Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-01-14 @ 5:06 AM
Study NCT ID:
NCT02776306
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2016-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mirror Box Imaging Study
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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2016-05-16', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in brain connectivity will be assessed by resting-state fMRI', 'timeFrame': 'Baseline, 3 weeks and at 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Activity of daily living will be assessed with Barthel index.', 'timeFrame': 'Baseline, 3 weeks and at 6 weeks'}, {'measure': 'Function of the affected hemiplegic upper limb will be assessed with action research arm test', 'timeFrame': 'Baseline, 3 weeks and at 6 weeks'}, {'measure': 'Impairment in the hemiplegic upper limb will be assessed with Fugl Meyer test.', 'timeFrame': 'Baseline, 3 weeks and at 6 weeks'}, {'measure': 'Grip strength will be assessed using hand dynamometer', 'timeFrame': 'Baseline, 3 weeks and at 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of mirror box therapy on upper extremity, motor recovery and motor functioning in patients that have suffered a stroke.', 'detailedDescription': 'Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors, with 30%-60% of patients being unable to fully recover functional use of their upper limbs. As recovery may be due to insufficient or inadequate therapeutic interventions, the progress and evaluation of upper limb treatment is currently being investigated.\n\nMirror Box therapy is a task orientated, non-invasive, economic and patient directed therapy for hemiparetic upper limb post stroke patients. The study is intended to evaluate cerebral reorganization by using mirror therapy. Movements of the stronger limb trick the brain into thinking that the weaker arm is moving and to stimulate the respective brain areas.\n\nPatients are enrolled into two groups using standard upper limb rehabilitation for three weeks followed by standard rehabilitation plus Mirror Box for another three weeks (Group 1). Group 2 will receive the same therapy in inverted order.\n\nPatients will receive clinical and functional assessment at baseline, three weeks and six weeks including brain MRI using functional resting state MRI.\n\nThe primary outcome is functional connectivity (correlation coefficient) at baseline and after treatment. Secondary endpoints include motor and functional recovery using outcome measures like Fugl Meyer assessment, Action Research Arm Test, grip and pincer strength. Further secondary endpoints are increase in sensorimotor cortex activation across the period of therapy and cortical reorganization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18yrs to 105yrs\n* Hemiparetic upper limb post stroke\n* Capable of providing informed consent\n* Intact vision: if diagnosis of peripheral field defect, patient should be able to compensate for it.\n\nExclusion Criteria:\n\n* Any contraindication to MRI scanning\n* Clinically significant psychiatric disorder (e.g. depression)\n* Pre-existing neurological or psychiatric disease that could confound the study results.'}, 'identificationModule': {'nctId': 'NCT02776306', 'briefTitle': 'Mirror Box Imaging Study', 'organization': {'class': 'OTHER', 'fullName': 'Mid and South Essex NHS Foundation Trust'}, 'officialTitle': 'Effects of Mirror Box Therapy on Neuroplasticity and Functional Outcome in Hemiparetic Upper Limb Post Stroke', 'orgStudyIdInfo': {'id': 'P0868'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirror box therapy', 'description': 'The participants in the mirror box therapy arm will receive mirror box therapy for 3 weeks for upper limb rehabilitation post stroke.', 'interventionNames': ['Other: Mirror Box therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard treatment group', 'description': 'The participants will receive the standard treatment arm for 3 weeks for upper limb rehabilitation post stroke.'}], 'interventions': [{'name': 'Mirror Box therapy', 'type': 'OTHER', 'description': 'In mirror box therapy the patient uses the reflection of their good arm to trick to brain into thinking that the effected arm is working.', 'armGroupLabels': ['Mirror box therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS0 0RY', 'city': 'Westcliff-on-Sea', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Southend Hospital', 'geoPoint': {'lat': 51.54424, 'lon': 0.69179}}], 'overallOfficials': [{'name': 'Iris Grunwald', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anglia Ruskin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mid and South Essex NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Anglia Ruskin University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}