NCT06259968

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Federal University of Health Science of Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Anterior Cruciate Ligament Reconstruction Rehabilitation
• Anterior Cruciate Ligament Reconstruction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-02-14
• Last updated: 2025-04-01

Locations

2 sites across 1 country: Brazil