Trial Outcomes & Findings for MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (NCT NCT03626857)
NCT ID: NCT03626857
Last Updated: 2026-01-02
Results Overview
Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)\*100
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
135 participants
Primary outcome timeframe
Post-NMES+ECC intervention (approximately 16 weeks post-ACL reconstruction)
Results posted on
2026-01-02
Participant Flow
Participants were recruited beginning in January of 2019 through July of 2023 from Michigan Medicine.
Participants were not randomized after enrollment for the following reasons: 1. Withdrew Consent 2. Screen fail 3. COVID drops (COVID pandemic prevented testing) 4. Lost to follow-up A baseline testing session occurred prior to randomization.
Participant milestones
| Measure |
Active High-Intensity NMES+ECC
Neuromuscular electrical stimulation (NMES) and Eccentric Exercise (ECC). Patients randomized to the NMES+ECC group will first receive high-intensity NMES for 2x/week for 8 weeks, beginning at the first post-operative visit. Beginning approximately 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.
|
Placebo Low-Intensity NMES + ECC
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 low dose eccentric exercise two times per week for 8 weeks. Patients will train for 4 sets of 10 repetitions.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
56
|
|
Overall Study
Post-NMES Intervention Testing
|
53
|
53
|
|
Overall Study
Post-ECC Intervention Testing
|
52
|
50
|
|
Overall Study
9 month post-ACLR testing
|
49
|
44
|
|
Overall Study
18 month post-ACLR testing
|
37
|
36
|
|
Overall Study
COMPLETED
|
37
|
36
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
Reasons for withdrawal
| Measure |
Active High-Intensity NMES+ECC
Neuromuscular electrical stimulation (NMES) and Eccentric Exercise (ECC). Patients randomized to the NMES+ECC group will first receive high-intensity NMES for 2x/week for 8 weeks, beginning at the first post-operative visit. Beginning approximately 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.
|
Placebo Low-Intensity NMES + ECC
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 low dose eccentric exercise two times per week for 8 weeks. Patients will train for 4 sets of 10 repetitions.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
7
|
|
Overall Study
Lost to Follow-up
|
8
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
3
|
Baseline Characteristics
MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
Baseline characteristics by cohort
| Measure |
NMES+ECC
n=57 Participants
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
n=56 Participants
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.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.9 years
STANDARD_DEVIATION 7.1 • n=228 Participants
|
23.0 years
STANDARD_DEVIATION 8.1 • n=115 Participants
|
22.9 years
STANDARD_DEVIATION 7.6 • n=343 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=228 Participants
|
26 Participants
n=115 Participants
|
52 Participants
n=343 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=228 Participants
|
30 Participants
n=115 Participants
|
61 Participants
n=343 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=228 Participants
|
8 Participants
n=115 Participants
|
16 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=228 Participants
|
10 Participants
n=115 Participants
|
17 Participants
n=343 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=228 Participants
|
36 Participants
n=115 Participants
|
76 Participants
n=343 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=228 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=228 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=343 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=228 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=343 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=228 Participants
|
51 Participants
n=115 Participants
|
105 Participants
n=343 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=228 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=343 Participants
|
PRIMARY outcome
Timeframe: Post-NMES+ECC intervention (approximately 16 weeks post-ACL reconstruction)Population: Active High-Intensity NMES + ECC: 2 subjects withdrawn by investigator, 0 subjects lost to follow up, 1 subject withdrew consent, 2 people missing strength data Placebo Low-Intensity NMES + ECC: 1 subjects withdrawn by investigator, 2 subjects lost to follow up, 2 subject withdrew consent, 1 person missing strength data
Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)\*100
Outcome measures
| Measure |
NMES+ECC
n=52 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
Immediately Post NMES+ECC Intervention Isokinetic Quadriceps Strength Index
|
60.9 Percentage
Standard Deviation 20.5
|
58.4 Percentage
Standard Deviation 19.2
|
PRIMARY outcome
Timeframe: 9 months (9 months post-ACL reconstruction)Population: Active High-Intensity NMES + ECC: 3 subjects withdrawn by investigator, 4 subjects lost to follow up, 1 subject withdrew consent Placebo Low-Intensity NMES + ECC: 4 subjects withdrawn by investigator, 6 subjects lost to follow up, 2 subject withdrew consent
Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)\*100
Outcome measures
| Measure |
NMES+ECC
n=49 Participants
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
n=44 Participants
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.
|
|---|---|---|
|
9 Months Isokinetic Quadriceps Strength Limb Symmetry Index
|
76.8 Percentage
Standard Deviation 18.0
|
74.5 Percentage
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: 9 months post-ACL reconstructionPopulation: Active High-Intensity NMES + ECC : 3 subjects withdrawn by investigator, 4 subjects lost to follow up, 1 subject withdrew consent, 16 subjects could not complete a single leg hop so data is missing Placebo Low-Intensity NMES + ECC: 4 subjects withdrawn by investigator, 6 subjects lost to follow up, 2 subject withdrew consent, 10 subjects could not complete a single leg hop so data is missing
Peak knee flexion angle of the ACL leg recorded during a single-legged hop (units: degrees)
Outcome measures
| Measure |
NMES+ECC
n=33 Participants
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
n=34 Participants
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.
|
|---|---|---|
|
Knee Flexion Angle at 9 Months
|
50.9 Degrees
Standard Deviation 14.4
|
44.4 Degrees
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: 9 months post-ACL reconstructionPopulation: Active High-Intensity NMES + ECC: 3 subjects withdrawn by investigator, 4 subjects lost to follow up, 1 subject withdrew consent, 16 subjects could not complete a single leg hop so data is missing Placebo Low-Intensity NMES + ECC: 4 subjects withdrawn by investigator, 6 subjects lost to follow up, 2 subject withdrew consent, 10 subjects could not complete a single leg hop so data is missing
Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg\*m)
Outcome measures
| Measure |
NMES+ECC
n=33 Participants
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
n=34 Participants
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.
|
|---|---|---|
|
Knee Flexion Moment at 9 Months
|
1.4 Nm/kg*m
Standard Deviation 0.3
|
1.3 Nm/kg*m
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 18 months post-ACL reconstructionPopulation: Active High-Intensity NMES + ECC: 10 subjects withdrawn by investigator, 8 subjects lost to follow up, 2 subjects withdrew consent, 7 subjects could not complete a single leg hop so data is missing Placebo Low-Intensity NMES + ECC: 7 subjects withdrawn by investigator, 10 subjects lost to follow up, 2 subjects withdrew consent, 6 subjects could not complete a single leg hop so data is missing
Peak knee flexion angle recorded during a single-legged hop (units: degrees)
Outcome measures
| Measure |
NMES+ECC
n=30 Participants
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
n=31 Participants
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.
|
|---|---|---|
|
Knee Flexion Angle at 18 Months
|
53.4 Degrees
Standard Deviation 14.7
|
48.8 Degrees
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 18 months post-ACL reconstructionPopulation: Active High-Intensity NMES + ECC: 10 subjects withdrawn by investigator, 8 subjects lost to follow up, 2 subject withdrew consent, 7 subjects could not complete a single leg hop so data is missing Placebo Low-Intensity NMES + ECC: 7 subjects withdrawn by investigator, 10 subjects lost to follow up, 2 subject withdrew consent, 6 subjects could not complete a single leg hop so data is missing
Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg\*m)
Outcome measures
| Measure |
NMES+ECC
n=30 Participants
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
n=31 Participants
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.
|
|---|---|---|
|
Knee Flexion Moment at 18 Months
|
1.5 Nm/kg*m
Standard Deviation 0.4
|
1.5 Nm/kg*m
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 18 months post-ACL reconstructionPopulation: Active High-Intensity NMES + ECC: 10 subjects withdrawn by investigator, 8 subjects lost to follow up, 2 subject withdrew consent, 1 person with MRI scan error so data is missing Placebo Low-Intensity NMES + ECC: 7 subjects withdrawn by investigator, 11 subjects lost to follow up, 2 subject withdrew consent
\[T1rho value at the weight bearing region of medial femur from MRI for ACL knee (msec)/T1rho value at the weight bearing region of medial femur for NonACL knee (msec)\] x 100
Outcome measures
| Measure |
NMES+ECC
n=36 Participants
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
n=36 Participants
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.
|
|---|---|---|
|
T1 Rho Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage
|
103.0 Percentage
Standard Deviation 15.9
|
106.1 Percentage
Standard Deviation 21.9
|
SECONDARY outcome
Timeframe: 18 months post-ACL reconstructionPopulation: NMES+ECC arm: 10 subjects withdrawn by investigator, 8 subjects lost to follow up, 2 subject withdrew consent, 1 person with MRI scan error so data is missing NMES placebo + ECC placebo arm: 7 subjects withdrawn by investigator, 11 subjects lost to follow up, 2 subject withdrew consent
\[T2 value from MRI at the central weight bearing region of femur for the ACL knee (msec)/T2 value from MRI at the central weight bearing region of femur for the NonACL knee (msec)\] x 100
Outcome measures
| Measure |
NMES+ECC
n=36 Participants
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
n=36 Participants
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.
|
|---|---|---|
|
T2 Relaxation Time Symmetry Score for Femoral Knee Joint Cartilage
|
101.3 Percentage
Standard Deviation 8.7
|
104.4 Percentage
Standard Deviation 9.8
|
Adverse Events
NMES+ECC
Serious events: 8 serious events
Other events: 2 other events
Deaths: 0 deaths
NMES Placebo + ECC Placebo
Serious events: 6 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NMES+ECC
n=57 participants at risk
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
n=56 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Appendectomy
|
1.8%
1/57 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
0.00%
0/56 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
1.8%
1/57 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
0.00%
0/56 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
|
Surgical and medical procedures
Septoplasty
|
0.00%
0/57 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
1.8%
1/56 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/57 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
1.8%
1/56 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for severe persistent asthma w/ exacerbation
|
0.00%
0/57 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
1.8%
1/56 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
|
Surgical and medical procedures
Meniscal Surgery
|
5.3%
3/57 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
0.00%
0/56 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
|
Surgical and medical procedures
Cyclops lesion excision
|
1.8%
1/57 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
1.8%
1/56 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
|
Musculoskeletal and connective tissue disorders
Anterolateral Ligament Reconstruction with partial ACL graft tear
|
1.8%
1/57 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
0.00%
0/56 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
|
Musculoskeletal and connective tissue disorders
Contralateral ACL tear
|
1.8%
1/57 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
1.8%
1/56 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
|
Musculoskeletal and connective tissue disorders
Knee arthroscopy
|
0.00%
0/57 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
1.8%
1/56 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
Other adverse events
| Measure |
NMES+ECC
n=57 participants at risk
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
n=56 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
ACL graft tear that was not reconstructed
|
3.5%
2/57 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
5.4%
3/56 • From the time of study enrollment until the last study visit occurring at 18 months after ACL reconstruction
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place