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

Not Applicable
Recruiting
Conditions
Anterior Cruciate Ligament Reconstruction Rehabilitation
Anterior Cruciate Ligament Reconstruction
Interventions
Device: Neuromuscular electrical stimulation with superimposed voluntary contraction
Device: Neuromuscular electrical stimulation
Registration Number
NCT06259968
Lead Sponsor
Federal University of Health Science of Porto Alegre
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
NMES+Neuromuscular electrical stimulation with superimposed voluntary contractionNeuromuscular electrical stimulation with superimposed voluntary contraction
NMESNeuromuscular electrical stimulationNeuromuscular electrical stimulation without voluntary contraction
Primary Outcome Measures
NameTimeMethod
Maximal isometric strength of knee extensorsBefore surgery and 30 days post-surgery.

Assessed by manual isometric dynamometry

Secondary Outcome Measures
NameTimeMethod
Quadriceps activation statusBefore surgery, and then at 2, 15, and 30 days post-surgery.

The quadriceps activation status will be assessed by lag sign.

Knee edemaBefore surgery, and then at 2, 15, and 30 days post-surgery.

Joint swelling will be assessed using the Stroke Test.

Joint range of motionBefore surgery, and then at 2, 15, and 30 days post-surgery.

Joint range of motion will be assessed using heel-height measurement and goniometry

Self-reported functional impairmentsBefore surgery, and then at 2, 15, and 30 days post-surgery.

Self-reported functional impairments will be assessed using Lysholm Scale and the Knee Outcome Survey-Activities of Daily Living Scale (KOS-ADLS)

Muscle atrophyBefore surgery, and then at 2, 15, and 30 days post-surgery.

The evaluation of muscle atrophy will be performed by measuring the circumference of the thigh.

Knee painBefore surgery, and then at 2, 15, and 30 days post-surgery.

The severity of knee pain will be assessed through the numerical pain rating scale.

Trial Locations

Locations (1)

Private Rehabilitation Center

🇧🇷

Veranópolis, RS, Brazil

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