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

February 7, 2024 updated by: Bruno Manfredini Baroni, Federal University of Health Science of Porto Alegre

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • RS
      • Veranópolis, RS, Brazil, 95330000
        • Private Rehabilitation Center
        • Contact:
          • Gabariela Bissani Gasparin
          • Phone Number: +5554991296689
        • Principal Investigator:
          • Gabriela Bissani Gasparin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NMES+
Neuromuscular electrical stimulation with superimposed voluntary contraction
Device: Neuromuscular electrical stimulation with superimposed voluntary contraction
Patients will be instructed to perform maximum voluntary contractions superimposed on neuromuscular electrical stimulation
Other Names:
  • NMES +
Active Comparator: NMES
Neuromuscular electrical stimulation without voluntary contraction
Device: Neuromuscular electrical stimulation
Patients in the neuromuscular electrical stimulation group will receive neuromuscular electrical stimulation without the concomitant execution of voluntary quadriceps contraction
Other Names:
  • NMES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal isometric strength of knee extensors
Time Frame: Before surgery and 30 days post-surgery.
Assessed by manual isometric dynamometry
Before surgery and 30 days post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint range of motion
Time Frame: Before surgery, and then at 2, 15, and 30 days post-surgery.
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.
Self-reported functional impairments
Time Frame: Before 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)
Before surgery, and then at 2, 15, and 30 days post-surgery.
Quadriceps activation status
Time Frame: Before surgery, and then at 2, 15, and 30 days post-surgery.
The quadriceps activation status will be assessed by lag sign.
Before surgery, and then at 2, 15, and 30 days post-surgery.
Muscle atrophy
Time Frame: Before 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.
Before surgery, and then at 2, 15, and 30 days post-surgery.
Knee edema
Time Frame: Before surgery, and then at 2, 15, and 30 days post-surgery.
Joint swelling will be assessed using the Stroke Test.
Before surgery, and then at 2, 15, and 30 days post-surgery.
Knee pain
Time Frame: Before 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.
Before surgery, and then at 2, 15, and 30 days post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 76203223.0.0000.5345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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