Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT06413732
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Dual Task Training in Patients With 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2024-05-09', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': 'Six weeks', 'description': 'It is a scale designed to evaluate balance and determine the risk of falling. It consists of 14 items based on performance of sitting, standing, and posture change. Scores can range from 0 to 56. The higher the score, the better the postural control.'}, {'measure': 'Timed Up and Go Test', 'timeFrame': 'Six weeks', 'description': 'The participant was asked to get up from the chair he was sitting on, walk 3 meters at a safe and normal speed, and then turn back and sit on the chair again. The time was recorded by a stopwatch.'}, {'measure': '10-meter walk test', 'timeFrame': 'Six weeks', 'description': 'The 10-meter walk test (10MWT) is suggested for assessing gait in post-stroke rehabilitation. The participant was instructed to walk at comfortable walking speed a distance of 10 meters. The time was recorded in seconds with a stopwatch.'}, {'measure': '30-Second Chair-Stand Test', 'timeFrame': 'Six weeks', 'description': 'For this test, the participant was seated on a chair with a sitting height of 45-47 cm, with his arms on his chest, and was asked to stand up and sit down as many times as possible within 30 seconds. The score was recorded as zero if the participant could not get up from the chair without using their arms'}, {'measure': 'Short Form 36', 'timeFrame': 'Six weeks', 'description': 'The scale consists of 36 items in the following categories: physical function, social function, physical role, emotional role, mental health, vitality, bodily pain, and general health. Subscales evaluate health between 0 and 100, with 0 indicating poor health and 100 indicating good health.\n\nThe scale consists of 36 items in the following categories: physical function, social function, physical role, emotional role, mental health, vitality, bodily pain, and general health. Subscales evaluate health between 0 and 100, with 0 indicating poor health and 100 indicating good health.\n\nThe scale consists of 36 items in the following categories: physical function, social function, physical role, emotional role, mental health, vitality, bodily pain, and general health. Subscales evaluate health between 0 and 100, with 0 indicating poor health and 100 indicating good health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the effect of dual-task training on gait, balance, and quality of life in individuals with stroke. The study included 30 individuals aged 30-80 years with stroke. All participants were assessed using the 10-meter walk test (10MWT), 10MWT under dual-task interaction (DTI), timed up and go (TUG), 30-Second Chair-Stand Test (30s-CST), Berg Balance Scale (BBS), Short Form 36 (SF-36). Participants were randomized into two groups. Both groups received conventional physiotherapy for approximately 1 hour, five days a week. Group I also received dual-task training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a score of 24 or above on the Mini-Mental State Test,\n* Being able to walk at least 10 meters without using a walking aid\n* Having a total score of 5 on the motor and cognitive sections of the Functional Independence Scale.\n\nExclusion Criteria:\n\n* Neurological and orthopedic problems that could affect motor performance and balance\n* Communication problems\n* Patients who had received Botulinum Toxin injection treatment in the last six months'}, 'identificationModule': {'nctId': 'NCT06413732', 'briefTitle': 'The Effect of Dual Task Training in Patients With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'The Effect of Dual Task Training on Gait, Balance, and Quality of Life in Patients With Stroke', 'orgStudyIdInfo': {'id': 'Karabuk Physiotherapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'The dual-task training program combined with conventional physiotherapy was applied to both groups for approximately 1 hour, 5 days a week.', 'interventionNames': ['Other: Conventional physiotherapy']}, {'type': 'OTHER', 'label': 'Group II', 'description': 'Only conventional physiotherapy was applied to both groups for approximately 1 hour, 5 days a week.', 'interventionNames': ['Other: Conventional physiotherapy']}], 'interventions': [{'name': 'Conventional physiotherapy', 'type': 'OTHER', 'description': 'Conventional physiotherapy was applied for approximately 1 hour, 5 days a week.', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78050', 'city': 'Karabük', 'country': 'Turkey (Türkiye)', 'facility': 'Tarik Ozmen', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Tarik Ozmen', 'investigatorAffiliation': 'Karabuk University'}}}}