Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-02 @ 12:43 AM
Study NCT ID:
NCT05290259
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Ballroom Basics for Balance Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-08', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-03-11', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Menu Task Score', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': 'The Menu Task is a performance based screening tool used to examine functional cognition. Total scores will range between 0-12 where higher scores indicate increased functional cognition.'}, {'measure': 'Change in Functional Gait measured by Performance Assessment of Self-Care Skills (PASS)', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': 'Specific components of the the PASS assessment will be administered to examine changes in performance of activities of daily living. The PASS consists of 26 activities of daily living and is designed to allow for a client-centered, performance-based means of objectively assessing occupation-based interventions. A modified version of the shopping component of the PASS assessment will be performed in an instrumented environment (SMIL kitchen) to allow for quantification of kinetic and kinematic measures relative to the performance of these tasks.\n\nScores will range from 0-3 on individual metrics where higher numbers indicate increased independence, safety, and adequacy. Spatiotemporal gait measures will be used for quantitative scoring.'}], 'primaryOutcomes': [{'measure': 'Change in Activities-Specific Balance Confidence Scale (ABC)', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': '16-item survey of how confident one is with balance, scored as a percentage between 0-100 where higher percentage indicates increased confidence in balance.'}, {'measure': 'Change in Falls Efficacy Scale (FES)', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': "10-item survey that measures confidence in one's own ability to complete daily activities without falling on a scale of 1-10 where lowers scores indicate more extreme confidence."}, {'measure': 'Change in the Mini-BESTest Score', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': 'The mini-BESTest will be used to assess balance. This 14-item, clinical battery is used to assess balance in four component areas (anticipatory transitions, postural response, sensory orientation and dynamic gait) and provides a single number summary of balance performance (total possible range of scores 0-30), higher scores indicate better balance.'}], 'secondaryOutcomes': [{'measure': 'Change in Spatiotemporal measures of gait: Gait Speed', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': 'The GaitRite® mat is a 14 foot portable electronic walkway, embedded with sensors to enable the measurement spatiotemporal variables of gait such as cadence, normalized velocity, stride length, base of support, and percent of cycle in double support.\n\nParticipants will begin at a starting point two meters from the mat, then walk toward and step onto the mat to continue walking until they achieve the stop line located two meters off of the opposite side of the mat. Data will be collected for forward preferred speed, backward preferred speed, forward fast, tandem (one foot directly in front of the other (heel to toe)) and dual task (naming items in a specified category) gait. Each participant will complete up to 10 trials for each condition.'}, {'measure': 'Change in Spatiotemporal measures of gait: percent of cycle in double support', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': 'The GaitRite® mat is a 14 foot portable electronic walkway, embedded with sensors to enable the measurement spatiotemporal variables of gait such as cadence, normalized velocity, stride length, base of support, and percent of cycle in double support.\n\nParticipants will begin at a starting point two meters from the mat, then walk toward and step onto the mat to continue walking until they achieve the stop line located two meters off of the opposite side of the mat. Data will be collected for forward preferred speed, backward preferred speed, forward fast, tandem (one foot directly in front of the other (heel to toe)) and dual task (naming items in a specified category) gait. Each participant will complete up to 10 trials for each condition.'}, {'measure': 'Change in Spatiotemporal measures of gait: Base of Support measured as horizontal stride width', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': 'The GaitRite® mat is a 14 foot portable electronic walkway, embedded with sensors to enable the measurement spatiotemporal variables of gait such as cadence, normalized velocity, stride length, base of support, and percent of cycle in double support.\n\nParticipants will begin at a starting point two meters from the mat, then walk toward and step onto the mat to continue walking until they achieve the stop line located two meters off of the opposite side of the mat. Data will be collected for forward preferred speed, backward preferred speed, forward fast, tandem (one foot directly in front of the other (heel to toe)) and dual task (naming items in a specified category) gait. Each participant will complete up to 10 trials for each condition.'}, {'measure': 'Change in Spatiotemporal measures of gait: Stride Length', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': 'The GaitRite® mat is a 14 foot portable electronic walkway, embedded with sensors to enable the measurement spatiotemporal variables of gait such as cadence, normalized velocity, stride length, base of support, and percent of cycle in double support.\n\nParticipants will begin at a starting point two meters from the mat, then walk toward and step onto the mat to continue walking until they achieve the stop line located two meters off of the opposite side of the mat. Data will be collected for forward preferred speed, backward preferred speed, forward fast, tandem (one foot directly in front of the other (heel to toe)) and dual task (naming items in a specified category) gait. Each participant will complete up to 10 trials for each condition.'}, {'measure': 'Change in Spatiotemporal measures of gait: Cadence in steps per minute', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': 'The GaitRite® mat is a 14 foot portable electronic walkway, embedded with sensors to enable the measurement spatiotemporal variables of gait such as cadence, normalized velocity, stride length, base of support, and percent of cycle in double support.\n\nParticipants will begin at a starting point two meters from the mat, then walk toward and step onto the mat to continue walking until they achieve the stop line located two meters off of the opposite side of the mat. Data will be collected for forward preferred speed, backward preferred speed, forward fast, tandem (one foot directly in front of the other (heel to toe)) and dual task (naming items in a specified category) gait. Each participant will complete up to 10 trials for each condition.'}, {'measure': 'Change in Fall Frequency', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': 'At baseline and posttest, participants will be asked to estimate their fall frequency (none, 1 time, 2-10 times, weekly, daily) in the last 2 weeks, 1 month, and 6 months.'}, {'measure': 'Change in Canadian Occupational Performance Measure (COPM): Performance Score', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': 'Total possible range of scores from 1-10 where higher scores indicate higher performance.'}, {'measure': 'Change in Canadian Occupational Performance Measure (COPM): Satisfaction Score', 'timeFrame': 'baseline, posttest (up to 14 weeks)', 'description': 'Total possible range of scores from 1-10 where higher scores indicate higher satisfaction.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ballroom dance'], 'conditions': ['Balance', 'Gait']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effectiveness of the 12-week Ballroom Basics for Balance (BB4B). 20 older adults in the Madison, Wisconsin area who self-select into the Ballroom Basics for Balance Program will be on study for the 12 week intervention plus pre- and post-intervention tests within 10 days for program start and completion.', 'detailedDescription': 'The primary aim is to examine how balance is impacted by participation in this program.\n\nThe secondary aims are to examine how the program impacts metrics of gait, fall frequency, occupational performance, functional cognition and functional gait. The investigators hypothesize that participation in this program will lead to significant within-subject changes from pre to post-test in both our primary and secondary outcomes.\n\n* Hypothesis 1: Balance, as measured by the MiniBESTest, will improve (score will increase) from baseline to posttest for individuals who participate in the 12-week BB4B program.\n* Hypothesis 2: Overground gait speed will increase, time spent in double support will decrease and step extremity ratio will increase from baseline to posttest.\n* Hypothesis 3: Measures of occupational performance, functional cognition and functional gait will significantly improve from baseline to posttest. Fall frequency will improve non-significantly due to the limited number of participants in the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community dwelling adults in the Madison area who self-select into the Ballroom Basics for Balance Program', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals enrolled in the BB4B program\n* Volunteered for the research study\n* Scored a 25 or higher on the Montreal Cognitive Assessment (MoCA), indicating that no cognitive impairment is present.\n* English speaking\n\nExclusion Criteria:\n\n* children'}, 'identificationModule': {'nctId': 'NCT05290259', 'briefTitle': 'Evaluation of the Ballroom Basics for Balance Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Evaluation of the Ballroom Basics for Balance Program', 'orgStudyIdInfo': {'id': '2022-0263'}, 'secondaryIdInfos': [{'id': 'A176000', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 3/7/2022', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ballroom Basics for Balance Program', 'description': 'The Ballroom Basics for Balance program is a 12-week physical activity program which uses dance to focus on balance for community dwelling adults.', 'interventionNames': ['Other: Ballroom Dance']}], 'interventions': [{'name': 'Ballroom Dance', 'type': 'OTHER', 'description': 'The Ballroom Basics for Balance Program is a dance focused exercise program developed by a Physical Therapist in the Madison area.', 'armGroupLabels': ['Ballroom Basics for Balance Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW Sensory Motor Integration Lab', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Kristen Pickett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Dr. Pickett will be responsible for deciding when/to whom to disseminate coded data, and will work with other researchers if necessary to confirm that they have proper IRB approval/etc., as necessary. Required UW-Madison IRB approval would be obtained prior to the release of any data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}