- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05290259
Evaluation of the Ballroom Basics for Balance Program
Study Overview
Detailed Description
The primary aim is to examine how balance is impacted by participation in this program.
The 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.
- 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.
- Hypothesis 2: Overground gait speed will increase, time spent in double support will decrease and step extremity ratio will increase from baseline to posttest.
- 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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53706
- UW Sensory Motor Integration Lab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals enrolled in the BB4B program
- Volunteered for the research study
- Scored a 25 or higher on the Montreal Cognitive Assessment (MoCA), indicating that no cognitive impairment is present.
- English speaking
Exclusion Criteria:
- children
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Ballroom Basics for Balance Program
The Ballroom Basics for Balance program is a 12-week physical activity program which uses dance to focus on balance for community dwelling adults.
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The Ballroom Basics for Balance Program is a dance focused exercise program developed by a Physical Therapist in the Madison area.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Activities-Specific Balance Confidence Scale (ABC)
Time Frame: baseline, posttest (up to 14 weeks)
|
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.
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baseline, posttest (up to 14 weeks)
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Change in Falls Efficacy Scale (FES)
Time Frame: baseline, posttest (up to 14 weeks)
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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.
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baseline, posttest (up to 14 weeks)
|
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Change in the Mini-BESTest Score
Time Frame: baseline, posttest (up to 14 weeks)
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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.
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baseline, posttest (up to 14 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Spatiotemporal measures of gait: Gait Speed
Time Frame: baseline, posttest (up to 14 weeks)
|
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. Participants 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. |
baseline, posttest (up to 14 weeks)
|
|
Change in Spatiotemporal measures of gait: percent of cycle in double support
Time Frame: baseline, posttest (up to 14 weeks)
|
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. Participants 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. |
baseline, posttest (up to 14 weeks)
|
|
Change in Spatiotemporal measures of gait: Base of Support measured as horizontal stride width
Time Frame: baseline, posttest (up to 14 weeks)
|
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. Participants 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. |
baseline, posttest (up to 14 weeks)
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|
Change in Spatiotemporal measures of gait: Stride Length
Time Frame: baseline, posttest (up to 14 weeks)
|
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. Participants 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. |
baseline, posttest (up to 14 weeks)
|
|
Change in Spatiotemporal measures of gait: Cadence in steps per minute
Time Frame: baseline, posttest (up to 14 weeks)
|
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. Participants 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. |
baseline, posttest (up to 14 weeks)
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Change in Fall Frequency
Time Frame: baseline, posttest (up to 14 weeks)
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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.
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baseline, posttest (up to 14 weeks)
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Change in Canadian Occupational Performance Measure (COPM): Performance Score
Time Frame: baseline, posttest (up to 14 weeks)
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Total possible range of scores from 1-10 where higher scores indicate higher performance.
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baseline, posttest (up to 14 weeks)
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Change in Canadian Occupational Performance Measure (COPM): Satisfaction Score
Time Frame: baseline, posttest (up to 14 weeks)
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Total possible range of scores from 1-10 where higher scores indicate higher satisfaction.
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baseline, posttest (up to 14 weeks)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Menu Task Score
Time Frame: baseline, posttest (up to 14 weeks)
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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.
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baseline, posttest (up to 14 weeks)
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Change in Functional Gait measured by Performance Assessment of Self-Care Skills (PASS)
Time Frame: baseline, posttest (up to 14 weeks)
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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. Scores 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. |
baseline, posttest (up to 14 weeks)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022-0263
- A176000 (Other Identifier: UW Madison)
- Protocol Version 3/7/2022 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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