Anterior Cruciate Ligament InjuriesNCT06341868
Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets
A study testing KneeStim in people with Anterior Cruciate Ligament Injuries, run by Keller Army Community Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 27 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- KneeStim
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- United States Military Academy cadet between ages of 17-27 years
- Undergoing a Primary ACL Reconstruction, or Revision ACL Reconstruction
Who cannot join
- Concomitant or prior high tibial osteotomy (HTO)
- Concomitant or prior cartilage restoration procedure
- Concomitant ligamentous reconstruction (lateral collateral ligament; posterior cruciate ligament; medial collateral ligament)
- Contraindications to using the KneeStim device
- Use of pacemaker, defibrillators, or other implanted electronic devices, as this may cause electric shock, burns, electrical interference, or death Unstable angina or decompensated heart failure Epilepsy or history of seizure disorder Pregnancy or planning to become pregnant (Self reported) Critical ischemia of lower limbs Moderate to severe dementia Altered sensation at the knee such that the user cannot feel a pinprick Undiagnosed pain syndromes
- Any meniscus tear precluding weight bearing for 6 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Keller Army Community Hospital
West Point, New York, 10996
Natalia B Prando, MA, 315-774-8368, natalia.b.prando.ctr@health.mil
Madison Mach, PhD, 315-774-8368, madison.s.mach.ctr@health.mil
About this study
Official title: Dynamic Gait-Synchronous Neuromuscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction
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)
Read more
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..
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- KneeStim
- Keywords
- knee, Anterior Cruciate Ligament, Gait, Neuromuscular electric stimulation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KneeStimDevice
Participant will be randomized to either be in control or experimental group
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care + KneeStim controlled low intensity | Sham comparator | Low intensity range Receives: Device: KneeStim |
| Standard of Care + KneeStim flexible intensity | Experimental | Flexible to high intensity range Receives: Device: KneeStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait post-operatively assessed by the KneeStimTM Device
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)
Measured: 6 weeks;3, 6, 9, 12 months post-operative
Secondary outcomes (19)
change in gait post-operatively assessed by 3D Motion capture
Kinetic and kinematic biomechanical data will be monitored throughout the return to run phases of rehabilitation in knee and hip joints (walking and running); changes in gait speed (walking and running); changes in join angle range of motion (walking and running); changes in stride length (walking and running)
Measured: 3, 6, 9, 12 months post-operative
change in gait post-operatively assessed by force plate instrumented treadmill
Ground reaction forces will be recorded simultaneously with the motion capture system via force plates on an instrumented treadmill to determine force output between limbs during walking and running trials.
Measured: 3, 6, 9, 12 months post-operative
change in muscle volume assessed by MRI
Summation of the cross-sectional area and volumetric measurements
Measured: pre-operative, 3, 6, 9, 12 months post-operative
ACL graft healing assessed by MRI
Signal intensity will be used to monitor tissue quality throughout healing process
Measured: pre-operative, 3, 6, 9, 12 months post-operative
Change in isometric muscle strength assessed by CSMi HUMAC NORM
Rate of torque development (in ms) over time.
Measured: 3, 6, 9, 12 months post-operative
Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA)
Skeletal muscle mass will be measured (in kg) to monitor rate of muscle hypertrophy/atrophy over rehabilitation timeline.
Measured: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA)
Muscle mass, bone mass, and body fluid (kg/m2) will be measured to contribute to Body Mass Index (BMI) scores.
Measured: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA)
Fat mass (kg/m2) will be measured to contribute to body mass index (BMI) scores.
Measured: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS)
The KOOS is a self-reported outcome measure assessing the patient's perspective about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, activities of daily living, function in sports/recreation, and quality of life. A likert scale is used and all items have five possible answers ranging from 0 (no problems) to 4 (extreme problems). The five subscale scores are calculated as the sum of the items for each subscale. Scores are then transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.
Measured: pre-operative, 3, 6, 9, 12 months post-operative
Change in knee pain and function assessed by the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
The IKDC is a self-reported outcome measure that assesses knee disability and function before and after treatment. It consists of 18 items that measure symptoms, function, and sports activity. Response types include 5-point Likert Scales, 11-point Likert scales, and dichotomous "yes-no" responses.
Measured: pre-operative, 3, 6, 9, 12 months post-operative
Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29)
PROMIS-29 is a self-reported outcome measure assessing for the patient's pain intensity. It is a 28-item questionnaire, which includes 7 subscales of four items each: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. A likert scale is used for all domain response scales, however they vary in responses.
Measured: pre-operative, 3, 6, 9, 12 months post-operative
Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE)
Participants will provide a numerical rating from 0 (least normal) to 100 (most normal) of the perceived improvement in knee health in relation to their pre-injury baseline.
Measured: pre-operative, 3, 6, 9, 12 months post-operative
Change in knee function assessed by the Marx Activity Rating Scale (MARS)
MARS includes 4 items that assess the frequency of running, cutting, decelerating, and pivoting based on the subjects "healthiest and most active state in the past year". Each item is scored on a 5-point ordinal scale ranging from 0 (less than 1 time in a month) to 4 (4 or more times in a week), and the total scale score is obtained by summing the individual items' scores (range, 0-16). A higher score indicates more functional demand on the knee joint and potentially a higher risk of injury.
Measured: pre-operative, 3, 6, 9, 12 months post-operative
Impact of ACL surgery on overall quality of life assessed by the Anterior Cruciate Ligament-Quality of Life (ACL-QOL)
The questionnaire consists of 32 equally weighted questions that are answered using a 100 mm visual analog scale and is scored of 100. It comprises 5 domains, including (1) symptoms and physical complaints (5 items); (2) work-related concerns (4 items); (3) recreational activity and sport participation or competition (12 items); (4) lifestyle (6 items); and (5) social and emotional (5 items).
Measured: pre-operative, 3, 6, 9, 12 months post-operative
Change of running gait function from the patients' perspective assessed by the University of Wisconsin Running Injury and Recovery Index (UWRI)
The 9-item UWRI assesses running ability following a running related injury, with the maximum score of 36 indicating a return to preinjury running ability.
Measured: pre-operative, 3, 6, 9, 12 months post-operative
Change of knee pain from the patients' perspective assessed by the Visual Analog Scale (VAS)
Will measure average knee pain over a given timeframe from 0 to 10 cm visual analogue scale where 0 cm equals no pain and 10 cm indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
Measured: Weekly from 1-week post-operative until 3 months; monthly from 4-12 months
Time to return to full duty
Measured by the time from post-operative timepoint to time of full clearance for military tasks
Measured: 12 months post-operative
Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring peak isometric knee extensor torque.
Peak isometric extensor torque (nm/kg).
Measured: At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.
Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring knee extensor rate of torque development.
Rate of torque development (nm/s)
Measured: At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start19 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Collaborators
- Medical Technology Enterprise Consortium
- Responsible party
- Principal investigator, Shawn Gee, MD, Keller Army Community Hospital
- Investigators
- Shawn M Gee, MD, Principal investigator, Keller Army Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341868
- Sponsor's protocol ID
- KACH.2023.0067
- Other IDs
- 23KACH008
- Status last verified
- Dec 2025
- First submitted
- 18 Mar 2024
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: all individual participant data (IPD) that underlie results in a publication.
Publications
Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
PubMed 14613558Jacobson RP, Kang D, Houck J. Can Patient-Reported Outcomes Measurement Information System(R) (PROMIS) measures accurately enhance understanding of acceptable symptoms and functioning in primary care? J Patient Rep Outcomes. 2020 May 20;4(1):39. doi: 10.1186/s41687-020-00206-9.
PubMed 32436001O'Connor CM, Ring D. Correlation of Single Assessment Numeric Evaluation (SANE) with other Patient Reported Outcome Measures (PROMs). Arch Bone Jt Surg. 2019 Jul;7(4):303-306.
PubMed 31448305Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
PubMed 30211382Marx RG, Stump TJ, Jones EC, Wickiewicz TL, Warren RF. Development and evaluation of an activity rating scale for disorders of the knee. Am J Sports Med. 2001 Mar-Apr;29(2):213-8. doi: 10.1177/03635465010290021601.
PubMed 11292048Winterstein AP, McGuine TA, Carr KE, Hetzel SJ. Comparison of IKDC and SANE Outcome Measures Following Knee Injury in Active Female Patients. Sports Health. 2013 Nov;5(6):523-9. doi: 10.1177/1941738113499300.
PubMed 24427427Cobian DG, Koch CM, Amendola A, Williams GN. Knee Extensor Rate of Torque Development Before and After Arthroscopic Partial Meniscectomy, With Analysis of Neuromuscular Mechanisms. J Orthop Sports Phys Ther. 2017 Dec;47(12):945-956. doi: 10.2519/jospt.2017.7310. Epub 2017 Oct 9.
PubMed 28992769Kline PW, Morgan KD, Johnson DL, Ireland ML, Noehren B. Impaired Quadriceps Rate of Torque Development and Knee Mechanics After Anterior Cruciate Ligament Reconstruction With Patellar Tendon Autograft. Am J Sports Med. 2015 Oct;43(10):2553-8. doi: 10.1177/0363546515595834. Epub 2015 Aug 14.
PubMed 26276828Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.
PubMed 17888709Hill OT, Bulathsinhala L, Scofield DE, Haley TF, Bernasek TL. Risk factors for soft tissue knee injuries in active duty U.S. Army soldiers, 2000-2005. Mil Med. 2013 Jun;178(6):676-82. doi: 10.7205/MILMED-D-13-00049.
PubMed 23756076Lepley LK, Davi SM, Burland JP, Lepley AS. Muscle Atrophy After ACL Injury: Implications for Clinical Practice. Sports Health. 2020 Nov/Dec;12(6):579-586. doi: 10.1177/1941738120944256. Epub 2020 Aug 31.
PubMed 32866081Aguero AD, Irrgang JJ, MacGregor AJ, Rothenberger SD, Hart JM, Fraser JJ. Sex, military occupation and rank are associated with risk of anterior cruciate ligament injury in tactical-athletes. BMJ Mil Health. 2023 Nov 22;169(6):535-541. doi: 10.1136/bmjmilitary-2021-002059.
PubMed 35165197Hauret KG, Jones BH, Bullock SH, Canham-Chervak M, Canada S. Musculoskeletal injuries description of an under-recognized injury problem among military personnel. Am J Prev Med. 2010 Jan;38(1 Suppl):S61-70. doi: 10.1016/j.amepre.2009.10.021.
PubMed 20117601Molloy JM, Pendergrass TL, Lee IE, Hauret KG, Chervak MC, Rhon DI. Musculoskeletal Injuries and United States Army Readiness. Part II: Management Challenges and Risk Mitigation Initiatives. Mil Med. 2020 Sep 18;185(9-10):e1472-e1480. doi: 10.1093/milmed/usaa028.
PubMed 32107561Levine M, McElroy K, Stakich V, Cicco J. Comparing conventional physical therapy rehabilitation with neuromuscular electrical stimulation after TKA. Orthopedics. 2013 Mar;36(3):e319-24. doi: 10.3928/01477447-20130222-20.
PubMed 23464951
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Gait-Synchronous Neuromuscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06341868
- Acronym / sponsor ID
- KACH.2023.0067
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- knee, Anterior Cruciate Ligament, Gait, Neuromuscular electric stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Collaborators
- Medical Technology Enterprise Consortium
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care + KneeStim controlled low intensity | Sham comparator | Device: KneeStimLow intensity range |
| Standard of Care + KneeStim flexible intensity | Experimental | Device: KneeStimFlexible to high intensity range |
Who may qualify
- Ages
- 17 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- United States Military Academy cadet between ages of 17-27 years
- Undergoing a Primary ACL Reconstruction, or Revision ACL Reconstruction
Key exclusion criteria (6 listed)
- Concomitant or prior high tibial osteotomy (HTO)
- Concomitant or prior cartilage restoration procedure
- Concomitant ligamentous reconstruction (lateral collateral ligament; posterior cruciate ligament; medial collateral ligament)
- Contraindications to using the KneeStim device
- Any meniscus tear precluding weight bearing for 6 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KneeStimParticipant will be randomized to either be in control or experimental group | Device | Standard of Care + KneeStim controlled low intensity, Standard of Care + KneeStim flexible intensity |
Primary outcome
Change in gait post-operatively assessed by the KneeStimTM Device
Time frame: 6 weeks;3, 6, 9, 12 months post-operative
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)
19 secondary outcomes
change in gait post-operatively assessed by 3D Motion capture
Time frame: 3, 6, 9, 12 months post-operative
change in gait post-operatively assessed by force plate instrumented treadmill
Time frame: 3, 6, 9, 12 months post-operative
change in muscle volume assessed by MRI
Time frame: pre-operative, 3, 6, 9, 12 months post-operative
ACL graft healing assessed by MRI
Time frame: pre-operative, 3, 6, 9, 12 months post-operative
Change in isometric muscle strength assessed by CSMi HUMAC NORM
Time frame: 3, 6, 9, 12 months post-operative
Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA)
Time frame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA)
Time frame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA)
Time frame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS)
Time frame: pre-operative, 3, 6, 9, 12 months post-operative
Change in knee pain and function assessed by the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
Time frame: pre-operative, 3, 6, 9, 12 months post-operative
Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29)
Time frame: pre-operative, 3, 6, 9, 12 months post-operative
Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE)
Time frame: pre-operative, 3, 6, 9, 12 months post-operative
Change in knee function assessed by the Marx Activity Rating Scale (MARS)
Time frame: pre-operative, 3, 6, 9, 12 months post-operative
Impact of ACL surgery on overall quality of life assessed by the Anterior Cruciate Ligament-Quality of Life (ACL-QOL)
Time frame: pre-operative, 3, 6, 9, 12 months post-operative
Change of running gait function from the patients' perspective assessed by the University of Wisconsin Running Injury and Recovery Index (UWRI)
Time frame: pre-operative, 3, 6, 9, 12 months post-operative
Change of knee pain from the patients' perspective assessed by the Visual Analog Scale (VAS)
Time frame: Weekly from 1-week post-operative until 3 months; monthly from 4-12 months
Time to return to full duty
Time frame: 12 months post-operative
Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring peak isometric knee extensor torque.
Time frame: At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.
Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring knee extensor rate of torque development.
Time frame: At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Background: PubMed 14613558Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
- Background: PubMed 32436001Jacobson RP, Kang D, Houck J. Can Patient-Reported Outcomes Measurement Information System(R) (PROMIS) measures accurately enhance understanding of acceptable symptoms and functioning in primary care? J Patient Rep Outcomes. 2020 May 20;4(1):39. doi: 10.1186/s41687-020-00206-9.
- Background: PubMed 31448305O'Connor CM, Ring D. Correlation of Single Assessment Numeric Evaluation (SANE) with other Patient Reported Outcome Measures (PROMs). Arch Bone Jt Surg. 2019 Jul;7(4):303-306.
- Background: PubMed 30211382Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
- Background: PubMed 11292048Marx RG, Stump TJ, Jones EC, Wickiewicz TL, Warren RF. Development and evaluation of an activity rating scale for disorders of the knee. Am J Sports Med. 2001 Mar-Apr;29(2):213-8. doi: 10.1177/03635465010290021601.
- Background: PubMed 24427427Winterstein AP, McGuine TA, Carr KE, Hetzel SJ. Comparison of IKDC and SANE Outcome Measures Following Knee Injury in Active Female Patients. Sports Health. 2013 Nov;5(6):523-9. doi: 10.1177/1941738113499300.
- Background: PubMed 28992769Cobian DG, Koch CM, Amendola A, Williams GN. Knee Extensor Rate of Torque Development Before and After Arthroscopic Partial Meniscectomy, With Analysis of Neuromuscular Mechanisms. J Orthop Sports Phys Ther. 2017 Dec;47(12):945-956. doi: 10.2519/jospt.2017.7310. Epub 2017 Oct 9.
- Background: PubMed 26276828Kline PW, Morgan KD, Johnson DL, Ireland ML, Noehren B. Impaired Quadriceps Rate of Torque Development and Knee Mechanics After Anterior Cruciate Ligament Reconstruction With Patellar Tendon Autograft. Am J Sports Med. 2015 Oct;43(10):2553-8. doi: 10.1177/0363546515595834. Epub 2015 Aug 14.
- Background: PubMed 17888709Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.
- Background: PubMed 23756076Hill OT, Bulathsinhala L, Scofield DE, Haley TF, Bernasek TL. Risk factors for soft tissue knee injuries in active duty U.S. Army soldiers, 2000-2005. Mil Med. 2013 Jun;178(6):676-82. doi: 10.7205/MILMED-D-13-00049.
- Background: PubMed 32866081Lepley LK, Davi SM, Burland JP, Lepley AS. Muscle Atrophy After ACL Injury: Implications for Clinical Practice. Sports Health. 2020 Nov/Dec;12(6):579-586. doi: 10.1177/1941738120944256. Epub 2020 Aug 31.
- Background: PubMed 35165197Aguero AD, Irrgang JJ, MacGregor AJ, Rothenberger SD, Hart JM, Fraser JJ. Sex, military occupation and rank are associated with risk of anterior cruciate ligament injury in tactical-athletes. BMJ Mil Health. 2023 Nov 22;169(6):535-541. doi: 10.1136/bmjmilitary-2021-002059.
- Individual participant dataSharing planned: Yes. all individual participant data (IPD) that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shawn M Gee, MD principal investigator
Keller Army Community Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KneeStim in people with Anterior Cruciate Ligament Injuries, run by Keller Army Community Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia B Prando, MA (315-774-8368, natalia.b.prando.ctr@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait post-operatively assessed by the KneeStimTM Device (time frame: 6 weeks;3, 6, 9, 12 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06341868, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.