Anterior Cruciate Ligament InjuryMiACLRNCT03626857
MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
A study testing Neuromuscular Electrical Stimulation (NMES) and Eccentric Exercise (ECC) in people with Anterior Cruciate Ligament Injury, run by University of Michigan at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Neuromuscular Electrical Stimulation (NMES) and Eccentric Exercise (ECC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2019to 9 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Previous surgery to either knee
- Bony fracture accompanying ACL injury
- Patients who experienced a knee dislocation
- Female participants who are pregnant or planning pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MedSport
Ann Arbor, Michigan, 48109
University of Michigan
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Neuromuscular Electrical Stimulation (NMES), Eccentric Exercise (ECC), Neuromuscular Electrical Stimulation (NMES) placebo, Eccentric Exercise (ECC) placebo
- Keywords
- Knee, ACL, Reconstruction, Rehabilitation, Eccentric Exercise, Electrical Stimulation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical Stimulation (NMES)Device
Also called Electrical Stimulation, Estim
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.
Eccentric Exercise (ECC)Other
4 sets of 10 repetitions of an eccentric leg press exercise performed at 70-90% of the 1 repetition maximum
Neuromuscular Electrical Stimulation (NMES) placeboDevice
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.
Eccentric Exercise (ECC) placeboOther
4 sets of 10 repetitions of an eccentric leg press exercise performed at 10-20% of the 1 repetition maximum
| Study group | Role | What they receive |
|---|---|---|
| NMES+ECC | Experimental | 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. Receives: Device: Neuromuscular Electrical Stimulation (NMES); Other: Eccentric Exercise (ECC) |
| NMES placebo + ECC placebo | Placebo comparator | Neuromuscular 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. Receives: Device: Neuromuscular Electrical Stimulation (NMES) placebo; Other: Eccentric Exercise (ECC) placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 9 months (9 months post-ACL reconstruction)
Secondary outcomes (6)
Knee Flexion Angle at 9 Months
Peak knee flexion angle of the ACL leg recorded during a single-legged hop (units: degrees)
Measured: 9 months post-ACL reconstruction
Knee Flexion Moment at 9 Months
Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg*m)
Measured: 9 months post-ACL reconstruction
Knee Flexion Angle at 18 Months
Peak knee flexion angle recorded during a single-legged hop (units: degrees)
Measured: 18 months post-ACL reconstruction
Knee Flexion Moment at 18 Months
Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg*m)
Measured: 18 months post-ACL reconstruction
T1 Rho Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage
[T1rho value at the weight bearing region of medial femur from MRI for ACL knee (msec)/T1rho value at the weight bearing region of medial femur for NonACL knee (msec)] x 100
Measured: 18 months post-ACL reconstruction
T2 Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage
[T2 value from MRI at the central weight bearing region of femur for the ACL knee (msec)/T2 value from MRI at the central weight bearing region of femur for the NonACL knee (msec)] x 100
Measured: 18 months post-ACL reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start22 Feb 2019
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Connecticut, University of Delaware, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Riann Palmieri-Smith, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626857
- Sponsor's protocol ID
- HUM00144992
- Other IDs
- 1R01HD093626-01A1
- Acronym
- MiACLR
- Status last verified
- Dec 2025
- First submitted
- 8 Aug 2018
- Last updated
- 2 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32939539
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
- ClinicalTrials.gov ID
- NCT03626857
- Acronym / sponsor ID
- MiACLR / HUM00144992
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- Knee, ACL, Reconstruction, Rehabilitation, Eccentric Exercise, Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Connecticut, University of Delaware, University of North Carolina, Chapel Hill
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Posted 2 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES+ECC | Experimental | Device: Neuromuscular Electrical Stimulation (NMES), Other: 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 | Placebo comparator | Device: Neuromuscular Electrical Stimulation (NMES) placebo, Other: Eccentric Exercise (ECC) placeboNeuromuscular 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. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Previous surgery to either knee
- Bony fracture accompanying ACL injury
- Patients who experienced a knee dislocation
- Female participants who are pregnant or planning pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Electrical Stimulation (NMES)Also: Electrical Stimulation, EstimThe 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. | Device | NMES+ECC |
| Eccentric Exercise (ECC)4 sets of 10 repetitions of an eccentric leg press exercise performed at 70-90% of the 1 repetition maximum | Other | NMES+ECC |
| Neuromuscular Electrical Stimulation (NMES) placeboThe 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. | Device | NMES placebo + ECC placebo |
| Eccentric Exercise (ECC) placebo4 sets of 10 repetitions of an eccentric leg press exercise performed at 10-20% of the 1 repetition maximum | Other | NMES placebo + ECC placebo |
Primary outcome
Immediately Post NMES+ECC Intervention Isokinetic Quadriceps Strength Index
Time frame: Post-NMES+ECC intervention (approximately 16 weeks post-ACL reconstruction)
Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)*100
9 Months Isokinetic Quadriceps Strength Limb Symmetry Index
Time frame: 9 months (9 months post-ACL reconstruction)
Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)*100
6 secondary outcomes
Knee Flexion Angle at 9 Months
Time frame: 9 months post-ACL reconstruction
Knee Flexion Moment at 9 Months
Time frame: 9 months post-ACL reconstruction
Knee Flexion Angle at 18 Months
Time frame: 18 months post-ACL reconstruction
Knee Flexion Moment at 18 Months
Time frame: 18 months post-ACL reconstruction
T1 Rho Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage
Time frame: 18 months post-ACL reconstruction
T2 Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage
Time frame: 18 months post-ACL reconstruction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32939539Rodriguez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation (NMES) and Eccentric Exercise (ECC) in people with Anterior Cruciate Ligament Injury, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediately Post NMES+ECC Intervention Isokinetic Quadriceps Strength Index (time frame: Post-NMES+ECC intervention (approximately 16 weeks post-ACL reconstruction)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03626857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.