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MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
NA trial testing Neuromuscular Electrical Stimulation (NMES) in Anterior Cruciate Ligament Injury in 135 participants. Completed in 9 January 2025.
| Lead sponsor | University of Michigan |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 135 |
| Start date | 22 February 2019 |
| Primary completion | 9 January 2025 |
| Estimated completion | 9 January 2025 |
| Sites | 2 locations across United States |
University of Michigan
Adults 14 to 45, any sex, with Anterior Cruciate Ligament Injury. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)\*100
| Group | Value | 95% CI |
|---|---|---|
| NMES+ECC | 60.9 | ± 20.5 |
| NMES placebo + ECC placebo | 58.4 | ± 19.2 |
Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)\*100
| Group | Value | 95% CI |
|---|---|---|
| NMES+ECC | 76.8 | ± 18.0 |
| NMES placebo + ECC placebo | 74.5 | ± 19.6 |
Peak knee flexion angle of the ACL leg recorded during a single-legged hop (units: degrees)
| Group | Value | 95% CI |
|---|---|---|
| NMES+ECC | 50.9 | ± 14.4 |
| NMES placebo + ECC placebo | 44.4 | ± 12.9 |
Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg\*m)
| Group | Value | 95% CI |
|---|---|---|
| NMES+ECC | 1.4 | ± 0.3 |
| NMES placebo + ECC placebo | 1.3 | ± 0.3 |
Peak knee flexion angle recorded during a single-legged hop (units: degrees)
| Group | Value | 95% CI |
|---|---|---|
| NMES+ECC | 53.4 | ± 14.7 |
| NMES placebo + ECC placebo | 48.8 | ± 11.4 |
Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg\*m)
| Group | Value | 95% CI |
|---|---|---|
| NMES+ECC | 1.5 | ± 0.4 |
| NMES placebo + ECC placebo | 1.5 | ± 0.3 |
\[T1rho value at the weight bearing region of medial femur from MRI for ACL knee (msec)/T1rho value at the weight bearing region of medial femur for NonACL knee (msec)\] x 100
| Group | Value | 95% CI |
|---|---|---|
| NMES+ECC | 103.0 | ± 15.9 |
| NMES placebo + ECC placebo | 106.1 | ± 21.9 |
\[T2 value from MRI at the central weight bearing region of femur for the ACL knee (msec)/T2 value from MRI at the central weight bearing region of femur for the NonACL knee (msec)\] x 100
| Group | Value | 95% CI |
|---|---|---|
| NMES+ECC | 101.3 | ± 8.7 |
| NMES placebo + ECC placebo | 104.4 | ± 9.8 |
Time frame: From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | NMES+ECC | NMES Placebo + ECC Placebo |
|---|---|---|---|
| Meniscal Surgery | Surgical and medical procedures | — | — |
| Appendectomy | Surgical and medical procedures | — | — |
| Accidental Overdose | Injury, poisoning and procedural complications | — | — |
| Septoplasty | Surgical and medical procedures | — | — |
| Loss of Consciousness | Nervous system disorders | — | — |
| Hospitalization for severe persistent asthma w/ exacerbation | Respiratory, thoracic and mediastinal disorders | — | — |
| Cyclops lesion excision | Surgical and medical procedures | — | — |
| Anterolateral Ligament Reconstruction with partial ACL graft tear | Musculoskeletal and connective tissue disorders | — | — |
| Contralateral ACL tear | Musculoskeletal and connective tissue disorders | — | — |
| Knee arthroscopy | Musculoskeletal and connective tissue disorders | — | — |
| Reaction | System | NMES+ECC | NMES Placebo + ECC Placebo |
|---|---|---|---|
| ACL graft tear that was not reconstructed | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Meniscal Surgery, Appendectomy, Accidental Overdose, Septoplasty, Loss of Consciousness, Hospitalization for severe persistent asthma w/ exacerbation, Cyclops lesion excision, Anterolateral Ligament Reconstruction with partial ACL graft tear.
Data from ClinicalTrials.gov NCT03626857 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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