Anterior Cruciate Ligament Reconstruction RehabilitationNCT06259968
Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial
A study testing Neuromuscular electrical stimulation and Neuromuscular electrical stimulation with superimposed voluntary contraction in people with Anterior Cruciate Ligament Reconstruction Rehabilitation and Anterior Cruciate Ligament Reconstruction, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Neuromuscular electrical stimulation and Neuromuscular electrical stimulation with superimposed voluntary contraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Not yet recruiting
Private Rehabilitation Center
Veranópolis, Rio Grande do Sul, 95330000
Gabariela Bissani Gasparin, +5554991296689
Gabriela Bissani Gasparin
- Recruiting
Private Rehabilitation Center
Veranópolis, Rio Grande do Sul, 95330000
Gabariela Bissani Gasparin, 54991296689, gabriela.gasparin@hotmail.com
About this study
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.
- Conditions
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction
- Being tested
- Neuromuscular electrical stimulation, Neuromuscular electrical stimulation with superimposed voluntary contraction
- Keywords
- Neuromuscular Electrical Stimulation, Knee, Physiotherapy, Quadriceps, Anterior cruciate ligament reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
Also called NMES
Patients in the neuromuscular electrical stimulation group will receive neuromuscular electrical stimulation without the concomitant execution of voluntary quadriceps contraction
Neuromuscular electrical stimulation with superimposed voluntary contractionDevice
Also called NMES +
Patients will be instructed to perform maximum voluntary contractions superimposed on neuromuscular electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| NMES+ | Experimental | Neuromuscular electrical stimulation with superimposed voluntary contraction Receives: Device: Neuromuscular electrical stimulation with superimposed voluntary contraction |
| NMES | Active comparator | Neuromuscular electrical stimulation without voluntary contraction Receives: Device: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal isometric strength of knee extensors
Assessed by manual isometric dynamometry
Measured: Before surgery and 30 days post-surgery.
Secondary outcomes (6)
Joint range of motion
Joint range of motion will be assessed using heel-height measurement and goniometry
Measured: Before surgery, and then at 2, 15, and 30 days post-surgery.
Self-reported functional impairments
Self-reported functional impairments will be assessed using Lysholm Scale and the Knee Outcome Survey-Activities of Daily Living Scale (KOS-ADLS)
Measured: Before surgery, and then at 2, 15, and 30 days post-surgery.
Quadriceps activation status
The quadriceps activation status will be assessed by lag sign.
Measured: Before surgery, and then at 2, 15, and 30 days post-surgery.
Muscle atrophy
The evaluation of muscle atrophy will be performed by measuring the circumference of the thigh.
Measured: Before surgery, and then at 2, 15, and 30 days post-surgery.
Knee edema
Joint swelling will be assessed using the Stroke Test.
Measured: Before surgery, and then at 2, 15, and 30 days post-surgery.
Knee pain
The severity of knee pain will be assessed through the numerical pain rating scale.
Measured: Before surgery, and then at 2, 15, and 30 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament Reconstruction RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Manfredini Baroni, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259968
- Sponsor's protocol ID
- 76203223.0.0000.5345
- Status last verified
- Mar 2025
- First submitted
- 23 Jan 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06259968
- Acronym / sponsor ID
- 76203223.0.0000.5345
- Conditions
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction
- Keywords
- Neuromuscular Electrical Stimulation, Knee, Physiotherapy, Quadriceps, Anterior cruciate ligament reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES+ | Experimental | Device: Neuromuscular electrical stimulation with superimposed voluntary contractionNeuromuscular electrical stimulation with superimposed voluntary contraction |
| NMES | Active comparator | Device: Neuromuscular electrical stimulationNeuromuscular electrical stimulation without voluntary contraction |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationAlso: NMESPatients in the neuromuscular electrical stimulation group will receive neuromuscular electrical stimulation without the concomitant execution of voluntary quadriceps contraction | Device | NMES |
| Neuromuscular electrical stimulation with superimposed voluntary contractionAlso: NMES +Patients will be instructed to perform maximum voluntary contractions superimposed on neuromuscular electrical stimulation | Device | NMES+ |
Primary outcome
Maximal isometric strength of knee extensors
Time frame: Before surgery and 30 days post-surgery.
Assessed by manual isometric dynamometry
6 secondary outcomes
Joint range of motion
Time frame: 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.
Quadriceps activation status
Time frame: 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.
Knee edema
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation and Neuromuscular electrical stimulation with superimposed voluntary contraction in people with Anterior Cruciate Ligament Reconstruction Rehabilitation and Anterior Cruciate Ligament Reconstruction, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Bissani Gasparin (+5554991296689, gabriela.gasparin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal isometric strength of knee extensors (time frame: Before surgery and 30 days post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.