Evaluating electrical stimulation methods after ACL reconstruction
Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial
NA · Federal University of Health Science of Porto Alegre · NCT06259968
This study is testing whether combining electrical stimulation with voluntary muscle contractions helps people recover better after knee surgery compared to just using electrical stimulation alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Federal University of Health Science of Porto Alegre (other) |
| Locations | 2 sites (Veranópolis, Rio Grande do Sul and 1 other locations) |
| Trial ID | NCT06259968 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of neuromuscular electrical stimulation (NMES) combined with voluntary contraction versus NMES alone during the first month of rehabilitation following anterior cruciate ligament reconstruction (ACLR). Forty patients will be randomly assigned to either the NMES group or the NMES+ group, both following the same rehabilitation regimen aimed at managing symptoms, controlling inflammation, reducing edema, improving joint motion, and restoring muscle function. Assessments will occur at four time points: pre-surgery, and at 2, 15, and 30 days post-surgery, focusing on maximal isometric strength of knee extensors and other secondary outcomes related to muscle atrophy and functional impairments.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 40 scheduled for ACL reconstruction surgery.
Not a fit: Patients who are unable to initiate rehabilitation within 7 days post-surgery or have related injuries that prevent partial weight-bearing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation outcomes for patients recovering from ACL reconstruction.
How similar studies have performed: Previous studies have shown promise in using neuromuscular electrical stimulation for rehabilitation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Veranópolis, Rio Grande do Sul and 1 other locations
- Private Rehabilitation Center — Veranópolis, Rio Grande do Sul, Brazil (NOT_YET_RECRUITING)
- Private Rehabilitation Center — Veranópolis, Rio Grande do Sul, Brazil (RECRUITING)
Study contacts
- Study coordinator: Gabriela Bissani Gasparin
- Email: gabriela.gasparin@hotmail.com
- Phone: +5554991296689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction, Neuromuscular Electrical Stimulation, Knee, Physiotherapy, Quadriceps, Anterior cruciate ligament reconstruction