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Recruiting NCT06259968

Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial

No phase Interventional Anterior Cruciate Ligament Reconstruction Rehabilitation Anterior Cruciate Ligament Reconstruction

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: Neuromuscular electrical stimulation, Neuromuscular electrical stimulation with superimposed voluntary contraction.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction. Basic parameters: 18 years — 40 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
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This study aims to evaluate the effectiveness of neuromuscular electrical stimulation with superimposed voluntary contraction (NMES+ group) compared to NMES without voluntary contraction (NMES group) during the initial month of rehabilitation post anterior cruciate ligament reconstruction (ACLR). Forty patients will be randomly assigned to either the NMES group or the NMES+ group. Both groups will follow an identical rehabilitation regimen in the first month after surgery, which includes interventions for symptom management, inflammation control, edema reduction, improved joint motion range, and restoration of muscle function. All participants will undergo identical assessment protocols at four time points: pre-surgery evaluation, and assessments at 2, 15, and 30 days post-ACLR. The primary outcome of the study is the maximal isometric strength of knee extensors. Secondary outcomes encompass thigh muscle atrophy, self-reported functional impairments, knee pain, knee edema, joint range of motion, and quadriceps activation status.

Interventions

  • Device Neuromuscular electrical stimulation
    Patients in the neuromuscular electrical stimulation group will receive neuromuscular electrical stimulation without the concomitant execution of voluntary quadriceps contraction
  • Device Neuromuscular electrical stimulation with superimposed voluntary contraction
    Patients will be instructed to perform maximum voluntary contractions superimposed on neuromuscular electrical stimulation

Primary outcome measures

  • Maximal isometric strength of knee extensors [Time frame: Before surgery and 30 days post-surgery.]
Secondary outcome measures (6)
  • Joint range of motion [Time frame: Before surgery, and then at 2, 15, and 30 days post-surgery.]
  • Self-reported functional impairments [Time frame: Before surgery, and then at 2, 15, and 30 days post-surgery.]
  • Quadriceps activation status [Time frame: Before surgery, and then at 2, 15, and 30 days post-surgery.]
  • Muscle atrophy [Time frame: Before surgery, and then at 2, 15, and 30 days post-surgery.]
  • Knee edema [Time frame: Before surgery, and then at 2, 15, and 30 days post-surgery.]
  • Knee pain [Time frame: Before surgery, and then at 2, 15, and 30 days post-surgery.]

Eligibility criteria

Inclusion criteria

\- Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.

Exclusion criteria

  • Failure to attend the pre-surgery assessment session;
  • Delay of more than 7 days after surgery to initiate the rehabilitation program proposed by the study;
  • Presence of injuries related to the rupture of the ACL that hinder partial weight-bearing in the first week after surgery, either due to medical recommendation or the patient inability/disposition.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Brazil · 2 centers
  • Private Rehabilitation Center — Veranópolis
  • Private Rehabilitation Center — Veranópolis

Identifiers

NCT: NCT06259968 · 76203223.0.0000.5345

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗