NCT07015541

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
27mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

2.3 years

First QC Date

June 3, 2025

Last Update Submit

July 22, 2026

Conditions

ACL Tear

Outcome Measures

Primary Outcomes (2)

  • Peak force as measured by isometric knee extension force test

    Isometric knee extension force will be measured with a dynamometer.

    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

    12 and 16 weeks post surgery

Secondary Outcomes (3)

  • Sagittal plane peak angle at the hip during the descending phase of the squat

    12 and 16 weeks post surgery

  • Sagittal plane peak angle at the knee during the descending phase of the squat

    12 and 16 weeks post surgery

  • Sagittal plane peak angle at the ankle during the descending phase of the squat

    12 and 16 weeks post surgery

Study Arms (1)

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.

Other: NMES and BFROther: Standard physical therapy

Interventions

NMES and BFROTHER

NMES is applied when patients perform quadriceps strengthening exercises. BFR is applied during compound exercises.

Additional neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR)
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.

Additional neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR)

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • no history of knee injury/surgery of the contralateral limb

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Medicine Children's Health

Sunnyvale, California, 94087, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 12635796BACKGROUND

  • Kim 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.

    PMID: 20592480BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Alexandra M Abbott, MD

    Stanford School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor (Orthopedic Surgery)

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 11, 2025

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)