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

F

Federal University of Health Science of Porto Alegre

Status

Enrolling

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation
Anterior Cruciate Ligament Reconstruction

Treatments

Device: Neuromuscular electrical stimulation with superimposed voluntary contraction
Device: Neuromuscular electrical stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06259968
76203223.0.0000.5345

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

NMES+
Experimental group
Description:
Neuromuscular electrical stimulation with superimposed voluntary contraction
Treatment:
Device: Neuromuscular electrical stimulation with superimposed voluntary contraction
NMES
Active Comparator group
Description:
Neuromuscular electrical stimulation without voluntary contraction
Treatment:
Device: Neuromuscular electrical stimulation

Trial contacts and locations

1

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Central trial contact

Gabriela Bissani Gasparin

Data sourced from clinicaltrials.gov

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