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

NCT ID: NCT06259968

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Reconstruction Rehabilitation Anterior Cruciate Ligament Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NMES+

Neuromuscular electrical stimulation with superimposed voluntary contraction

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation with superimposed voluntary contraction

Intervention Type DEVICE

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

NMES

Neuromuscular electrical stimulation without voluntary contraction

Group Type ACTIVE_COMPARATOR

Neuromuscular electrical stimulation

Intervention Type DEVICE

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

Interventions

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Neuromuscular electrical stimulation

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

Intervention Type DEVICE

Neuromuscular electrical stimulation with superimposed voluntary contraction

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

Intervention Type DEVICE

Other Intervention Names

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NMES NMES +

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Bruno Manfredini Baroni

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Private Rehabilitation Center

VeranĂ³polis, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Private Rehabilitation Center

VeranĂ³polis, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Gabriela Bissani Gasparin

Role: CONTACT

+5554991296689

Facility Contacts

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Gabariela Bissani Gasparin

Role: primary

+5554991296689

Gabariela Bissani Gasparin

Role: primary

54991296689

Other Identifiers

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76203223.0.0000.5345

Identifier Type: -

Identifier Source: org_study_id

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