6 months (6 months post-ACL reconstruction)	concentric isokinetic muscle strength at 60 degrees per second

Secondary Outcome Measures

Name	Time	Method
T2 relaxation time symmetry scores for knee joint cartilage	18 months post-ACL reconstruction	\[T2 value from MRI for right knee (msec)/T2 value for left knee (msec)\] x 100
Knee Flexion Moment at 6 months	6 months post-ACL reconstruction	Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)
T1 rho relaxation time symmetry scores for knee joint cartilage	18 months post-ACL reconstruction	\[T1rho value from MRI for right knee (msec)/T1rho value for left knee (msec)\] x 100
Knee Flexion Angle at 18 months	18 months post-ACL reconstruction	Peak knee flexion angle recorded during a single-legged hop (units: degrees)
Knee Flexion Moment at 18 months	18 months post-ACL reconstruction	Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)
Knee Flexion Angle at 6 months	6 months post-ACL reconstruction	Peak knee flexion angle recorded during a single-legged hop (units: degrees)

Trial Locations

Locations (2)

MedSport; 🇺🇸 Ann Arbor, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States