Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT03036033
Status:
UNKNOWN
Last Update Posted:
2017-01-30
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The SaeboGlove Evaluation Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group, open feasibility study of use of a CE marked and available device.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-07-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-27', 'studyFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2017-01-27', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of sessions performed using the SaeboGlove', 'timeFrame': 'One month', 'description': 'Feasibility'}], 'secondaryOutcomes': [{'measure': 'Therapy Intensity', 'timeFrame': 'Cumulative over one month', 'description': 'Number of movement repetitions performed using the SaeboGlove'}, {'measure': 'Participant, Carer and Therapist Usability and Training Questionnaire', 'timeFrame': 'One month', 'description': 'Bespoke questionnaire'}, {'measure': 'Box and Block Test', 'timeFrame': 'One month', 'description': 'Measure to assess gross dexterity'}, {'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': 'One month', 'description': 'Measure to assess arm function'}, {'measure': 'Motor Activity Log (MAL)', 'timeFrame': 'One month', 'description': 'Interview intended to examine how much and how well the participant uses arm'}, {'measure': 'Number of adverse events related to using the SaeboGlove', 'timeFrame': 'One month', 'description': 'Safety'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Cerebral Vascular Disorder', 'Brain Diseases', 'Central Nervous System Diseases', 'Nervous System Diseases', 'Vascular Diseases', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety, feasibility and usability of a SaeboGlove rehabilitation device in the treatment of patients who have reduced ability to open their hand due to weakness after an acute stroke.', 'detailedDescription': 'The SaeboGlove is a new rehabilitation aid that can be used in people with hand weakness after a neurological injury. It assists the hand to open, which is crucial for people to grasp, and release everyday objects. It may improve function by doing this but may also help people with severe weakness take part more fully in therapy sessions. This glove is already marketed and is being used in some NHS sites. This trial will assess how it could be used in NHS practice in acute stroke patients and will develop a plan to implement this.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to consent\n2. Aged ≥18 years\n3. Diagnosis of stroke occurring ≤30 days ago\n4. Reduced active range of movement wrist and / or finger extension\n5. Modified ashworth score at wrist and fingers ≤ 2\n6. Some initiation of gross active finger flexion\n7. At least 10 degrees passive range of motion wrist extension\n8. Considered able to learn to don / doff a SaeboGlove +/- help of willing carer\n9. Ability to engage in some independent rehabilitation +/- help of willing carer\n10. Considered able to comply with the requirements of protocol?\n\nExclusion Criteria:\n\n1. Presence of \\>5-10 degrees digital contractures\n2. Presence of other upper limb impairment that would influence participation (e.g. fixed contracture, frozen shoulder, severe arthritis or upper limb pain)\n3. Presence of other conditions likely to influence participation (e.g. medically unstable, registered blind, terminal cancer, severe mood, cognitive or language issues)\n4. Participating in another stroke rehabilitation trial'}, 'identificationModule': {'nctId': 'NCT03036033', 'acronym': 'T-SET', 'briefTitle': 'The SaeboGlove Evaluation Trial', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'The SaeboGlove Evaluation Trial in Stroke', 'orgStudyIdInfo': {'id': 'GN16ST162'}, 'secondaryIdInfos': [{'id': 'Res16/A169', 'type': 'OTHER_GRANT', 'domain': 'CHSS'}, {'id': '16/NS/0112', 'type': 'OTHER', 'domain': 'North of Scotland Research Ethics Service'}, {'id': '207595', 'type': 'OTHER', 'domain': 'Integrated Research Application System'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SaeboGlove Therapy', 'description': 'All participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program.', 'interventionNames': ['Device: SaeboGlove']}], 'interventions': [{'name': 'SaeboGlove', 'type': 'DEVICE', 'description': 'All participants are given a Saebo glove to use during their stroke recovery.', 'armGroupLabels': ['SaeboGlove Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G51 4TF', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jen Alexander', 'role': 'CONTACT', 'email': 'jen.alexander@ggc.scot.nhs.uk', 'phone': '0141 451 5870', 'phoneExt': '85870'}, {'name': 'Dr Jesse Dawson', 'role': 'CONTACT', 'email': 'Jesse.Dawson@glasgow.ac.uk', 'phone': '0141 451 5868', 'phoneExt': '85868'}, {'name': 'Elizabeth Colquhoun', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Queen Elizabeth University Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'centralContacts': [{'name': 'Jen Alexander', 'role': 'CONTACT', 'email': 'jen.alexander@ggc.scot.nhs.uk', 'phone': '0141 451 5870', 'phoneExt': '85870'}, {'name': 'Dr Jesse Dawson', 'role': 'CONTACT', 'email': 'Jesse.Dawson@glasgow.ac.uk', 'phone': '0141 451 5868', 'phoneExt': '85868'}], 'overallOfficials': [{'name': 'Dr Jesse Dawson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Glasgow', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Reader', 'investigatorFullName': 'Dr Jesse Dawson', 'investigatorAffiliation': 'NHS Greater Glasgow and Clyde'}}}}