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Standard of Care + KneeStim flexible intensity for Anterior Cruciate Ligament Injury

N/A

Recruiting

Led By Shawn M Gee, MD

Research Sponsored by Keller Army Community Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-operative, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months post-operative

Awards & highlights

Study Summary

This trial aims to study the effects of using a new knee sleeve device with electrical stimulation called KneeStim for 12 weeks after knee surgery on how well cadets from the United States Military Academy can

Who is the study for?

This trial is for US Military Academy cadets aged 17-27 who've had ACL reconstruction. They'll test a knee sleeve device (KneeStim) during recovery to see if it improves walking, muscle mass, and speeds up return to duty. Cadets must be able to undergo MRI and strength tests.Check my eligibility

What is being tested?

The study compares the effects of KneeStim at low vs. flexible intensities on post-surgery gait, muscle growth, patient-reported outcomes, and time to full duty. It includes body analysis, MRI, strength testing, gait analysis with a control group for comparison.See study design

What are the potential side effects?

Potential side effects are not specified but may include discomfort or skin irritation from wearing the KneeStim device daily and possible soreness from electrical stimulation during rehabilitation exercises.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operative, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-operative, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in gait post-operatively assessed by the KneeStimTM Device

Secondary outcome measures

ACL graft healing assessed by MRI

Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA)

Change in isometric muscle strength assessed by CSMi HUMAC NORM

+14 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Standard of Care + KneeStim flexible intensityExperimental Treatment1 Intervention

Flexible to high intensity range

Group II: Standard of Care + KneeStim controlled low intensityPlacebo Group1 Intervention

Low intensity range

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical Technology Enterprise ConsortiumUNKNOWN

1 Previous Clinical Trials

100 Total Patients Enrolled

Keller Army Community HospitalLead Sponsor

15 Previous Clinical Trials

2,029 Total Patients Enrolled

1 Trials studying Anterior Cruciate Ligament Injury

40 Patients Enrolled for Anterior Cruciate Ligament Injury

Shawn M Gee, MDPrincipal InvestigatorKeller Army Community Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to participate in this research study?

"That's accurate. The details on clinicaltrials.gov highlight that this investigation is actively seeking participants. Initial posting of the study was on April 1, 2024, with the most recent update occurring on March 25, 2024. The trial aims to recruit a total of 60 individuals at a single research site."

Answered by AI

Who is eligible to participate in this clinical trial?

"To be eligible for this study, individuals must have sustained an anterior cruciate ligament injury and fall within the age range of 17 to 27 years. A total of 60 participants will be enrolled in this trial."

Answered by AI

Are individuals who are above the age of 35 eligible to participate in this research study?

"Individuals aged over 17 and under 27 are eligible for participation in this trial."

Answered by AI

What is the upper limit for patient enrollment in this particular clinical investigation?

"Indeed, the details on clinicaltrials.gov affirm that recruitment for this medical trial is ongoing. The study was initially published on April 1st, 2024 and last revised on March 25th, 2024. A total of 60 individuals are sought from a single site."

Answered by AI

Recent research and studies

Journal of Orthopaedic & Sports Physical TherapyJournal

Knee Extensor Rate of Torque Development Before and After Arthroscopic Partial Meniscectomy, with Analysis of Neuromuscular Mechanisms

Cobian, Daniel G., Cameron M. Koch, Annunziato Amendola, and Glenn N. Williams. 2017. “Knee Extensor Rate of Torque Development Before and After Arthroscopic Partial Meniscectomy, with Analysis of Neuromuscular Mechanisms”. Journal of Orthopaedic & Sports Physical Therapy. Journal of Orthopaedic & Sports Physical Therapy (JOSPT). doi:10.2519/jospt.2017.7310.

American Journal of Preventive MedicineJournal

Musculoskeletal Injuries

Hauret, Keith G., Bruce H. Jones, Steven H. Bullock, Michelle Canham-Chervak, and Sara Canada. 2010. “Musculoskeletal Injuries”. American Journal of Preventive Medicine. Elsevier BV. doi:10.1016/j.amepre.2009.10.021.

The American Journal of Sports MedicineJournal

Impaired Quadriceps Rate of Torque Development and Knee Mechanics After Anterior Cruciate Ligament Reconstruction with Patellar Tendon Autograft

Kline, Paul W., Kristin D. Morgan, Darren L. Johnson, Mary Lloyd Ireland, and Brian Noehren. 2015. “Impaired Quadriceps Rate of Torque Development and Knee Mechanics After Anterior Cruciate Ligament Reconstruction with Patellar Tendon Autograft”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546515595834.

JAAOS: Global Research and ReviewsJournal