Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-26 @ 7:29 PM
Study NCT ID:
NCT04488692
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2020-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Functional Training in Acute Stroke Inpatient Ward
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-22', 'studyFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2020-07-23', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postural Assessment Scale for Stroke Patient (PASS)', 'timeFrame': 'Baseline', 'description': 'The total score range is 0 to 36 points. Higher score indicate better performance.'}, {'measure': 'Postural Assessment Scale for Stroke Patient (PASS)', 'timeFrame': 'up to 2 weeks', 'description': 'The total score range is 0 to 36 points. Higher score indicate better performance.'}, {'measure': 'Postural Assessment Scale for Stroke Patient (PASS)', 'timeFrame': 'at 3 months post stroke', 'description': 'The total score range is 0 to 36 points. Higher score indicate better performance.'}, {'measure': 'Barthel index (BI)', 'timeFrame': 'Baseline', 'description': 'The total score range is 0 to 100 points. Higher score indicate better performance.'}, {'measure': 'Barthel index (BI)', 'timeFrame': 'up to 2 weeks', 'description': 'The total score range is 0 to 100 points. Higher score indicate better performance.'}, {'measure': 'Barthel index (BI)', 'timeFrame': 'at 3 months post stroke', 'description': 'The total score range is 0 to 100 points. Higher score indicate better performance.'}], 'secondaryOutcomes': [{'measure': 'Usual gait speed', 'timeFrame': 'Baseline', 'description': 'meters per second. Higher score indicate better performance.'}, {'measure': 'Usual gait speed', 'timeFrame': 'up to 2 weeks', 'description': 'meters per second. Higher score indicate better performance.'}, {'measure': 'Usual gait speed', 'timeFrame': 'at 3 months post stroke', 'description': 'meters per second. Higher score indicate better performance.'}, {'measure': 'Mobility Scale for Acute Stroke (MSAS)', 'timeFrame': 'Baseline', 'description': 'The total score range is 6 to 36 points. Higher score indicate better performance.'}, {'measure': 'Mobility Scale for Acute Stroke (MSAS)', 'timeFrame': 'up to 2 weeks', 'description': 'The total score range is 6 to 36 points. Higher score indicate better performance.'}, {'measure': 'Mobility Scale for Acute Stroke (MSAS)', 'timeFrame': 'at 3 months post stroke', 'description': 'The total score range is 6 to 36 points. Higher score indicate better performance.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Stroke']}, 'referencesModule': {'references': [{'pmid': '8087974', 'type': 'BACKGROUND', 'citation': 'Adams HP Jr, Brott TG, Crowell RM, Furlan AJ, Gomez CR, Grotta J, Helgason CM, Marler JR, Woolson RF, Zivin JA, et al. Guidelines for the management of patients with acute ischemic stroke. A statement for healthcare professionals from a special writing group of the Stroke Council, American Heart Association. Circulation. 1994 Sep;90(3):1588-601. doi: 10.1161/01.cir.90.3.1588. No abstract available.'}, {'pmid': '26888985', 'type': 'BACKGROUND', 'citation': 'Bernhardt J, Churilov L, Ellery F, Collier J, Chamberlain J, Langhorne P, Lindley RI, Moodie M, Dewey H, Thrift AG, Donnan G; AVERT Collaboration Group. Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT). Neurology. 2016 Jun 7;86(23):2138-45. doi: 10.1212/WNL.0000000000002459. Epub 2016 Feb 17.'}, {'pmid': '18174489', 'type': 'BACKGROUND', 'citation': 'Bernhardt J, Dewey H, Thrift A, Collier J, Donnan G. A very early rehabilitation trial for stroke (AVERT): phase II safety and feasibility. Stroke. 2008 Feb;39(2):390-6. doi: 10.1161/STROKEAHA.107.492363. Epub 2008 Jan 3.'}, {'pmid': '22144725', 'type': 'BACKGROUND', 'citation': 'Diserens K, Moreira T, Hirt L, Faouzi M, Grujic J, Bieler G, Vuadens P, Michel P. Early mobilization out of bed after ischaemic stroke reduces severe complications but not cerebral blood flow: a randomized controlled pilot trial. Clin Rehabil. 2012 May;26(5):451-9. doi: 10.1177/0269215511425541. Epub 2011 Dec 2.'}, {'pmid': '1866749', 'type': 'BACKGROUND', 'citation': 'Indredavik B, Bakke F, Solberg R, Rokseth R, Haaheim LL, Holme I. Benefit of a stroke unit: a randomized controlled trial. Stroke. 1991 Aug;22(8):1026-31. doi: 10.1161/01.str.22.8.1026.'}, {'pmid': '22466792', 'type': 'BACKGROUND', 'citation': 'Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012 Oct;26(8):923-31. doi: 10.1177/1545968312440745. Epub 2012 Mar 30.'}, {'pmid': '15472114', 'type': 'BACKGROUND', 'citation': 'Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004 Nov;35(11):2529-39. doi: 10.1161/01.STR.0000143153.76460.7d. Epub 2004 Oct 7.'}, {'pmid': '30321906', 'type': 'BACKGROUND', 'citation': 'Langhorne P, Collier JM, Bate PJ, Thuy MN, Bernhardt J. Very early versus delayed mobilisation after stroke. Cochrane Database Syst Rev. 2018 Oct 16;10(10):CD006187. doi: 10.1002/14651858.CD006187.pub3.'}, {'pmid': '28967376', 'type': 'BACKGROUND', 'citation': 'Langhorne P, Wu O, Rodgers H, Ashburn A, Bernhardt J. A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial. Health Technol Assess. 2017 Sep;21(54):1-120. doi: 10.3310/hta21540.'}, {'pmid': '20130401', 'type': 'BACKGROUND', 'citation': 'Langhorne P, Stott D, Knight A, Bernhardt J, Barer D, Watkins C. Very early rehabilitation or intensive telemetry after stroke: a pilot randomised trial. Cerebrovasc Dis. 2010;29(4):352-60. doi: 10.1159/000278931. Epub 2010 Jan 30.'}, {'pmid': '25603539', 'type': 'BACKGROUND', 'citation': 'Lee KB, Lim SH, Kim KH, Kim KJ, Kim YR, Chang WN, Yeom JW, Kim YD, Hwang BY. Six-month functional recovery of stroke patients: a multi-time-point study. Int J Rehabil Res. 2015 Jun;38(2):173-80. doi: 10.1097/MRR.0000000000000108.'}, {'pmid': '28143920', 'type': 'BACKGROUND', 'citation': 'Stinear CM, Byblow WD, Ackerley SJ, Smith MC, Borges VM, Barber PA. Proportional Motor Recovery After Stroke: Implications for Trial Design. Stroke. 2017 Mar;48(3):795-798. doi: 10.1161/STROKEAHA.116.016020. Epub 2017 Jan 31.'}, {'pmid': '23680682', 'type': 'BACKGROUND', 'citation': 'Sundseth A, Thommessen B, Ronning OM. Early mobilization after acute stroke. J Stroke Cerebrovasc Dis. 2014 Mar;23(3):496-9. doi: 10.1016/j.jstrokecerebrovasdis.2013.04.012. Epub 2013 May 13.'}, {'pmid': '17876069', 'type': 'BACKGROUND', 'citation': 'Verheyden G, Nieuwboer A, De Wit L, Thijs V, Dobbelaere J, Devos H, Severijns D, Vanbeveren S, De Weerdt W. Time course of trunk, arm, leg, and functional recovery after ischemic stroke. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):173-9. doi: 10.1177/1545968307305456. Epub 2007 Sep 17.'}, {'pmid': '3973842', 'type': 'BACKGROUND', 'citation': 'Wade DT, Wood VA, Hewer RL. Use of hospital resources by acute stroke patients. J R Coll Physicians Lond. 1985 Jan;19(1):48-52. No abstract available.'}, {'pmid': '28747763', 'type': 'BACKGROUND', 'citation': 'Xu T, Yu X, Ou S, Liu X, Yuan J, Chen Y. Efficacy and Safety of Very Early Mobilization in Patients with Acute Stroke: A Systematic Review and Meta-analysis. Sci Rep. 2017 Jul 26;7(1):6550. doi: 10.1038/s41598-017-06871-z.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the difference between two models of an early intervention program (focused on mobility function) in the functional recovery 3 months post stroke in a group of patients with acute ischemic stroke while in acute inpatient ward hospitalization.', 'detailedDescription': "Patients with acute stroke admit into an acute inpatient ward who meet study criteria and provide institutional-reviewed consent form will be randomly assigned into either model 1 or model 2 of an early functional training program. Participants in model 1 group will receive 2 sessions of functional training per day whereas those in model 2 group will receive 1 session of functional training and 1 session of friendly visit and education per day. The following outcomes will be measured at admission, at discharge and at 3 months post stroke: Barthel index (BI), Postural Assessment Scale for Stroke (PASS), Mobility Scale for Acute Stroke (MASA), and usual gait speed (UGS). The rater is blinded to participants' group membership."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with acute ischemic stroke / ICH\n* referred for early rehabilitation,\n* aged 20 years or more,\n\nExclusion Criteria:\n\n* able to walk independently and safely at admission,\n* unable to understand three simple comments,\n* unable to recovery even with appropriate medical management,\n* serious condition require ICU care,\n* terminal illness for hospice care,\n* waiting to transfer to long term care facilities'}, 'identificationModule': {'nctId': 'NCT04488692', 'briefTitle': 'Early Functional Training in Acute Stroke Inpatient Ward', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'The Effect of Two Models of an Early Intervention Program on Functional Recovery at Three Months to Acute Stroke Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CS19166'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Model 1', 'description': 'Participants will receive 2 sessions of functional training per day, 15-min per session.', 'interventionNames': ['Other: Early intervention (Mobility functional training)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Model 2', 'description': 'Participants will receive 1 session of functional training and 1 session of sham intervention (therapist visiting and education) per day, 15-min per session.', 'interventionNames': ['Other: Early intervention (Mobility functional training)', 'Other: Sham intervention']}], 'interventions': [{'name': 'Early intervention (Mobility functional training)', 'type': 'OTHER', 'description': 'functional training focused on mobility (bed mobility, sitting balance, standing balance, and ambulation)', 'armGroupLabels': ['Model 1', 'Model 2']}, {'name': 'Sham intervention', 'type': 'OTHER', 'description': 'friendly visit and education', 'armGroupLabels': ['Model 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '402', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Ching-Yi Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ching-Yi Wang', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}