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Recruiting NCT07015541

Quadriceps Strengthening ACL Reconstruction

No phase Interventional ACL Tear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NMES and BFR, Standard physical therapy.
Who it may be relevant to
Registry conditions: ACL Tear. Basic parameters: 13 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Quadriceps Focused Interventions in Adolescent With ACL Reconstruction

Overview

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

Interventions

  • Other NMES and BFR
    NMES is applied when patients perform quadriceps strengthening exercises. BFR is applied during compound exercises.
  • Other Standard physical therapy
    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.

Primary outcome measures

  • Peak force as measured by isometric knee extension force test [Time frame: 12 and 16 weeks post surgery]
  • Force steadiness as measured by isometric knee extension force test [Time frame: 12 and 16 weeks post surgery]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • (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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford Medicine Children's Health — Sunnyvale

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. PMID 12635796
  • 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 20592480

Identifiers

NCT: NCT07015541 · 80260

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗