NCT06259968 Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial
| NCT ID | NCT06259968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of Health Science of Porto Alegre |
| Condition | Anterior Cruciate Ligament Reconstruction Rehabilitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-05-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06259968 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Anterior Cruciate Ligament Reconstruction Rehabilitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06259968 currently recruiting?
Yes, NCT06259968 is actively recruiting participants. Contact the research team at gabriela.gasparin@hotmail.com for enrollment information.
Where is the NCT06259968 trial being conducted?
This trial is being conducted at Veranópolis, Brazil, Veranópolis, Brazil.
Who is sponsoring the NCT06259968 clinical trial?
NCT06259968 is sponsored by Federal University of Health Science of Porto Alegre. The trial plans to enroll 40 participants.