Evaluation of the Ballroom Basics for Balance Program

November 8, 2022 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • UW Sensory Motor Integration Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community dwelling adults in the Madison area who self-select into the Ballroom Basics for Balance Program

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Ballroom Dance
The Ballroom Basics for Balance Program is a dance focused exercise program developed by a Physical Therapist in the Madison area.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
baseline, posttest (up to 14 weeks)
Change in Falls Efficacy Scale (FES)
Time Frame: baseline, posttest (up to 14 weeks)
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.
baseline, posttest (up to 14 weeks)
Change in the Mini-BESTest Score
Time Frame: baseline, posttest (up to 14 weeks)
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.
baseline, posttest (up to 14 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
Change in Fall Frequency
Time Frame: baseline, posttest (up to 14 weeks)
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.
baseline, posttest (up to 14 weeks)
Change in Canadian Occupational Performance Measure (COPM): Performance Score
Time Frame: baseline, posttest (up to 14 weeks)
Total possible range of scores from 1-10 where higher scores indicate higher performance.
baseline, posttest (up to 14 weeks)
Change in Canadian Occupational Performance Measure (COPM): Satisfaction Score
Time Frame: baseline, posttest (up to 14 weeks)
Total possible range of scores from 1-10 where higher scores indicate higher satisfaction.
baseline, posttest (up to 14 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Menu Task Score
Time Frame: baseline, posttest (up to 14 weeks)
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.
baseline, posttest (up to 14 weeks)
Change in Functional Gait measured by Performance Assessment of Self-Care Skills (PASS)
Time Frame: baseline, posttest (up to 14 weeks)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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)?

Yes

IPD Plan 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.

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

No

Studies a U.S. FDA-regulated device product

No

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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