MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation

Anterior Cruciate Ligament Injury Clinical Trial

— MiACLR  

Official title:

MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03626857
• Other study ID #: HUM00144992
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 45 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury

Intervention

Device:
• Neuromuscular Electrical Stimulation (NMES)
The electrical stimulator will deliver a 2500 Hz alternating current, modulated at 75 bursts/s, with a ramp-up time of 2-seconds, followed by a 50-second rest period. Stimulus intensity set to generate a maximum voluntary isometric contraction (MVIC) of at least 40& of the contralateral MVIC.

Other:
• Eccentric Exercise (ECC)
4 sets of 10 repetitions of an eccentric leg press exercise performed at 70-90% of the 1 repetition maximum

Device:
• Neuromuscular Electrical Stimulation (NMES) placebo
The electrical stimulator will deliver a 2500 Hz alternating current, modulated at 75 bursts/s, with a ramp-up time of 2-seconds, followed by a 50-second rest period. Stimulus intensity set to generate a maximum voluntary isometric contraction (MVIC) of 10-20% of the contralateral MVIC.

Other:
• Eccentric Exercise (ECC) placebo
4 sets of 10 repetitions of an eccentric leg press exercise performed at 10-20% of the 1 repetition maximum

Locations

Country	Name	City	State
United States	MedSport	Ann Arbor	Michigan
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (5)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Connecticut, University of Delaware, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to 6 months isokinetic quadriceps strength index	concentric isokinetic muscle strength at 60 degrees per second	Pre-surgery (baseline), 6 months (6 months post-ACL reconstruction)
Primary	Change from baseline to 18 months isokinetic quadriceps strength index	concentric isokinetic muscle strength at 60 degrees per second	Pre-surgery (baseline), 18 months (18 months post-ACL reconstruction)
Secondary	T1 rho relaxation time symmetry scores for knee joint cartilage	[T1rho value from MRI for right knee (msec)/T1rho value for left knee (msec)] x 100	18 months post-ACL reconstruction
Secondary	T2 relaxation time symmetry scores for knee joint cartilage	[T2 value from MRI for right knee (msec)/T2 value for left knee (msec)] x 100	18 months post-ACL reconstruction
Secondary	Knee Flexion Angle at 6 months	Peak knee flexion angle recorded during a single-legged hop (units: degrees)	6 months post-ACL reconstruction
Secondary	Knee Flexion Angle at 18 months	Peak knee flexion angle recorded during a single-legged hop (units: degrees)	18 months post-ACL reconstruction
Secondary	Knee Flexion Moment at 6 months	Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)	6 months post-ACL reconstruction
Secondary	Knee Flexion Moment at 18 months	Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)	18 months post-ACL reconstruction