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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorFederal University of Health Science of Porto Alegre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Neuromuscular electrical stimulation

    Device

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

  • Neuromuscular electrical stimulation with superimposed voluntary contraction

    Device

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: NMES+Experimental treatment 1 intervention
Group B: NMESActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximal isometric strength of knee extensors

Assessed by manual isometric dynamometry

Time frame
Before surgery and 30 days post-surgery.

Secondary outcomes

1

Joint range of motion

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

Time frame
Before surgery, and then at 2, 15, and 30 days post-surgery.
2

Self-reported functional impairments

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

Time frame
Before surgery, and then at 2, 15, and 30 days post-surgery.
3

Quadriceps activation status

The quadriceps activation status will be assessed by lag sign.

Time frame
Before surgery, and then at 2, 15, and 30 days post-surgery.
4

Muscle atrophy

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

Time frame
Before surgery, and then at 2, 15, and 30 days post-surgery.

Other outcomes

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