Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT06341868
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2024-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets
Sponsor:
Keller Army Community Hospital
Organization:
Study Overview
Official Title:
Dynamic Gait-Synchronous Neuromuscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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..
* 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..
Detailed Description:
Anterior cruciate ligament (ACL) tears have a recovery time of nearly 6-12 months with operative treatment. While most service members return to full duty after ACL reconstruction, it is delayed by quadriceps activation, muscle weakness, and abnormal gait patterns. Neuromuscular electric stimulation devices are already being used in physical therapy to complement gains in muscle strength and size. The innovation of KneeStim, is that it can be used to stimulate knee muscles while the individual is engaging in their daily activities. This study looks at the effects of 12 weeks of post-operative use of the KneeStim on biomechanical function (gait) in United States Military Academy Cadets aged 17-27 years of age. The investigators hypothesize that using the KneeStim will accelerate normalization of the biomechanical function parameters of gait and thus return to full duty.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 23KACH008 | OTHER | Keller Army Community Hospital | View |