ACL TearACLNCT07015541
Quadriceps Strengthening ACL Reconstruction
A study testing NMES and BFR and Standard physical therapy in people with ACL Tear, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to characterize quadriceps function and squat biomechanics during the early strengthening phase in adolescent patients undergoing a standardized combined neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR) rehabilitation protocol Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- ACL Tear
- What is being tested?
- NMES and BFR and Standard physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2026to Nov 2028
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- no history of knee injury/surgery of the contralateral limb
Who cannot join
- (1) bilateral knee injuries
- (2) prior knee ligament injury and/or surgery
- (3) multiple ligament injuries and/or ruptures
- (4) conditions in which NMES and BFR are contraindicated
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
Stanford Medicine Children's Health
Sunnyvale, California, 94087
Chao-Jung Hsu, PhD, 650-313-1808, ChaHsu@stanfordchildrens.org
Jeffery Morgan, MS, 650-313-1808, jemorgan@stanford.edu
About this study
Official title: Effects of Quadriceps Focused Interventions in Adolescent With ACL Reconstruction
The purpose of this study is to characterize quadriceps function and squat biomechanics during the early strengthening phase in adolescent patients undergoing a standardized combined neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR) rehabilitation protocol
- Conditions
- ACL Tear
- Being tested
- NMES and BFR, Standard physical therapy
- 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.
NMES and BFROther
NMES is applied when patients perform quadriceps strengthening exercises. BFR is applied during compound exercises.
Standard physical therapyOther
Standard physical therapy (week 1-16) includes interventions for typical impairments following ACLR. The initial phase will focus on pain and effusion control, restoration of knee range of motion, followed by gait normalization, lower extremity strength training, then running and plyometrics.
| Study group | Role | What they receive |
|---|---|---|
| Additional neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR) | Experimental | Participants receive a 6-week NMES intervention from week 1 to week 6 post-surgery, followed by a 10-week BFR intervention from week 7 to week 16. Participants also receive standard rehabilitation care as part of their routine postsurgical recovery process. Receives: Other: NMES and BFR; Other: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak force as measured by isometric knee extension force test
Isometric knee extension force will be measured with a dynamometer.
Measured: 12 and 16 weeks post surgery
Force steadiness as measured by isometric knee extension force test
Isometric knee extension force will be measured with a dynamometer
Measured: 12 and 16 weeks post surgery
Secondary outcomes (3)
Sagittal plane peak angle at the hip during the descending phase of the squat
Motion analysis will be conducted using the cloud-based OpenCap application
Measured: 12 and 16 weeks post surgery
Sagittal plane peak angle at the knee during the descending phase of the squat
Motion analysis will be conducted using the cloud-based OpenCap application
Measured: 12 and 16 weeks post surgery
Sagittal plane peak angle at the ankle during the descending phase of the squat
Motion analysis will be conducted using the cloud-based OpenCap application
Measured: 12 and 16 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start29 Sep 2026
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ACL TearStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Abbott, Stanford University
- Investigators
- Alexandra M Abbott, MD, Principal investigator, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015541
- Sponsor's protocol ID
- 80260
- Acronym
- ACL
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.
PubMed 12635796Kim KM, Croy T, Hertel J, Saliba S. Effects of neuromuscular electrical stimulation after anterior cruciate ligament reconstruction on quadriceps strength, function, and patient-oriented outcomes: a systematic review. J Orthop Sports Phys Ther. 2010 Jul;40(7):383-91. doi: 10.2519/jospt.2010.3184.
PubMed 20592480
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Quadriceps Focused Interventions in Adolescent With ACL Reconstruction
- ClinicalTrials.gov ID
- NCT07015541
- Acronym / sponsor ID
- ACL / 80260
- Conditions
- ACL Tear
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 29 Sep 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 11 Jun 2025 (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 purpose of this study is to characterize quadriceps function and squat biomechanics during the early strengthening phase in adolescent patients undergoing a standardized combined neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR) rehabilitation protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR) | Experimental | Other: NMES and BFR, Other: Standard physical therapyParticipants receive a 6-week NMES intervention from week 1 to week 6 post-surgery, followed by a 10-week BFR intervention from week 7 to week 16. Participants also receive standard rehabilitation care as part of their routine postsurgical recovery process. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- no history of knee injury/surgery of the contralateral limb
Key exclusion criteria (4 listed)
- (1) bilateral knee injuries
- (2) prior knee ligament injury and/or surgery
- (3) multiple ligament injuries and/or ruptures
- (4) conditions in which NMES and BFR are contraindicated
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 |
|---|---|---|
| NMES and BFRNMES is applied when patients perform quadriceps strengthening exercises. BFR is applied during compound exercises. | Other | Additional neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR) |
| Standard physical therapyStandard physical therapy (week 1-16) includes interventions for typical impairments following ACLR. The initial phase will focus on pain and effusion control, restoration of knee range of motion, followed by gait normalization, lower extremity strength training, then running and plyometrics. | Other | Additional neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR) |
Primary outcome
Peak force as measured by isometric knee extension force test
Time frame: 12 and 16 weeks post surgery
Isometric knee extension force will be measured with a dynamometer.
Force steadiness as measured by isometric knee extension force test
Time frame: 12 and 16 weeks post surgery
Isometric knee extension force will be measured with a dynamometer
3 secondary outcomes
Sagittal plane peak angle at the hip during the descending phase of the squat
Time frame: 12 and 16 weeks post surgery
Sagittal plane peak angle at the knee during the descending phase of the squat
Time frame: 12 and 16 weeks post surgery
Sagittal plane peak angle at the ankle during the descending phase of the squat
Time frame: 12 and 16 weeks post surgery
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 15 Oct 2026.
- Background: PubMed 12635796Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.
- Background: PubMed 20592480Kim KM, Croy T, Hertel J, Saliba S. Effects of neuromuscular electrical stimulation after anterior cruciate ligament reconstruction on quadriceps strength, function, and patient-oriented outcomes: a systematic review. J Orthop Sports Phys Ther. 2010 Jul;40(7):383-91. doi: 10.2519/jospt.2010.3184.
- Individual participant dataSharing planned: No
Related trials for ACL Tear
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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.
Alexandra M Abbott, MD principal investigator
Stanford School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES and BFR and Standard physical therapy in people with ACL Tear, run by Stanford University 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 1 inclusion and 4 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 15 Oct 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak force as measured by isometric knee extension force test (time frame: 12 and 16 weeks post surgery). The study lists 2 primary outcomes in all. 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 NCT07015541, which also lists 2 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 15 Oct 2026.