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Clinical Trials/NCT06259968
NCT06259968
Recruiting
Not Applicable

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

Federal University of Health Science of Porto Alegre1 site in 1 country40 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Reconstruction Rehabilitation
Sponsor
Federal University of Health Science of Porto Alegre
Enrollment
40
Locations
1
Primary Endpoint
Maximal isometric strength of knee extensors
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Health Science of Porto Alegre
Responsible Party
Principal Investigator
Principal Investigator

Bruno Manfredini Baroni

PhD

Federal University of Health Science of Porto Alegre

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.

Outcomes

Primary Outcomes

Maximal isometric strength of knee extensors

Time Frame: Before surgery and 30 days post-surgery.

Assessed by manual isometric dynamometry

Secondary Outcomes

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

Study Sites (1)

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