Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-31 @ 7:37 PM
Study NCT ID:
NCT02924168
Status:
COMPLETED
Last Update Posted:
2018-06-07
First Post:
2016-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radial Shock Waves for Functional Disability in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2016-09-29', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events (AE)', 'timeFrame': 'Weekly for two months', 'description': 'Accountability of occurences of Adverse Events'}], 'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment (FMA)', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'Mean change in Fugl Meyer Assessment score after four sessions of Radial Shockwave Therapy (RSWT) as compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'Baseline, one and two months', 'description': 'Multiple changes in VAS'}, {'measure': 'Esthesiometry - Von Frey Scale', 'timeFrame': 'Baseline, one and two months', 'description': 'Multiple changes in Von Frey Scale'}, {'measure': 'Upper Limb Modified Ashworth Scale (MAS)', 'timeFrame': 'Baseline, one week, two weeks, three weeks, four weeks and two months', 'description': 'Multiple changes in MAS'}, {'measure': 'Fugl-Meyer Assessment', 'timeFrame': 'Baseline and two months', 'description': 'Changes in Fugl-Meyer Assessment compared to baseline'}, {'measure': 'Medical Research Council scale (MRC)', 'timeFrame': 'Baseline, one and two months', 'description': 'Multiple changes in MRC scale'}, {'measure': 'Hand grip', 'timeFrame': 'Baseline, one and two months', 'description': 'Multiple changes in Hand grip'}, {'measure': 'Change in fine motor function measured with Finger Tapping (FT)', 'timeFrame': 'Baseline, one and two months', 'description': 'Multiple changes in FT'}, {'measure': 'Jebsen-Taylor Hand Function Test (JTHFT)', 'timeFrame': 'Baseline, one and two months', 'description': 'Multiple changes in JTHFT'}, {'measure': 'Purdue Pegboard Test (PPBT)', 'timeFrame': 'Baseline, one and two months', 'description': 'Multiple changes in PPBT'}, {'measure': 'Robotic kinematic evaluation (RKE)', 'timeFrame': 'Baseline, one and two months', 'description': 'Multiple changes in RKE'}, {'measure': 'Corticospinal excitability measures with transcranial magnetic stimulation (TMS)', 'timeFrame': 'Baseline, one and two months', 'description': 'Multiple changes in Corticospinal excitability'}, {'measure': 'Pinch strength testing', 'timeFrame': 'Baseline, one and two months', 'description': 'Pinch strength testing'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'This is a double blind randomized clinical trial to evaluate the effect of radial shock waves on functional recovery of the upper limb of patients with sequelae of ischemic strokes in the territory of the middle cerebral artery. A total of 20 patients will be enrolled and will undergo motor, functional and cortical excitability evaluations before and after four weekly sessions of radial shockwaves. 5,000 pulses with a frequency of 15 Hz and 3.5 to 4 bar of air pressure will be applied to the active group, resulting in an energy flux density (EFD) of approximately 0.07 mJ/mm2. The sham group will receive identical treatment, except for the fact that no energy flux will be applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and radiological diagnosis: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan indicating Stroke in the territory of the middle cerebral artery;\n* 6 to 24 months after stroke date;\n* Stability observed in clinical medical evaluation\n* Granting of written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Individuals with a score lower than 24 on the Mini-mental test;\n* Previously documented strokes\n* Pregnancy\n* Patients treated with botulinum toxin, phenol, alcohol or previous surgeries six months before entering the study\n* Bone diseases, pre-existing joint damage, and deformities affecting the patient in a way to interfere with implementation of the proposed therapy\n* Psycho-affective disorder that prevents adherence\n* Joint pain that occurs within the movement range of therapies'}, 'identificationModule': {'nctId': 'NCT02924168', 'briefTitle': 'Radial Shock Waves for Functional Disability in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effect of Radial Shock Waves for the Treatment of Upper Limb Functional Disability in Stroke Sequelae', 'orgStudyIdInfo': {'id': '19109813.1.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Radial Shockwave', 'description': 'Every patient will receive 5,000 continuous pulses per treatment session, at 3.5 to 4 bar air pressure (resulting in an energy flux density \\[EFD\\] of approximately 0.07 mJ/mm2) and at 15Hz frequency. A total of 4 sessions will be performed.', 'interventionNames': ['Device: Active Radial Shockwave']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Radial Shockwave', 'description': 'Every patient will receive 5,000 continuous pulses per treatment session, without air pressure (resulting in no EFD) and at 15Hz frequency. A total of 4 sessions will be performed.', 'interventionNames': ['Device: Sham Radial Shockwave']}], 'interventions': [{'name': 'Active Radial Shockwave', 'type': 'DEVICE', 'description': 'Four weekly sessions of active radial shockwave treatment.', 'armGroupLabels': ['Active Radial Shockwave']}, {'name': 'Sham Radial Shockwave', 'type': 'DEVICE', 'description': 'Four weekly sessions of sham radial shockwave treatment.', 'armGroupLabels': ['Sham Radial Shockwave']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04116-030', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Medicina Fisica e Reabilitacao HCFMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Marta Imamura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Medicina Física e Reabilitação HCFMUSP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marta Imamura', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Marta Imamura', 'investigatorAffiliation': 'University of Sao Paulo'}}}}