Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT01945151
Status:
UNKNOWN
Last Update Posted:
2013-09-18
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of the Electrical Muscle Activity and Resistance to Movement in Spastic Hemiparetic Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-13', 'studyFirstSubmitDate': '2013-06-27', 'studyFirstSubmitQcDate': '2013-09-13', 'lastUpdatePostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of the electrical muscle activity and resistance to movement after application of neuromuscular electrical stimulation (NMES) in patients with spastic hemiparesis.', 'timeFrame': '12 months', 'description': 'The G1 apply Neuromuscular Electrical Stimulation on the motor point of the tibialis anterior and triceps surae lengthening held along with the contraction (reciprocal inhibition). The G2 apply electrical muscle activity and resistance to movement after application of neuromuscular electrical stimulation (NMES) in patients with spastic hemiparesis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spastic hemiparesis'], 'conditions': ['Cerebrovascular Accident']}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the effects of Neuromuscular Electrical Stimulation when applied in the agonist and antagonist muscles of spastic hemiparetic patients.\n\nThe specific objectives are:\n\n* Evaluate the resistance movement, strength and muscle electrical activity before and after application of Neuromuscular Electrical Stimulation in spastic muscle (gastrocnemius).\n* Evaluate the resistance movement, strength and muscle electrical activity before and after application of Neuromuscular Electrical Stimulation in the spastic antagonist muscle (tibialis anterior).\n* Compare the risk of falls after application of Neuromuscular Electrical Stimulation in both muscles studied.', 'detailedDescription': 'Most hemiparetic patients can develop spasticity, characterized by neuronal hyperexcitability, increased resistance to passive stretch, Babinski sign, clonus, reflexes and involuntary spasms skin.\n\nAs a consequence, there may be contractures and muscle shortening, generating functional limitations. Neuromuscular Electrical Stimulation feature that can control the spasticity through reciprocal inhibition, muscle relaxation and sensory stimulation. The goal will be to evaluate and compare the effects of neuromuscular electrical stimulation when applied in the agonist and antagonist muscles of spastic hemiparetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* involve patients who have spasticity grade 1, 1 + and 2 of the gastrocnemius muscle, which ambulate with or without assistance devices, patients who tolerate the stimulus and have preserved cognition.\n\nExclusion Criteria:\n\n* involve patients who have severe shortening, joint stiffness, cognitive deficits and patients with hypersensitivity.'}, 'identificationModule': {'nctId': 'NCT01945151', 'acronym': 'EENM', 'briefTitle': 'Analysis of the Electrical Muscle Activity and Resistance to Movement in Spastic Hemiparetic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Vale do Paraíba'}, 'officialTitle': 'Analysis of the Electrical Muscle Activity and Resistance to Movement After Pplication Neuromuscular Electrical Stimulation (EENM) in Patients With Hemiparesis Spastic.', 'orgStudyIdInfo': {'id': '03559712.6.0000.0077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (G1) NMES is applied in the spastic antagonist muscle', 'description': 'The parameters considered for the application of NMES are: frequency of 50Hz, the wavelength of 350m / s, 10 seconds of contraction of 20 seconds of rest to total 15 minutes. During the application of NMES patients will be positioned supine on the bed with knees flexed semi supported on roller positioning. The G1 apply NMES on the motor point of the tibialis anterior and triceps surae lengthening held along with the contraction (reciprocal inhibition).', 'interventionNames': ['Other: Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius).']}], 'interventions': [{'name': 'Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius).', 'type': 'OTHER', 'description': 'The G2 apply NMES in the gastrocnemius motor point and the rest will be done during stretching of the gastrocnemius muscle (autogenic inhibition). Five consecutive sessions will be held in the morning and afternoon in the laboratory of Sensory Motor Rehabilitation Engineering.', 'armGroupLabels': ['Group 1 (G1) NMES is applied in the spastic antagonist muscle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55', 'city': 'São José dos Campos', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Sergio ST Takeshi, pesquisadora', 'role': 'CONTACT', 'email': 's.takeshi@hotmail.com', 'phone': '55 12 8137-1012', 'phoneExt': '2066'}], 'facility': 'Laboratório de Engenharia de Reabilitação Sensorio Motora', 'geoPoint': {'lat': -23.17944, 'lon': -45.88694}}], 'centralContacts': [{'name': 'Sergio ST Takeshi, pesquisadora', 'role': 'CONTACT', 'email': 's.takeshi@hotmail.com', 'phone': '55 12 39947 1000', 'phoneExt': '2066'}], 'overallOfficials': [{'name': 'Sergio ST Takeshi, pesquisador', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade do Vale do Paraíba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Vale do Paraíba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}