Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 9:40 PM
Study NCT ID:
NCT01139034
Status:
UNKNOWN
Last Update Posted:
2010-06-22
First Post:
2010-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of Shoulder Subluxation Treatment by Using the Self-Designed Surface Functional Electrical Stimulator
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-20', 'studyFirstSubmitDate': '2010-06-07', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upward migration index', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Acromiohumeral distance', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of the self-designed surface functional electrical stimulator on shoulder joint subluxation for stroke patients', 'detailedDescription': 'Functional electrical stimulation (FES) is a common and effective therapeutic approach for clinical treatments of shoulder subluxation. By applying low-frequency electrical stimulation to the target muscle groups, improvements may be observed in terms of muscle strength, subluxation, and passive humeral lateral rotation of the shoulder joint. In order to overcome issues regarding the integration of an FES and a rehabilitation robot, group members have designed a customized FES system approved by medical safety regulations. Despite sharing identical specifications with commercial models, the approved 2-channel FES system provides better integrity and control when working with the upper extremity rehabilitation robot. In this study, three patients with unilateral shoulder subluxation will be recruited. Limited shoulder x-ray photos shall be taken before, during, and after the FES shoulder subluxation treatment for studying the effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stroke (1-3 months)\n* Brunnstrom Stage I-III\n* single, unilateral\n\nExclusion Criteria:\n\n* aphasic\n* shoulder impairment\n* severe osteoporosis\n* cardiac arrhythmias or having a pacemaker implanted\n* abnormal cutaneous sensation at the target areas'}, 'identificationModule': {'nctId': 'NCT01139034', 'briefTitle': 'A Pilot Study of Shoulder Subluxation Treatment by Using the Self-Designed Surface Functional Electrical Stimulator', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Rehabilitation Robot for Upper Limbs, Component Project 2: Hybrid of FES and Rehabilitation Robot for Treatment of Shoulder Subluxation', 'orgStudyIdInfo': {'id': '201002029D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'shoulder FES treatment', 'interventionNames': ['Device: Self-designed surface functional electrical stimulator']}], 'interventions': [{'name': 'Self-designed surface functional electrical stimulator', 'type': 'DEVICE', 'otherNames': ['Self-designed surface functional electrical stimulation'], 'description': 'Use the self-designed surface functional electrical stimulator to improve the shoulder joint subluxation.', 'armGroupLabels': ['shoulder FES treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jin-Shin Lai', 'role': 'CONTACT', 'email': 'jslai@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '66583'}, {'name': 'Jin-Shin Lai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Physical Medicine and Rehabilitation, NTUH', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jin-Shin Lai', 'role': 'CONTACT', 'email': 'jslai@ntu.edu.tw', 'phone': '+886-2-23123456', 'phoneExt': '66583'}], 'overallOfficials': [{'name': 'Jin-Shin Lai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physical Medicine and Rehabilitation, NTUH, Taipei, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jin-Shin Lai', 'oldOrganization': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital'}}}}