Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT02491203
Status:
COMPLETED
Last Update Posted:
2018-11-28
First Post:
2015-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-stroke Upper Limb Rehabilitation Using Telerehabilitation Interactive Virtual Reality System in the Patient's Home
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-27', 'studyFirstSubmitDate': '2015-06-13', 'studyFirstSubmitQcDate': '2015-07-06', 'lastUpdatePostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Economic evaluation at 4 weeks after intervention', 'timeFrame': 'at 4 weeks after intervention', 'description': 'Cost-effectiveness analysis (CEA) comparing the intervention with usual care'}], 'primaryOutcomes': [{'measure': 'Change from Baseline in Upper limb motor control at 4 weeks', 'timeFrame': 'baseline and four weeks after intervention', 'description': 'as measured using the Fugl-Meyer Assessment-UE (FMA-UE).'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in quality of life at 4 weeks', 'timeFrame': 'At intake into the study ( post-stroke; chronic phase) and four weeks after intervention', 'description': 'measured using the Stroke Impact Scale-16, a stroke-specific, self-report, health status measure featuring 16 items capturing daily activities'}, {'measure': 'Change from Baseline in Upper limb motor control at 4 weeks', 'timeFrame': 'At intake into the study ( post-stroke; chronic phase) and four weeks after intervention', 'description': 'Box and Block test.'}, {'measure': 'Change from Baseline in Upper limb function at 4 weeks', 'timeFrame': 'At intake into the study ( post-stroke; chronic phase) and four weeks after intervention', 'description': 'Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Virtual reality', 'telerehabilitation', 'Stroke rehabilitation'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '19233729', 'type': 'BACKGROUND', 'citation': 'Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009 Apr;8(4):355-69. doi: 10.1016/S1474-4422(09)70025-0. Epub 2009 Feb 21.'}, {'pmid': '22179539', 'type': 'BACKGROUND', 'citation': 'Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.'}, {'pmid': '15947263', 'type': 'BACKGROUND', 'citation': "Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9."}, {'type': 'BACKGROUND', 'citation': "Richards C. Trajectoires de services de réadaptation post-AVC. Un continuum centré sur la personne: Comité d'experts sur l'offre de services de réadaptation post-AVC;2013"}, {'pmid': '23319181', 'type': 'BACKGROUND', 'citation': 'Langan J, Delave K, Phillips L, Pangilinan P, Brown SH. Home-based telerehabilitation shows improved upper limb function in adults with chronic stroke: a pilot study. J Rehabil Med. 2013 Feb;45(2):217-20. doi: 10.2340/16501977-1115.'}, {'type': 'BACKGROUND', 'citation': 'Dawson AS KJ MA, Foley N, Teasell R. Chapter 5: Stroke Rehabilitation. In: Lindsay MP GG BM, Phillips S, ed. Canadian Best Practice Recommendations for Stroke Care: Canadian Stroke Best Practices and Standards Working Group; 2013.'}, {'pmid': '36166289', 'type': 'DERIVED', 'citation': 'Hernandez A, Bubyr L, Archambault PS, Higgins J, Levin MF, Kairy D. Virtual Reality-Based Rehabilitation as a Feasible and Engaging Tool for the Management of Chronic Poststroke Upper-Extremity Function Recovery: Randomized Controlled Trial. JMIR Serious Games. 2022 Sep 27;10(3):e37506. doi: 10.2196/37506.'}]}, 'descriptionModule': {'briefSummary': 'Stroke is a leading cause of death and long-term disability worldwide and its incidence is on the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a significant long-term impact on activities of daily living, leisure activities and work. The capacity for recovery following a stroke depends on several factors, including the extent of the initial neurological damage, spontaneous recovery and rehabilitation, with possible recovery even years after the stroke. Unfortunately, accessibility of much needed rehabilitation services poststroke often remains limited, both in terms of intensity and duration, as reported in a recent report on post-stroke rehabilitation services in Quebec (Richard, 2013) Recent evidence suggests that homebased telerehabilitation (TR) is a viable approach for upper limb training post-stroke when rehabilitation services are not available. Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013 recommends home-based patient monitoring be used when frequent monitoring is needed and face-to-face visits are not available. Hence, The investigators have developed and propose to examine the use of a TR system that allows upper limb rehabilitation with ongoing off-line monitoring, to be used after usual poststroke rehabilitation is completed and services are no longer offered.', 'detailedDescription': 'More specifically, the objective of the proposed study is to assess the impact, in terms of motor recovery, function,quality of life, compliance, safety and cost, of a novel, patient-centered home-based tailored TR program using an affordable virtual reality system for upper-limb rehabilitation post-stroke. Such a system, combined with remote off-line monitoring could allow patients to take charge and pursue their rehabilitation beyond current services, maximizing their potential for recovery.\n\nA single-blind two-arm randomized clinical trial (RCT) is proposed for this study with participants who have had a stroke randomly allocated to: (1) 4-week training with home-based tele-rehabilitation (TR) system (see intervention below).i.e. treatment group or (2) 4-week written home exercise program provided by a clinician, i.e. exercise control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic or hemorrhagic stroke (does not have to be a first time stroke);\n* Mild to moderate upper limb impairment (score 3-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);\n* At least 6 months post stroke;\n* No longer receiving rehabilitation services; and (5) living in an area where high speed Internet access is available.\n\nExclusion Criteria:\n\n* Being medically unstable;\n* Severe cognitive or communication deficits;\n* Visual impairments;\n* Severe balance deficits limiting sitting safely independently;\n* Shoulder pain;\n* Previous upper limb impairment limiting potential recovery.'}, 'identificationModule': {'nctId': 'NCT02491203', 'briefTitle': "Post-stroke Upper Limb Rehabilitation Using Telerehabilitation Interactive Virtual Reality System in the Patient's Home", 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': "Maximizing Post-stroke Upper Limb Rehabilitation Using a Novel Telerehabilitation Interactive Virtual Reality System in the Patient's Home", 'orgStudyIdInfo': {'id': 'CRIR-937-0214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'All study participants in the control group will receive a 4-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program.'}, {'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation system', 'description': "Participants in the experimental group will receive four weeks written home exercise program provided by a clinician, i.e. usual care discharge home program plus virtual reality (VR) and telerehabilitation system. The intensity and choice of game for the home program will be determined by the therapist based on the patient's abilities, interests, motivation and fatigue. The patient's performance for the VR home program will be monitored asynchronously and the program adapted to ensure it remains at an appropriate level for the patient.", 'interventionNames': ['Other: Telerehabilitation system']}], 'interventions': [{'name': 'Telerehabilitation system', 'type': 'OTHER', 'description': 'Usual care plus home-based virtual reality telerehabilitation system.', 'armGroupLabels': ['Telerehabilitation system']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3N 1X7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'University of Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Dahlia Kairy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dahlia Kairy', 'investigatorAffiliation': 'Université de Montréal'}}}}