Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-02 @ 11:42 AM
Study NCT ID:
NCT04163666
Status:
UNKNOWN
Last Update Posted:
2022-06-27
First Post:
2019-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mirror Therapy and Cognitive Therapeutic Exercise in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088762', 'term': 'Mirror Movement Therapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-24', 'studyFirstSubmitDate': '2019-11-06', 'studyFirstSubmitQcDate': '2019-11-13', 'lastUpdatePostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functionality of the affected upper member.', 'timeFrame': '3 months', 'description': 'Measurement by Fugl-Meyer Scale: Score between 0 (worst functionality) and 126 (best functionality)'}], 'secondaryOutcomes': [{'measure': 'Spasticity of the upper member', 'timeFrame': '3 months', 'description': 'Measurement by Ashworth Scale: Score between 0 (best situation) and 5 (worst situation)'}, {'measure': 'Cognitive performance.', 'timeFrame': '3 months', 'description': 'Measurement by Montreal Cognitive Assessment Scale: Score between 0 (worst cognitive situation ) and 30 (best cognitive situation)'}, {'measure': 'Emotional state and quality of life.', 'timeFrame': '3 months', 'description': 'Measurement by Post-Stroke Quality of Life Scale: Score between 30 (best state) and 155 (worst state)'}, {'measure': 'Basic Daily Living Activities', 'timeFrame': '3 months', 'description': 'Measurement by Functional Independence Measure - Functional Assessment Measure: Score between 30 (worst situation) and 210 (best situation)'}, {'measure': 'Instrumental activities of daily living', 'timeFrame': '3 months', 'description': 'Measurement by Lawton-Brody Index: Score between 0 (worst state) and 6 (best state)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Upper member', 'Neurorehabilitation', 'Mirror therapy', 'Therapeutic cognitive exercise', 'Perfetti'], 'conditions': ['Stroke', 'Hemiparesis']}, 'referencesModule': {'references': [{'pmid': '32978182', 'type': 'DERIVED', 'citation': 'Gonzalez-Santos J, Soto-Camara R, Rodriguez-Fernandez P, Jimenez-Barrios M, Gonzalez-Bernal J, Collazo-Riobo C, Jahouh M, Bravo-Anguiano Y, Trejo-Gabriel-Galan JM. Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial. BMJ Open. 2020 Sep 25;10(9):e035768. doi: 10.1136/bmjopen-2019-035768.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized clinical trial aimed at patients with a diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke. Its objective is to evaluate the effects of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, to achieve maximum functionality of the affected upper member,', 'detailedDescription': 'Objective: To assess the effect at 3 months of the of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, applied for 30 days in the functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and quality of life in stroke patients.\n\nDesign and setting: A randomized clinical trial of three parallel groups.\n\nPopulation: 152 patients with residual hemiparesis due to ischemic or hemorrhagic stroke will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the University Hospital of Burgos (HUBU).\n\nMeasurements and intervention: Functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and health-related quality of life will be evaluated. The intervention groups will receive a treatment based either on mirror therapy or on congnitive therapeutic exercise, both combined with task-oriented motor learning for 30 days. No additional intervention with the participants of the control group will be completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke,\n* Movements of the affected upper members classified between stages II and IV on the Brunnstrom Scale\n* Score on the Montreal Cognitive Assessment (MOCA) scale equal to or over 26\n\nExclusion Criteria:\n\n* Heminegligence\n* Wernicke's aphasia\n* Visual deficits (homonymous hemianopsia)"}, 'identificationModule': {'nctId': 'NCT04163666', 'briefTitle': 'Effects of Mirror Therapy and Cognitive Therapeutic Exercise in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Burgos'}, 'officialTitle': 'Effects of Mirror Therapy and Cognitive Therapeutic Exercise on Improvements to the Upper Member Functions of Stroke Patients: a Randomized Clinical Test Study Protocol', 'orgStudyIdInfo': {'id': 'UBU-HUBU: MT-CTE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirror therapy group', 'description': 'The mirror therapy group will receive a treatment based on this therapy, combined with task-oriented motor learning.', 'interventionNames': ['Behavioral: Mirror therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive therapeutic exercise group', 'description': 'The cognitive therapeutic exercise group will receive a treatment based on this therapy, combined with task-oriented motor learning.', 'interventionNames': ['Behavioral: Cognitive therapeutic exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No additional intervention with the participants of this group will be completed.'}], 'interventions': [{'name': 'Mirror therapy', 'type': 'BEHAVIORAL', 'description': 'The intervention will take place at the home of the participant for 6 weeks (30 days), during 60-minute sessions, 30 of which will be for mirror therapy, while the remaining 30 minutes will be for task-oriented motor learning', 'armGroupLabels': ['Mirror therapy group']}, {'name': 'Cognitive therapeutic exercise', 'type': 'BEHAVIORAL', 'description': 'The intervention will take place at the home of the participant for 6 weeks (30 days), during 60-minute sessions, 30 of which will be for cognoscitive therapeutic exercise, while the remaining 30 minutes will be for task-oriented motor learning', 'armGroupLabels': ['Cognitive therapeutic exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09006', 'city': 'Burgos', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raul Soto-Cámara, PhD', 'role': 'CONTACT', 'email': 'rscamara@ubu.es', 'phone': '+34 673192039'}, {'name': 'Jeronimo Gonzalez-Bernal, PhD', 'role': 'CONTACT', 'email': 'jejavier@ubu.es', 'phone': '+34 947499108'}], 'facility': 'Universitary Hospital of Burgos', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}], 'centralContacts': [{'name': 'Raul Soto-Camara, PhD', 'role': 'CONTACT', 'email': 'rscamara@ubu.es', 'phone': '+34 673192039'}, {'name': 'Jeronimo Gonzalez-Bernal, PhD', 'role': 'CONTACT', 'email': 'jejavier@ubu.es', 'phone': '+34 947499108'}], 'overallOfficials': [{'name': 'Raul Soto-Camara, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Burgos University'}, {'name': 'Jeronimo Gonzalez-Bernal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Burgos University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Burgos', 'class': 'OTHER'}, 'collaborators': [{'name': 'Castilla-León Health Service', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}