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NCT06341868 · ClinicalTrials.gov registry record · NA
Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets
A NA study of Anterior Cruciate Ligament Injuries, sponsored by Keller Army Community Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06341868: Recruiting NA study of Anterior Cruciate Ligament Injuries, sponsored by Keller Army Community Hospital.
NCT06341868 is a NA study of Anterior Cruciate Ligament Injuries that is actively recruiting participants, run by Keller Army Community Hospital. The registered enrollment target is 60 participants, below the 321-participant average among 24 other Anterior Cruciate Ligament Injuries trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06341868, a NA study of Anterior Cruciate Ligament Injuries, is actively recruiting participants, sponsored by Keller Army Community Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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..
Primary Outcome
Effects of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (femur sagittal angle, tibial sagittal angle, femur coronal angle, tibial coronal angle, femur and tibia coronal velocity)
Conditions Studied
Interventions
- DEVICE KneeStim
Study Locations (1)
New York
- Keller Army Community Hospital - West Point
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-09-19 |
| Est. Completion | 2026-09 |
| Phase | NA |
What NCT06341868 shows while recruiting
NCT06341868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 321-participant average among 24 other Anterior Cruciate Ligament Injuries trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Anterior Cruciate Ligament Injuries appearing as the primary indexed condition, and to 1 intervention - of which KneeStim is the first listed.
NCT06341868 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06341868 about?
NCT06341868 is a clinical study titled "Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets". 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 ...
What is the current status of trial NCT06341868?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-09-19. Estimated completion is 2026-09.
What conditions does trial NCT06341868 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Injuries.
What interventions are being tested in trial NCT06341868?
The interventions under investigation include: KneeStim (DEVICE).
Who is sponsoring clinical trial NCT06341868?
This trial is sponsored by Keller Army Community Hospital, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06341868 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06341868's enrollment target sits among peer trials
60 15th of 24 higher than 8 of 24 other Anterior Cruciate Ligament Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anterior Cruciate Ligament Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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