Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-09 @ 8:12 AM
Study NCT ID:
NCT01741402
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2012-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Training in a Virtual Environment in Healthy Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-11', 'studyFirstSubmitDate': '2012-11-30', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini-BESTest of Dynamic Balance Evaluation - Balance Evaluation Systems Test', 'timeFrame': 'Up to 3 months', 'description': 'The Mini-BESTest test is a 14-item test that focuses on dynamic balance, specifically anticipatory transitions, postural responses, sensory orientation and dynamic gait.'}], 'secondaryOutcomes': [{'measure': 'Dynamic Gait Index', 'timeFrame': 'Up to 3 months', 'description': 'The scale assesses the ability to adapt the gait during motor tasks with different demands.'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'Up to 3 months', 'description': 'This scale was developed in order to detect mild degrees of cognitive impairment. The instrument assesses different cognitive domains such as attention and concentration, executive functions, memory, language, visuo-constructive skills, calculations, and orientation.'}, {'measure': 'Falls Efficacy Scale - International', 'timeFrame': 'Up to 3 months', 'description': 'The Falls Efficacy Scale-International (FES-I)measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Control posture', 'Gait', 'Virtual Reality', 'Elderly'], 'conditions': ['Elderly']}, 'descriptionModule': {'briefSummary': 'The objective of this work was to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the (1) balance, (2) gait, (3) functionality and (4) cognition ability in older adults. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Thirty-two older adults are randomly in control and experimental group, 16 each one. The study includes only participants scoring at least 24 in the Mini-Mental State Examination to rule out effects of dementia; without the presence of depression, according to the Geriatric Depression Scale of Yesaváge - version 15 (GDS-15 ≤ 5) and scores on the Berg Balance Scale (EBB ≥ 41).', 'detailedDescription': 'The objective of this work is to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on balance, gait, functionality and cognition ability in older adults. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Thirty-two older adults are randomly in control and experimental group, 16 each one. Both groups performed 14 training sessions, twice a week, for seven weeks. Each session is composed of a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups performed more 30 minutes of balance training: the control group performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group performed the balance training with 10 Wii Fit games which stimulated motor and cognitive functions. The main outcome measures are: (1) Mini-BESTest of Dynamic Balance Evaluation; (2) Dynamic Gait Index (DGI); (3) Montreal Cognitive Assessment (MoCA); and (4) Falls Efficacy Scale - International (FES-I).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 60 to 85 years.\n* Absence of other neurological disorders or co-morbidities that may affect gait;\n* Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);\n* Absence of depression (score above 5 on the Geriatric Depression Scale of Yesaváge - version 15);\n* Score on the Berg Balance Scale above 41;\n* Vision and hearing adequate or corrected to normal;\n* Ability to walk independently;\n\nExclusion Criteria:\n\n* Biomechanical alterations (other pathologies) that could compromise the completion of training;\n* Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during balance and gait training;'}, 'identificationModule': {'nctId': 'NCT01741402', 'briefTitle': 'Effects of Training in a Virtual Environment in Healthy Elderly', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effects of Training in a Virtual Environment on the Performance of Gait, Postural Control and Executive Functions in Healthy Elderly', 'orgStudyIdInfo': {'id': 'USPNEC004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Training', 'description': 'The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit.', 'interventionNames': ['Device: Virtual Reality Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical Therapy', 'description': 'The Control Group was trained by conventional Physical Therapy exercises.', 'interventionNames': ['Other: Physical Therapy']}], 'interventions': [{'name': 'Virtual Reality Training', 'type': 'DEVICE', 'description': 'The participants of the study trained 10 balance games during 14 sessions', 'armGroupLabels': ['Virtual Reality Training']}, {'name': 'Physical Therapy', 'type': 'OTHER', 'description': 'Patients of the control group was trained with balance exercises.', 'armGroupLabels': ['Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05360-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Maria Elisa P Piemonte, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Keyte Guedes, MS Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Alexandra M Lobo, MS Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coordination for the Improvement of Higher Education Personnel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}