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

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06259968
• Other study ID #: 76203223.0.0000.5345
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Federal University of Health Science of Porto Alegre
• Contact: Gabriela Bissani Gasparin
• Phone: +5554991296689
• Email: gabriela.gasparin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Device:
• Neuromuscular electrical stimulation
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
Patients will be instructed to perform maximum voluntary contractions superimposed on neuromuscular electrical stimulation

Locations

Country	Name	City	State
Brazil	Private Rehabilitation Center	Veranópolis	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal isometric strength of knee extensors	Assessed by manual isometric dynamometry	Before surgery and 30 days post-surgery.
Secondary	Joint range of motion	Joint range of motion will be assessed using heel-height measurement and goniometry	Before surgery, and then at 2, 15, and 30 days post-surgery.
Secondary	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)	Before surgery, and then at 2, 15, and 30 days post-surgery.
Secondary	Quadriceps activation status	The quadriceps activation status will be assessed by lag sign.	Before surgery, and then at 2, 15, and 30 days post-surgery.
Secondary	Muscle atrophy	The evaluation of muscle atrophy will be performed by measuring the circumference of the thigh.	Before surgery, and then at 2, 15, and 30 days post-surgery.
Secondary	Knee edema	Joint swelling will be assessed using the Stroke Test.	Before surgery, and then at 2, 15, and 30 days post-surgery.
Secondary	Knee pain	The severity of knee pain will be assessed through the numerical pain rating scale.	Before surgery, and then at 2, 15, and 30 days post-surgery.