Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-20 @ 5:57 PM
Study NCT ID:
NCT05524727
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2022-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PEMOCS: Personalized Motor-cognitive Training in Chronic Stroke
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', 'interventionModelDescription': 'RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compliance Rate', 'timeFrame': 'week 12', 'description': 'attended sessions / offered sessions'}, {'measure': 'Adherence Rate', 'timeFrame': 'week 12', 'description': 'attended training time / offered training time'}, {'measure': 'Perceived Motor-Cognitive Task Difficulty', 'timeFrame': 'twice per week, week 0-12', 'description': 'visual analogue scale after each training session, based on cognitive load theory, scale from 1-9, where 9 symbolizes most difficult'}, {'measure': 'Perceived Performance', 'timeFrame': 'twice per week, week 0-12', 'description': 'visual analogue scale after each training session, performance item of the National Aeronautics and Space Administration - Task Load Index, scale from 0 to 20, where 20 symbolizes highest performance'}, {'measure': 'Dose and Content of Usual Care', 'timeFrame': 'once per week, week 0-24', 'description': 'according to weekly questionnaire, based on TIDIeR checklist'}, {'measure': 'Amount and Intensity of General Physical and Cognitive Activity', 'timeFrame': 'once per week, week 0-24', 'description': 'according to weekly questionnaire, based on TIDIeR checklist'}], 'primaryOutcomes': [{'measure': 'Change of Montreal Cognitive Assessment Score', 'timeFrame': 'week 0, week 12 and week 24', 'description': 'Widely used screening tool and cognitive outcome in neurological patients including stroke'}], 'secondaryOutcomes': [{'measure': 'Change of Stroke Impact Scale 3.0 Score', 'timeFrame': 'week 0, week 12 and week 24', 'description': 'Stroke-specific measurement tool assessing patient-reported health-related quality of life'}, {'measure': 'Change of Simple Reaction Test Parameters', 'timeFrame': 'week 0, week 12 and week 24', 'description': 'Widely used reliable and valid neuropsychological test assessing alertness'}, {'measure': 'Change of Trail Making Test A & B Parameters', 'timeFrame': 'week 0, week 12 and week 24', 'description': 'Widely used reliable and valid neuropsychological test assessing processing speed and executive functions'}, {'measure': 'Change of Stroop Interference Test Parameters', 'timeFrame': 'week 0, week 12 and week 24', 'description': 'Widely used reliable and valid neuropsychological test assessing the ability to inhibit the reaction to a more dominant stimulus in favour of the inquired reaction to a less dominant stimulus'}, {'measure': 'Change of N-back test Parameters', 'timeFrame': 'week 0, week 12 and week 24', 'description': 'Widely used reliable and valid neuropsychological test assessing working memory and related cognitive functions'}, {'measure': 'Change of Mental Rotation Test Parameters', 'timeFrame': 'week 0, week 12 and week 24', 'description': 'Measures the ability to mentally rotate abstract objects'}, {'measure': 'Change in Single- and cognitive Dual-Task Timed Up and Go Test Parameters and motor/cognitive dual task costs', 'timeFrame': 'week 0, week 12 and week 24', 'description': 'Widely used, reliable and valid test of mobility and dual-task ability in various populations including stroke.'}, {'measure': 'Change of 10 meter walk test Gait Parameters', 'timeFrame': 'week 0, week 12 and week 24', 'description': 'Widely used test to assess gait speed and spatiotemporal gait parameters.'}, {'measure': 'Change of Outdoor Gait Parameters', 'timeFrame': 'week 0, week 12 and week 24', 'description': 'Assesses walking endurance and spatiotemporal gait parameters under daily-life conditions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognition', 'gait', 'mobility', 'training', 'chronic stroke', 'rehabilitation', 'virtual reality'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '40182756', 'type': 'DERIVED', 'citation': 'Huber SK, Knols RH, Held JPO, Betschart M, Gartmann S, Nauer N, de Bruin ED. PEMOCS: effects of a concept-guided, PErsonalized, MOtor-Cognitive exergame training on cognitive functions and gait in chronic Stroke-a randomized, controlled trial. Front Aging Neurosci. 2025 Mar 13;17:1514594. doi: 10.3389/fnagi.2025.1514594. eCollection 2025.'}, {'pmid': '38965612', 'type': 'DERIVED', 'citation': 'Huber SK, Knols RH, Held JPO, Betschart M, de Bruin ED. PEMOCS: Evaluating the effects of a concept-guided, PErsonalised, MOtor-Cognitive exergame training on cognitive functions and gait in chronic Stroke-study protocol for a randomised controlled trial. Trials. 2024 Jul 4;25(1):451. doi: 10.1186/s13063-024-08283-7.'}]}, 'descriptionModule': {'briefSummary': "In Switzerland, approximately 20'000 persons suffer a stroke each year. Despite carefully considered rehabilitation programs, full recovery is achieved only in a small proportion of stroke survivors (www.swissheart.ch). Studies suggest that motor-cognitive trainings can improve gait, balance, and mobility in chronic stoke survivors. However, little is known about the effect of motor-cognitive trainings on cognitive functioning in chronic stroke.\n\nThe aim of this study is to evaluate the effects of a motor-cognitive training added to usual care compared to usual care alone on cognitive functions, single- and dual-task mobility, gait and health-related quality of life.\n\nIn this single-blind RCT, 38 participants will be allocated randomly to either the intervention group (usual care + motor-cognitive training by means of an exergame for 12 weeks, 2x/week for 30-40 minutes) or the control group (usual care only). Both groups will attend three assessments, at baseline, post-intervention (12 weeks after baseline), and at follow-up (24 weeks after baseline). Global cognitive functioning will be the primary endpoint and a linear mixed model will be used for analysis.\n\nMotor-cognitive trainings, especially exergames, bear the potential for further development of innovative long-term rehabilitation solutions for chronic stroke survivors. Cognitive deficits are a common unmet need restricting daily activities mentioned by chronic stroke survivors. Exergame training following personally tailored progression to generate optimal training load may help addressing this unmet need. Therefore, this study will contribute to the on-going research objective on how to improve the long-term care of stroke patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (\\> 18 years) with chronic stroke (≥ 6 months post-stroke)\n* Stroke: ischemic or haemorrhagic\n* Able to stand for 3 minutes and walk 10 meters, functional ambulation category ≥ 3\n* Able to follow a two-stage command\n* Able to give informed consent as documented by signature\n\nExclusion Criteria:\n\n* Unable or not willing to give informed consent\n* Other neurological diseases (e.g. Parkinson's Disease, multiple sclerosis), except cognitive deficits or dementia\n* Clinical contra-indications for the study intervention\n* Unable to follow the study intervention or the test for the primary endpoint (MoCA), e.g. due to a neglect, aphasia or other language problems\n* Overlapping enrolment in another clinical trial"}, 'identificationModule': {'nctId': 'NCT05524727', 'briefTitle': 'PEMOCS: Personalized Motor-cognitive Training in Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'PEMOCS: Effects of a Concept-guided, PErsonalized, MOtor-Cognitive Training in Chronic Stroke - a RCT', 'orgStudyIdInfo': {'id': '2022-0614'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Usual care + concept-guided, personalized, motor-cognitive training by means of an exergame', 'interventionNames': ['Other: Concept-guided, personalized, motor-cognitive training by means of an exergame']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Usual care only'}], 'interventions': [{'name': 'Concept-guided, personalized, motor-cognitive training by means of an exergame', 'type': 'OTHER', 'description': '12 weeks, two times per week for 30-40min', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8400', 'city': 'Winterthur', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}, {'zip': '8063', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Ambulante Reha Triemli Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}