Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT05112094
Status:
UNKNOWN
Last Update Posted:
2021-11-08
First Post:
2021-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Magnetic Stimulation to Treat Patient With Post-stroke Shoulder-hand Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012019', 'term': 'Reflex Sympathetic Dystrophy'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '2021-10-03', 'studyFirstSubmitQcDate': '2021-10-27', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '0,7, 14,28 days', 'description': 'change of 10-point Visual Analog Scale (0-10, higher scores mean a worse outcome)'}], 'secondaryOutcomes': [{'measure': 'strength of upper limb', 'timeFrame': '0,7, 14,28 days', 'description': 'change of score of Manual muscle testing (0-5, higher scores mean a better outcome)'}, {'measure': 'spasticity of upper limb', 'timeFrame': '0,7, 14,28 days', 'description': 'change of Modified Ashworth Scale (0-4, higher scores mean a worse outcome)'}, {'measure': 'range of motion of shoulder', 'timeFrame': '0,7, 14,28 days', 'description': 'Change in range of motion in degree in flexion, extension, abduction, external and internal rotation (0-180 degrees,higher scores mean a better outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shoulder pain', 'magnetic stimulation', 'electric stimulation', 'reflex sympathetic dystrophy'], 'conditions': ['Reflex Sympathetic Dystrophy of Upper Limb', 'Stroke']}, 'descriptionModule': {'briefSummary': "Shoulder-hand syndrome is a common complication following stroke, constituting of excessive pain, swelling, heat, limited range of motion, and trophic change of the affected limbs. It not only has an extensive negative impact on both physical and psychological aspects of a stroke patient's well-being, but also impose burden on the health care system and the patient's family. Despite its relatively high incidence, there is neither well-established treatment protocol, nor high quality evidence for a single effective treatment. The objective of the present study is to investigate the efficacy, including pain, spasticity, and subluxation reduction, muscle strengthening, and shoulder range of motion improvement, of high-intensity peripheral magnetic stimulation generated by the super-inductive system to treat patients with post-stroke shoulder-hand syndrome.", 'detailedDescription': 'The present study aims to investigate the therapeutic effects achieved by the peripheral magnetic stimulation for treating post-stroke shoulder-hand syndrome. The investigators plan to use high-intensity peripheral magnetic stimulation generated by the super-inductive system for treatment of post-stroke shoulder-hand syndrome. In terms of study design, the treatment group will receive 10 sessions of high-intensity peripheral magnetic stimulation 5 days a week for 2 weeks, with physical and occupational therapy kept as usual; while the control group will only receive conventional physical and occupational therapy. Comprehensive assessment, including history taking and physical examination testing for muscle strength, spasticity, shoulder range of motion, before and after the intervention will be conducted for evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* \\>=20 years old\n* Stroke in recent 6 months\n* Clear consciousness\n* Clinical diagnosis of post-stroke shoulder-hand syndrome\n\nExclusion criteria:\n\n* Acute bursitis, tendonitis or tendon tear\n* Fracture, dislocation or joint infection within 3 months\n* Malignancy at treatment site\n* Seizure\n* Prosthesis or implant at treatment site\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05112094', 'briefTitle': 'Peripheral Magnetic Stimulation to Treat Patient With Post-stroke Shoulder-hand Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Therapeutic Effect of Peripheral Magnetic Stimulation Generated by the Super-inductive System to Treat Patient With Post-stroke Shoulder-hand Syndrome', 'orgStudyIdInfo': {'id': '202105016RIPB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'peripheral magnetic stimulation', 'description': 'peripheral magnetic stimulation (50-80% output, 20-40Hz, pulse duration 3-5 seconds, for 15 minutes) + physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day)', 'interventionNames': ['Device: peripheral magnetic stimulation', 'Other: physical therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'physical therapy only', 'description': 'regular physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day)', 'interventionNames': ['Other: physical therapy']}], 'interventions': [{'name': 'peripheral magnetic stimulation', 'type': 'DEVICE', 'description': 'peripheral magnetic stimulation at ipsilateral shoulder ((50-80% output, 20-40Hz, pulse duration 3-5 seconds, for 15 minutes) ) + regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)', 'armGroupLabels': ['peripheral magnetic stimulation']}, {'name': 'physical therapy', 'type': 'OTHER', 'description': 'regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)', 'armGroupLabels': ['peripheral magnetic stimulation', 'physical therapy only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsiao Ming Yen, MDPHD', 'role': 'CONTACT', 'email': 'myferrant@gmail.com', 'phone': '0972652857'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ming Yen Hsiao', 'role': 'CONTACT', 'email': 'myferrant@gmail.com', 'phone': '0972652857'}], 'overallOfficials': [{'name': 'Ming Yen Y Hsiao, MDPHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}