RECRUITING

Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to examine the effects of 12 weeks of post-operative use of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (gait). Participants will be United States Military Academy cadets aged 17-27 years. The main questions it aims to answer are: * Examine the effects of KneeStim wear on cadets' post-operative gait * Examine changes in site-specific skeletal muscle mass * Examine the changes in patient-reported outcomes * Assess time to return to full duty * Compare Bioelectrical Impedance Analysis (BIA) measurements to Magnetic Resonance Imaging (MRI) measurements (total thigh volume) * Determine the concurrent criterion validity of the KneeStim device compared to gold- standard metrics (3D Motion Capture) Participants will undergo body composition analysis, MRI, strength testing, standard of care rehabilitation, gait analysis, and complete surveys. Participants will wear the KneeStim during their standard of care rehabilitation visits for the first 5 weeks post-operative, and throughout daily tasks from 6-12 weeks. Researchers will compare a control group (standard of care + KneeStim controlled low intensity) to an experimental group (standard of care + KneeStim flexible intensity) to assess the aims previously mentioned..

Official Title

Dynamic Gait-Synchronous Neuromuscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction

Quick Facts

Study Start:2024-04-01
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06341868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:17 Years to 27 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. United States Military Academy cadet between ages of 17-27 years
  2. 2. undergoing anterior cruciate ligament reconstruction
  1. 1. Previous ligamentous surgery in ipsilateral knee
  2. 2. Concomitant or prior high tibial osteotomy (HTO)
  3. 3. Concomitant or prior cartilage restoration procedure
  4. 4. Concomitant ligamentous reconstruction (lateral collateral ligament; posterior cruciate ligament; medial collateral ligament)
  5. 5. Contraindications to using the KneeStim device
  6. 6. Meniscus tear precluding weight bearing for 6 weeks.

Contacts and Locations

Study Contact

Natalia B Prando, BA
CONTACT
845-938-5325
natalia.b.prando.ctr@health.mil
Paige A McHenry, MS
CONTACT
845-938-2630
paige.a.mchenry.ctr@health.mil

Principal Investigator

Shawn M Gee, MD
PRINCIPAL_INVESTIGATOR
Keller Army Community Hospital

Study Locations (Sites)

Keller Army Community Hospital
West Point, New York, 10996
United States

Collaborators and Investigators

Sponsor: Keller Army Community Hospital

  • Shawn M Gee, MD, PRINCIPAL_INVESTIGATOR, Keller Army Community Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2026-09-01

Terms related to this study

Keywords Provided by Researchers

  • knee
  • Anterior Cruciate Ligament
  • Gait
  • Neuromuscular electric stimulation

Additional Relevant MeSH Terms

  • Anterior Cruciate Ligament Injuries