MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
MiACLR
2 other identifiers
interventional
135
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2018
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedStudy Start
First participant enrolled
February 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2025
CompletedResults Posted
Study results publicly available
January 2, 2026
CompletedJanuary 2, 2026
December 1, 2025
5.9 years
August 8, 2018
November 18, 2025
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Immediately Post NMES+ECC Intervention Isokinetic Quadriceps Strength Index
Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)\*100
Post-NMES+ECC intervention (approximately 16 weeks post-ACL reconstruction)
9 Months Isokinetic Quadriceps Strength Limb Symmetry Index
Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)\*100
9 months (9 months post-ACL reconstruction)
Secondary Outcomes (6)
Knee Flexion Angle at 9 Months
9 months post-ACL reconstruction
Knee Flexion Moment at 9 Months
9 months post-ACL reconstruction
Knee Flexion Angle at 18 Months
18 months post-ACL reconstruction
Knee Flexion Moment at 18 Months
18 months post-ACL reconstruction
T1 Rho Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage
18 months post-ACL reconstruction
- +1 more secondary outcomes
Study Arms (2)
NMES+ECC
EXPERIMENTALNeuromuscular 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
PLACEBO COMPARATORNeuromuscular electrical stimulation (NMES) low intensity/placebo + Eccentric Exercise (ECC) low intensity/placebo arm. Patients randomized to the NMES low intesntiy/placebo + ECC low intensity/placebo group will first receive NMES placebo/low-intensity treatment 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 low-intensity/placebo 2x/week for 8 weeks. For the NMES low intensity/placebo, patients will have it 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 low-intensity/placebo, patients will begin to receive eccentric exercise two times per week for 8 weeks. Patients will train for 4 sets of 10 repetitions.
Interventions
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.
4 sets of 10 repetitions of an eccentric leg press exercise performed at 70-90% of the 1 repetition maximum
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.
4 sets of 10 repetitions of an eccentric leg press exercise performed at 10-20% of the 1 repetition maximum
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous surgery to either knee
- Bony fracture accompanying ACL injury
- Patients who experienced a knee dislocation
- Female participants who are pregnant or planning pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
- University of Connecticutcollaborator
- University of Delawarecollaborator
- University of North Carolina, Chapel Hillcollaborator
Study Sites (2)
MedSport
Ann Arbor, Michigan, 48109, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Rodriguez K, Garcia SA, Spino C, Lepley LK, Pang Y, Wojtys E, Bedi A, Angelini M, Ruffino B, Bolley T, Block C, Kellum J, Swartout A, Palmieri-Smith RM. Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (MiACLR): A Protocol for a Randomized Clinical Trial. Phys Ther. 2020 Dec 7;100(12):2154-2164. doi: 10.1093/ptj/pzaa169.
PMID: 32939539DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Riann Palmieri-Smith, PhD, ATC
- Organization
- University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 8, 2018
First Posted
August 13, 2018
Study Start
February 22, 2019
Primary Completion
January 9, 2025
Study Completion
January 9, 2025
Last Updated
January 2, 2026
Results First Posted
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share