Clinical trial NCT06259968: Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial
Official title: Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation
Anterior Cruciate Ligament Reconstruction
Keywords: Neuromuscular Electrical Stimulation
Knee
Physiotherapy
Quadriceps
Anterior cruciate ligament reconstruction
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Maximal isometric strength of knee extensors
timeFrame: Before surgery and 30 days post-surgery.
Secondary outcomes:
measure: Joint range of motion
timeFrame: Before surgery, and then at 2, 15, and 30 days post-surgery.
measure: Self-reported functional impairments
timeFrame: Before surgery, and then at 2, 15, and 30 days post-surgery.
measure: Quadriceps activation status
timeFrame: Before surgery, and then at 2, 15, and 30 days post-surgery.
measure: Muscle atrophy
timeFrame: Before surgery, and then at 2, 15, and 30 days post-surgery.
measure: Knee edema
timeFrame: Before surgery, and then at 2, 15, and 30 days post-surgery.
measure: Knee pain
timeFrame: Before surgery, and then at 2, 15, and 30 days post-surgery.
Other outcomes:
Locations:
city: Veranópolis
country: Brazil
facility: Private Rehabilitation Center
state: RS
city: Veranópolis
country: Brazil
facility: Private Rehabilitation Center
state: RS
Study officials:
References: