Study Summary
This trial is testing ways to improve muscle function and cartilage health after surgery for a torn ACL. Knee osteoarthritis is a serious problem that causes a lot of pain and disability.
Eligible Conditions
- Anterior Cruciate Ligament (ACL) Injury
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 6 Secondary · Reporting Duration: Pre-surgery (baseline), 18 months (18 months post-ACL reconstruction)
18 months post-ACL reconstruction
Knee Flexion Angle at 18 months
Knee Flexion Moment at 18 months
T1 rho relaxation time symmetry scores for knee joint cartilage
T2 relaxation time symmetry scores for knee joint cartilage
6 months post-ACL reconstruction
Knee Flexion Angle at 6 months
Knee Flexion Moment at 6 months
Month 18
Change from baseline to 18 months isokinetic quadriceps strength index
Month 6
Change from baseline to 6 months isokinetic quadriceps strength index
Trial Safety
Safety Progress
Side Effects for
Neuromuscular Electrical Stimulation (NMES)
3%Post-op complication
3%Severe Sciatica
3%DVT
Trial Design
2 Treatment Groups
NMES+ECC
1 of 2
NMES placebo + ECC placebo
1 of 2
Experimental Treatment
Non-Treatment Group
102 Total Participants · 2 Treatment Groups
Primary Treatment: Neuromuscular Electrical Stimulation (NMES) · Has Placebo Group · N/A
NMES+ECCExperimental Group · 2 Interventions: Neuromuscular Electrical Stimulation (NMES), Eccentric Exercise (ECC) · Intervention Types: Device, Other
NMES placebo + ECC placeboPlaceboComparator Group · 2 Interventions: Neuromuscular Electrical Stimulation (NMES) placebo, Eccentric Exercise (ECC) placebo · Intervention Types: Device, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neuromuscular Electrical Stimulation (NMES)
2018
Completed Phase 2
~140
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-surgery (baseline), 18 months (18 months post-acl reconstruction)
Who is running the clinical trial?
University of North Carolina, Chapel HillOTHER
1,367 Previous Clinical Trials
3,919,975 Total Patients Enrolled
University of DelawareOTHER
135 Previous Clinical Trials
36,669 Total Patients Enrolled
University of MichiganLead Sponsor
1,626 Previous Clinical Trials
6,416,919 Total Patients Enrolled
University of ConnecticutOTHER
161 Previous Clinical Trials
156,464 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,821 Previous Clinical Trials
2,238,034 Total Patients Enrolled
Eligibility Criteria
Age 14 - 45 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are willing to participate in testing and follow-up as outlined.
References
- Rodriguez, Kazandra, Steven A Garcia, Cathie Spino, Lindsey K Lepley, Yuxi Pang, Edward Wojtys, Asheesh Bedi, et al.. 2020. “Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (miaclr): A Protocol for a Randomized Clinical Trial”. Physical Therapy. Oxford University Press (OUP). doi:10.1093/ptj/pzaa169.
- Riann Palmieri-Smith 2019. "MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03626857.
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Conditions
Cancer Related
Treatments