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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Maximal isometric strength of knee extensors [Срок оценки: Before surgery and 30 days post-surgery.]

Вторичные конечные точки (6)

• Joint range of motion [Срок оценки: Before surgery, and then at 2, 15, and 30 days post-surgery.]
• Self-reported functional impairments [Срок оценки: Before surgery, and then at 2, 15, and 30 days post-surgery.]
• Quadriceps activation status [Срок оценки: Before surgery, and then at 2, 15, and 30 days post-surgery.]
• Muscle atrophy [Срок оценки: Before surgery, and then at 2, 15, and 30 days post-surgery.]
• Knee edema [Срок оценки: Before surgery, and then at 2, 15, and 30 days post-surgery.]
• Knee pain [Срок оценки: Before surgery, and then at 2, 15, and 30 days post-surgery.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 2 центра

• Private Rehabilitation Center — Veranópolis
• Private Rehabilitation Center — Veranópolis

Идентификаторы

NCT: NCT06259968 · 76203223.0.0000.5345

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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