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

NCT06259968 | Recruiting

• 1 other identifier: 76203223.0.0000.5345
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation; Anterior Cruciate Ligament Reconstruction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximal isometric strength of knee extensors

  Assessed by manual isometric dynamometry

  Before surgery and 30 days post-surgery.

Secondary Outcomes (6)

• Joint range of motion

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

• Self-reported functional impairments

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

• Quadriceps activation status

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

• Muscle atrophy

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

• Knee edema

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

Study Arms (2)

NMES+

EXPERIMENTAL

Neuromuscular electrical stimulation with superimposed voluntary contraction

Device: Neuromuscular electrical stimulation with superimposed voluntary contraction

NMES

ACTIVE COMPARATOR

Neuromuscular electrical stimulation without voluntary contraction

Device: Neuromuscular electrical stimulation

Interventions

Neuromuscular electrical stimulation DEVICE

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

Also known as: NMES

NMES

Neuromuscular electrical stimulation with superimposed voluntary contraction DEVICE

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

Also known as: NMES +

NMES+

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (2)

Private Rehabilitation Center

Veranópolis, Rio Grande do Sul, 95330000, Brazil

NOT YET RECRUITING

Private Rehabilitation Center

Veranópolis, Rio Grande do Sul, 95330000, Brazil

RECRUITING

Central Study Contacts

Gabriela Bissani Gasparin

CONTACT

+5554991296689; gabriela.gasparin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 14, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)