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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06259968
Enrollment
40
Registered
2024-02-14
Start date
2024-05-01
Completion date
2026-12-31
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Reconstruction Rehabilitation

Keywords

Neuromuscular Electrical Stimulation, Knee, Physiotherapy, Quadriceps, Anterior cruciate ligament reconstruction

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.

Interventions

DEVICENeuromuscular electrical stimulation

Patients in the neuromuscular electrical stimulation group will receive neuromuscular electrical stimulation without the concomitant execution of voluntary quadriceps contraction

DEVICENeuromuscular electrical stimulation with superimposed voluntary contraction

Patients will be instructed to perform maximum voluntary contractions superimposed on neuromuscular electrical stimulation

Sponsors

Federal University of Health Science of Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Maximal isometric strength of knee extensorsBefore surgery and 30 days post-surgery.Assessed by manual isometric dynamometry

Secondary

MeasureTime frameDescription
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)
Quadriceps activation statusBefore surgery, and then at 2, 15, and 30 days post-surgery.The quadriceps activation status will be assessed by lag sign.
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
Knee edemaBefore surgery, and then at 2, 15, and 30 days post-surgery.Joint swelling will be assessed using the Stroke Test.
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.
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.

Countries

Brazil

Contacts

Primary ContactGabriela Bissani Gasparin
gabriela.gasparin@hotmail.com+5554991296689

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026