Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT05300659
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A STudy of Upper Arm Rehabilitation in Stroke Survivors- ASTAR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001134', 'term': 'Arm Injuries'}], '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'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Blinded research nurse will take upper limb measurements at baseline, after 10 therapy sessions and at 6 months follow up, without knowing which of the two groups participant had been randomized to .'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-07-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants retained in this feasibility study.', 'timeFrame': '6 months', 'description': 'Investigators hypothesize that an ARNI approach to upper limb therapy following stroke will be feasible to implement in a standard NHS rehabilitation unit resulting in better upper limb recovery through providing more intensity and enhancing self-management. If the study proves to be feasible - retention of at least 30/36 patients and at least 70% of data relating to exercise intensity, it can be rolled out to several rehabilitation units across the UK. A follow-up multi-centre randomized controlled trial of ARNI-led upper limb therapy plus usual care compared to usual care will then be carried out to provide clinical and cost effectiveness of the ARNI approach. Upper limb function outcomes: Fugl-Meyer test, Action Research Arm Test. Some questionnaires will be used to assess the psychological well-being of patients and carers: Stroke self-efficacy questionnaire, Stroke carer burden scale (CBS), Stroke specific QOL scale, Stroke Impact Scale (SIS) and EQ-5D.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Upper Limb Injury', 'Rehabilitation']}, 'descriptionModule': {'briefSummary': 'This feasibility study will explore the clinical effectiveness of additional upper limb therapy compared to standard care delivered to Stroke Survivors at Sussex Rehabilitation Centre (SRC). Randomization via sealed envelope will allocate treatment group to either routine care or upper limb training for self-management plus routine care. If randomized to upper limb training, a patient will undertake 10 therapy sessions with an instructor from the Action for Rehabilitation for Neurological Injury (ARNI) program during their hospital stay. The last two ARNI-led sessions will be filmed by a nurse/carer on either their own tablet/phone or an i-pad. Participants in the ARNI group will be encouraged to continue doing their personalized exercises while in hospital and continued at home. The participants in the ARNI group will also be given a task-training board to take home.\n\nThis randomized controlled trial will measure outcomes of each group over six months. Each patient in the study will have upper limb physical measurements taken by a blinded Research Nurse (RN2) at baseline. Research Nurse (RN1) will gather data in a Clinical Report File from a weekly exercise diary completed by the patient or carer and well-being questionnaires. On discharge, RN2 will conduct upper limb measurements, collect completed hospital diaries and issue new ones to take4 home. RN1 will give a weekly phone call or text reminders so that patients to complete exercise diaries at home. At 6 months RN2 will do final measurements and complete patient questionnaires in an out patients clinic visit.\n\nThe investigators aim to recruit 36 patients and anticipate 30(8.3%) will complete the 6 month follow-up.\n\nThe study sponsor will be the University of Sussex. However, as the study is run in rehabilitation unit in an NHS hospital, University Hospitals Sussex NHS Trust will host the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke Survivors admitted to Sussex Rehabilitation Centre\n* Aged 18 years or over\n* Have an upper limb affected by stroke\n* Have capacity to consent to participate in the study\n* Medically stable\n\nExclusion Criteria:\n\n* Aged under 18 years\n* AMTS \\<8\n* Have a neurological deficit which does not involve upper limb\n* Presence of a terminal illness with shortened life expectancy \\<6 months.'}, 'identificationModule': {'nctId': 'NCT05300659', 'acronym': 'ASTAR', 'briefTitle': 'A STudy of Upper Arm Rehabilitation in Stroke Survivors- ASTAR', 'organization': {'class': 'OTHER', 'fullName': 'Brighton & Sussex Medical School'}, 'officialTitle': 'Feasibility of an Upper Limb Functional Training Programme to Support Self-management in Stroke Survivors (ASTAR)', 'orgStudyIdInfo': {'id': 'IRAS-254799'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Care'}, {'type': 'EXPERIMENTAL', 'label': 'ARNI care', 'interventionNames': ['Other: Action for Rehabilitation for Neurological Injury (ARNI)']}], 'interventions': [{'name': 'Action for Rehabilitation for Neurological Injury (ARNI)', 'type': 'OTHER', 'description': 'If randomised to upper limb training, a patient will undertake 10 therapy sessions with an instructor from the Action for Rehabilitation for Neurological Injury (ARNI) program during their hospital stay. The last two ARNI-led sessions will be filmed by a nurse/carer on either their own tablet/phone or an i-pad. Participants in the ARNI group will be encouraged to continue doing their personalized exercises while in hospital and continued at home. They will also be given a task-training board to take home', 'armGroupLabels': ['ARNI care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haywards Heath', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Khalid Ali, MBBS FRCP MD', 'role': 'CONTACT'}], 'facility': 'University Hospitals Sussex NHS Foundation Trust - Sussex Rehabilitation Centre', 'geoPoint': {'lat': 50.99769, 'lon': -0.10313}}], 'centralContacts': [{'name': 'Khalid Ali, FRCP PhD', 'role': 'CONTACT', 'email': 'khalid.ali10@nhs.net', 'phone': '01273 523368'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Within 3years of study commencement', 'ipdSharing': 'YES', 'description': 'By request to the Chief Investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Khalid Ali', 'class': 'OTHER'}, 'collaborators': [{'name': 'ARNI Institute for Neurological Rehabilitation (ARNI)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior lecturer in Geriatrics, BSMS', 'investigatorFullName': 'Dr Khalid Ali', 'investigatorAffiliation': 'Brighton & Sussex Medical School'}}}}