BalanceNCT05290259
Evaluation of the Ballroom Basics for Balance Program
An observational study of Balance and Gait, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Ballroom Dance
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2022to 25 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community dwelling adults in the Madison area who self-select into the Ballroom Basics for Balance Program
Who may be able to join
- 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
Who cannot join
- children
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Sensory Motor Integration Lab
Madison, Wisconsin, 53706
About this study
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.
Read the 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
- Being tested
- Ballroom Dance
- Keywords
- ballroom dance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ballroom DanceOther
The Ballroom Basics for Balance Program is a dance focused exercise program developed by a Physical Therapist in the Madison area.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ballroom Dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Activities-Specific Balance Confidence Scale (ABC)
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.
Measured: baseline, posttest (up to 14 weeks)
Change in Falls Efficacy Scale (FES)
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.
Measured: baseline, posttest (up to 14 weeks)
Change in the Mini-BESTest Score
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.
Measured: baseline, posttest (up to 14 weeks)
Secondary outcomes (8)
Change in Spatiotemporal measures of gait: Gait Speed
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.
Measured: baseline, posttest (up to 14 weeks)
Change in Spatiotemporal measures of gait: percent of cycle in double support
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.
Measured: baseline, posttest (up to 14 weeks)
Change in Spatiotemporal measures of gait: Base of Support measured as horizontal stride width
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.
Measured: baseline, posttest (up to 14 weeks)
Change in Spatiotemporal measures of gait: Stride Length
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.
Measured: baseline, posttest (up to 14 weeks)
Change in Spatiotemporal measures of gait: Cadence in steps per minute
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.
Measured: baseline, posttest (up to 14 weeks)
Change in Fall Frequency
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.
Measured: baseline, posttest (up to 14 weeks)
Change in Canadian Occupational Performance Measure (COPM): Performance Score
Total possible range of scores from 1-10 where higher scores indicate higher performance.
Measured: baseline, posttest (up to 14 weeks)
Change in Canadian Occupational Performance Measure (COPM): Satisfaction Score
Total possible range of scores from 1-10 where higher scores indicate higher satisfaction.
Measured: baseline, posttest (up to 14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start12 Mar 2022
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen Pickett, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290259
- Sponsor's protocol ID
- 2022-0263
- Other IDs
- A176000, Protocol Version 3/7/2022
- Status last verified
- Nov 2022
- First submitted
- 11 Mar 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ballroom Basics for Balance Program
- ClinicalTrials.gov ID
- NCT05290259
- Acronym / sponsor ID
- 2022-0263
- Keywords
- ballroom dance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ballroom Basics for Balance Program | – | Other: Ballroom DanceThe Ballroom Basics for Balance program is a 12-week physical activity program which uses dance to focus on balance for community dwelling adults. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community dwelling adults in the Madison area who self-select into the Ballroom Basics for Balance Program
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ballroom DanceThe Ballroom Basics for Balance Program is a dance focused exercise program developed by a Physical Therapist in the Madison area. | Other | Ballroom Basics for Balance Program |
Primary outcome
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.
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.
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.
8 secondary outcomes
Change in Spatiotemporal measures of gait: Gait Speed
Time frame: 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)
Change in Spatiotemporal measures of gait: Base of Support measured as horizontal stride width
Time frame: baseline, posttest (up to 14 weeks)
Change in Spatiotemporal measures of gait: Stride Length
Time frame: 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)
Change in Fall Frequency
Time frame: baseline, posttest (up to 14 weeks)
Change in Canadian Occupational Performance Measure (COPM): Performance Score
Time frame: baseline, posttest (up to 14 weeks)
Change in Canadian Occupational Performance Measure (COPM): Satisfaction Score
Time frame: baseline, posttest (up to 14 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Balance
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Active, not recruiting
Comparative Effect of Dual Task Training and Rhythmic Stabilization in Knee Osteoarthritis Patients
Knee Osteoarthritis
Not yet recruiting
Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke
Hemiparesis, Ischemic Stroke
Active, not recruiting
Comparative Effects of Vestibular Rehabilitation With and Without Cervical JPS Training in Stroke Patients
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Pickett, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Balance and Gait, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Activities-Specific Balance Confidence Scale (ABC) (time frame: baseline, posttest (up to 14 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.