Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 7:20 AM
Study NCT ID:
NCT06259968
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2024-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal isometric strength of knee extensors', 'timeFrame': 'Before surgery and 30 days post-surgery.', 'description': 'Assessed by manual isometric dynamometry'}], 'secondaryOutcomes': [{'measure': 'Joint range of motion', 'timeFrame': 'Before surgery, and then at 2, 15, and 30 days post-surgery.', 'description': 'Joint range of motion will be assessed using heel-height measurement and goniometry'}, {'measure': 'Self-reported functional impairments', 'timeFrame': 'Before surgery, and then at 2, 15, and 30 days post-surgery.', 'description': 'Self-reported functional impairments will be assessed using Lysholm Scale and the Knee Outcome Survey-Activities of Daily Living Scale (KOS-ADLS)'}, {'measure': 'Quadriceps activation status', 'timeFrame': 'Before surgery, and then at 2, 15, and 30 days post-surgery.', 'description': 'The quadriceps activation status will be assessed by lag sign.'}, {'measure': 'Muscle atrophy', 'timeFrame': 'Before surgery, and then at 2, 15, and 30 days post-surgery.', 'description': 'The evaluation of muscle atrophy will be performed by measuring the circumference of the thigh.'}, {'measure': 'Knee edema', 'timeFrame': 'Before surgery, and then at 2, 15, and 30 days post-surgery.', 'description': 'Joint swelling will be assessed using the Stroke Test.'}, {'measure': 'Knee pain', 'timeFrame': 'Before surgery, and then at 2, 15, and 30 days post-surgery.', 'description': 'The severity of knee pain will be assessed through the numerical pain rating scale.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuromuscular Electrical Stimulation', 'Knee', 'Physiotherapy', 'Quadriceps', 'Anterior cruciate ligament reconstruction'], 'conditions': ['Anterior Cruciate Ligament Reconstruction Rehabilitation', 'Anterior Cruciate Ligament Reconstruction']}, 'descriptionModule': {'briefSummary': '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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.\n\nExclusion Criteria:\n\n* Failure to attend the pre-surgery assessment session;\n* Delay of more than 7 days after surgery to initiate the rehabilitation program proposed by the study;\n* 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.'}, 'identificationModule': {'nctId': 'NCT06259968', 'briefTitle': 'Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Health Science of Porto Alegre'}, 'officialTitle': 'Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '76203223.0.0000.5345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NMES+', 'description': 'Neuromuscular electrical stimulation with superimposed voluntary contraction', 'interventionNames': ['Device: Neuromuscular electrical stimulation with superimposed voluntary contraction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NMES', 'description': 'Neuromuscular electrical stimulation without voluntary contraction', 'interventionNames': ['Device: Neuromuscular electrical stimulation']}], 'interventions': [{'name': 'Neuromuscular electrical stimulation', 'type': 'DEVICE', 'otherNames': ['NMES'], 'description': 'Patients in the neuromuscular electrical stimulation group will receive neuromuscular electrical stimulation without the concomitant execution of voluntary quadriceps contraction', 'armGroupLabels': ['NMES']}, {'name': 'Neuromuscular electrical stimulation with superimposed voluntary contraction', 'type': 'DEVICE', 'otherNames': ['NMES +'], 'description': 'Patients will be instructed to perform maximum voluntary contractions superimposed on neuromuscular electrical stimulation', 'armGroupLabels': ['NMES+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95330000', 'city': 'Veranópolis', 'state': 'Rio Grande do Sul', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Gabariela Bissani Gasparin', 'role': 'CONTACT', 'phone': '+5554991296689'}, {'name': 'Gabriela Bissani Gasparin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Private Rehabilitation Center', 'geoPoint': {'lat': -28.93611, 'lon': -51.54944}}, {'zip': '95330000', 'city': 'Veranópolis', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Gabariela Bissani Gasparin', 'role': 'CONTACT', 'email': 'gabriela.gasparin@hotmail.com', 'phone': '54991296689'}], 'facility': 'Private Rehabilitation Center', 'geoPoint': {'lat': -28.93611, 'lon': -51.54944}}], 'centralContacts': [{'name': 'Gabriela Bissani Gasparin', 'role': 'CONTACT', 'email': 'gabriela.gasparin@hotmail.com', 'phone': '+5554991296689'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Health Science of Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Bruno Manfredini Baroni', 'investigatorAffiliation': 'Federal University of Health Science of Porto Alegre'}}}}