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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Apr 1, 2024 to May 1, 2024
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06259968
Lead Sponsor Federal University of Health Science of Porto Alegre
Conditions
(from sponsor)		 Anterior Cruciate Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov