Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2026-06-21 @ 4:54 PM
Study NCT ID:
NCT02073318
Status:
COMPLETED
Last Update Posted:
2014-02-27
First Post:
2011-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Balance Training in Older Adults With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-25', 'studyFirstSubmitDate': '2011-01-20', 'studyFirstSubmitQcDate': '2014-02-25', 'lastUpdatePostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go test', 'timeFrame': 'baseline, post-treatment, 1-month follow up', 'description': 'Change from Baseline of Timed Up and Go test'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'baseline, post-treatment, 1-month follow up', 'description': 'Change from Baseline of Berg Balance Scale'}, {'measure': 'walking speed', 'timeFrame': 'baseline, post-treatment, 1-month follow up', 'description': 'Change from Baseline of walking speed'}], 'secondaryOutcomes': [{'measure': '30-s chair-stand test', 'timeFrame': 'baseline, post-treatment, 1-month follow up', 'description': 'Change from Baseline of 30-s chair-stand test'}, {'measure': 'chair sit-and-reach test', 'timeFrame': 'baseline, post-treatment, 1-month follow up', 'description': 'Change from Baseline of chair sit-and-reach test'}, {'measure': 'Saint Louis University mental status examination', 'timeFrame': 'baseline, post-treatment, 1-month follow up', 'description': 'Change from Baseline of Saint Louis University mental status examination'}, {'measure': 'Barthel index', 'timeFrame': 'baseline, post-treatment, 1-month follow up', 'description': 'Change from Baseline of Barthel index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': "Purpose -To investigate whether older adults with dementia who have balance and gait problems can improve their balance and gait function after an individualized 4-week tasks-oriented balance training with sensory manipulation.\n\nHypothesis\n\n-There is significant difference of Timed Up and Go Test, Berg Balance Scale, walking speed, 30-s chair-stand test, Chair sit-and-reach test and Barthel Index between dementia patients who received tasks-oriented balance training and those didn't receive after 4-weeks training and one month follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient provides oral consent, and written consent obtains from next of kin\n* Older than 65 years\n* Diagnosis of dementia, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or The International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)\n* Can follow order to complete the screening test(Timed Up and Go test)\n* Has balance and gait problems\n* Can standing independently with/without assistive device or can standing with minimal assistance\n\nExclusion Criteria:\n\n* Newly developed cardiopulmonary disease and other exercise contraindications\n* Other neuromuscular or musculoskeletal disease that might affect the outcome(ex. Recent stroke, fracture or orthopedic surgery)'}, 'identificationModule': {'nctId': 'NCT02073318', 'briefTitle': 'Effects of Balance Training in Older Adults With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effects of Task-oriented Balance Training in Institutionalized Older Adults With Dementia', 'orgStudyIdInfo': {'id': '201011010RB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Balance training', 'interventionNames': ['Other: Task-oriented balance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control group received 4 weeks upper extremities exercise in sitting position', 'interventionNames': ['Other: Upper extremities exercise']}], 'interventions': [{'name': 'Task-oriented balance training', 'type': 'OTHER', 'description': '4 weeks individualized task-oriented balance training, twice a week and 1 hour each session', 'armGroupLabels': ['Balance training']}, {'name': 'Upper extremities exercise', 'type': 'OTHER', 'description': '4 weeks upper extremities exercise in sitting position, twice a week and 1 hour each session\n\nweeks', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886-108-67', 'city': 'Taipei', 'state': 'Taipei', 'country': 'Taiwan', 'facility': "The Catholic Foundation of Alzheimer's Disease and Related Dementia St. Joseph Home for Alzheimer's Disease and Related Dementia"}], 'overallOfficials': [{'name': 'Ming-Hsia Hu, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'School of Physical Therapy, National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}