Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-03 @ 6:03 PM
Study NCT ID:
NCT07233161
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients. (m-CIMT, Modified Constraint-induced Movement Therapy)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised, single-centre, single-blind, prospective, prospective clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer', 'timeFrame': 'Basal, immediately after the intervention, 3 months after treatment', 'description': 'The Fugl-Meyer Upper Extremity Scale assesses motor function of the arm and hand after stroke. It measures movements, reflexes and coordination, with a maximum score of 66. It is a structure-measuring tool. This scale is scored from 0 to 66 with 66 being the best score.'}, {'measure': 'Abilhand', 'timeFrame': 'Basal, immediately after the intervention, 3 months after treatment', 'description': "The ABILHAND assesses a person's ability to perform manual activities of daily living. It is based on the patient's perception of the difficulty of these tasks. It is a tool for measuring activity. This scale is scored from 0 to 46 with 46 being the best score."}, {'measure': 'Motor Activity Log', 'timeFrame': '3 months after treatment', 'description': 'The Motor Activity Log (MAL) assesses how much and how well a person uses their affected arm in everyday activities after a stroke. It is based on interviews and rates the Amount of Use and Quality of Movement of the use of the paretic arm in daily life. This scale has two scores, quality and quantity. From 0 to 150 for quantity and from 0 to 150 for quality. 150 being the best result in both cases.'}, {'measure': 'Fatigue Assessment Scale (FAS)', 'timeFrame': 'Basal, immediately after the intervention, 3 months after treatment', 'description': 'The Fatigue Assessment Scale (FAS) is a questionnaire that assesses the level of physical and mental fatigue in patients with various health conditions. It consists of 10 items that the patient answers according to their recent experience.\n\nThis scale has two scores: Mental fatigue from 0 to 25 (sum of items 3, 6, 7, 8 and 9) and physical fatigue from 0 to 25 (sum of items 1, 2, 4, 5 and 10). With 25 being the worst score for both cases.'}, {'measure': 'Stroke Impact Scale', 'timeFrame': 'Basal,immediately after the intervention, 3 months after treatment', 'description': 'The Stroke Impact Scale (SIS) assesses the difficulty a person has in performing daily activities during the last two weeks after a stroke. The minimum score on this scale is 16 points and the maximum is 80 points, with 80 being the best score.'}], 'secondaryOutcomes': [{'measure': 'Modified Rankin Scale (MRS)', 'timeFrame': 'Basal, immediately after the intervention, 3 months after treatment', 'description': 'The modified Rankin Scale (MRS) assesses the degree of disability or dependence in daily activities after a stroke. It ranges from 0 (no symptoms) to 6 (death). The minimum score is 0 and the maximum score is 5 points. The worst score is 5 points.'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': 'Basal, immediately after the intervention, 3 months after treatment', 'description': 'The NIHSS (National Institutes of Health Stroke Scale) is a clinical scale that assesses the severity of stroke. It measures functions such as level of consciousness, language, vision, vision, strength, sensation and coordination. This scale is scored from 0 to 42 with 42 being the worst score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['m-CIMT', 'stroke', 'upper limb weakness', 'upper limb'], 'conditions': ['Isquemic Stroke', 'Upper Limb Weakness Due to Central Neurologic Injury']}, 'referencesModule': {'references': [{'pmid': '25772900', 'type': 'BACKGROUND', 'citation': 'Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. Lancet Neurol. 2015 Feb;14(2):224-34. doi: 10.1016/S1474-4422(14)70160-7.'}, {'pmid': '25398726', 'type': 'BACKGROUND', 'citation': 'Thrane G, Askim T, Stock R, Indredavik B, Gjone R, Erichsen A, Anke A. Efficacy of Constraint-Induced Movement Therapy in Early Stroke Rehabilitation: A Randomized Controlled Multisite Trial. Neurorehabil Neural Repair. 2015 Jul;29(6):517-25. doi: 10.1177/1545968314558599. Epub 2014 Nov 14.'}, {'pmid': '28050492', 'type': 'BACKGROUND', 'citation': 'Yadav RK, Sharma R, Borah D, Kothari SY. Efficacy of Modified Constraint Induced Movement Therapy in the Treatment of Hemiparetic Upper Limb in Stroke Patients: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Nov;10(11):YC01-YC05. doi: 10.7860/JCDR/2016/23468.8899. Epub 2016 Nov 1.'}, {'pmid': '26446577', 'type': 'BACKGROUND', 'citation': 'Corbetta D, Sirtori V, Castellini G, Moja L, Gatti R. Constraint-induced movement therapy for upper extremities in people with stroke. Cochrane Database Syst Rev. 2015 Oct 8;2015(10):CD004433. doi: 10.1002/14651858.CD004433.pub3.'}, {'pmid': '23956560', 'type': 'BACKGROUND', 'citation': 'Singh P, Pradhan B. Study to assess the effectiveness of modified constraint-induced movement therapy in stroke subjects: A randomized controlled trial. Ann Indian Acad Neurol. 2013 Apr;16(2):180-4. doi: 10.4103/0972-2327.112461.'}]}, 'descriptionModule': {'briefSummary': 'm-CIMT therapy is the restriction of the unaffected upper extremity in conjunction with an upper extremity specific exercise protocol to improve the functionality and use of the affected upper extremity.', 'detailedDescription': 'The study consists of a total of 7 days with a total of 3 hours per day of restraint of the unaffected upper limb together with 1 physiotherapy session per day specific to the affected upper limb.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischaemic stroke.\n* Hospitalised patient (first 15 days).\n* Ability to understand and execute simple instructions.\n* Over 18 years of age.\n* Upper limb motor deficit.\n* Sign the informed consent document.\n\nExclusion Criteria:\n\n* Unstable clinical/medical condition.\n* Limitation of the upper limb due to a previous stroke.\n* Strokes affecting both upper limbs bilaterally.\n* Fractures/dislocations in the joints of the affected upper limb that may affect recovery.\n* Severe behavioural disturbance.'}, 'identificationModule': {'nctId': 'NCT07233161', 'acronym': 'm-CIMT', 'briefTitle': 'Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients. (m-CIMT, Modified Constraint-induced Movement Therapy)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients.', 'orgStudyIdInfo': {'id': 'HCB/2024/1353'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'm-CIMT therapy', 'interventionNames': ['Behavioral: m-CIMT']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Conventional treatment'}], 'interventions': [{'name': 'm-CIMT', 'type': 'BEHAVIORAL', 'otherNames': ['m-CIMT protocol'], 'description': 'm-CIMT therapy (healthy side restraint) and a specific upper limb exercise protocol.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria S Suarez, Fisioterapia', 'role': 'CONTACT', 'email': 'suarezi@clinic.cat', 'phone': '+34689409432'}], 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Maria S Suarez, Fisioterapia', 'role': 'CONTACT', 'email': 'suarezi@clinic.cat', 'phone': '+34689409432'}, {'name': 'Ines G Garcia, Fisioterapia', 'role': 'CONTACT', 'phone': '+34665538737'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "We don't have the url with the information"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}