Postural BalanceNCT04173936
Community-based Tai Chi, Balance, and Fall Risk
An observational study of Postural Balance and Fall, run by University of North Carolina at Asheville at 1 site in United States.
Trial summary
Aims: Examine the effects of a community Tai Chi program on measures of balance and sensorimotor function. Methods: In a pre-test and post-test design, balance was measured in older adults (N=344; 73.4±7.4 years) with 30-second chair stand, timed-up and go, and 4-stage balance test following a 12-week community-based… Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Postural Balance, Fall, Proprioceptive Disorders
- What is being tested?
- tai chi
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 405 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2014to 15 Jun 2017
- 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 60 to 95 years
- All sexes
- Adult, Older adult
Study population: Older adult volunteers willing to participate in a 12-week community-based tai chi program
Who may be able to join
- age 60 years or older
- ability to independently ambulate
- self-described concern with stability and/or mobility.
Who cannot join
- Neurological diagnosis
- Participants body weight exceeds >450 pounds).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Community-based Tai Chi Program on Balance, Functional Outcomes, and Sensorimotor Function in Older Adults
Aims: Examine the effects of a community Tai Chi program on measures of balance and sensorimotor function.
Methods: In a pre-test and post-test design, balance was measured in older adults (N=344; 73.4±7.4 years) with 30-second chair stand, timed-up and go, and 4-stage balance test following a 12-week community-based tai chi intervention. Balance measures and additional sensorimotor measures, including hip abductor electromechanical delay and hip proprioception, were measured in a smaller sample of older adults (n=11; 67.3±3.7 years).
- Conditions
- Postural Balance, Fall, Proprioceptive Disorders
- Being tested
- tai chi
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tai chiBehavioural
12-week community-based tai chi program
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | All participants enrolled in a 12 week community-based tai chi program. Receives: Behavioral: tai chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-second chair number
The number of times a person can stand up and sit down from a chair in 30 seconds
Measured: 12 weeks
Timed Up and Go
The time (in seconds) for a person to stand from a chair, walk 10 feet, turn 180 degrees and return to sit in the chair
Measured: 12 weeks
4 stage balance test
How long (in seconds) can a person stand with feet together, stand with one foot forward and to the side, stand in tandem (one foot immediately in front of the other, and stand on one foot
Measured: 12 weeks
Hip abductor muscle contraction time
Hip abductor muscle contraction speed as measured as the time (in milliseconds) between the onset of electromyography signal and torque onset from hip muscle abduction
Measured: 12 weeks
Brief-Balance Evaluation System Test
The bBESTest is an 8-item, clinically-based assessment measuring anticipatory postural adjustments, compensatory postural responses, sensory orientation, stability in gait, and the timed up-and-go test.
Measured: 12 weeks
Activities-Specific Balance Confidence Scale (ABC) scale
the ABC scale assesses self-reported confidence during 16 activities related to mobility.
Measured: 12 weeks
Hip joint proprioception error
The magnitude of proprioception error was measured on the participant's dominant lower extremity with a custom-built device25,51 that allows for rotation around the axis of a semi-goniometer to measure proprioception in the transverse plane at the hip joint. Proprioception was assessed by measuring the accuracy of actively pointing a marked line on the second toe to target angles along the semi-goniometer during two conditions, a vision condition and an occluded vision condition.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start11 Jan 2014
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina at Asheville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason R Wingert, Phd, Principal investigator, UNC Asheville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173936
- Sponsor's protocol ID
- 1373542-1
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Community-based Tai Chi Program on Balance, Functional Outcomes, and Sensorimotor Function in Older Adults
- ClinicalTrials.gov ID
- NCT04173936
- Acronym / sponsor ID
- 1373542-1
- Conditions
- Postural Balance, Fall, Proprioceptive Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- University of North Carolina at AshevilleUniversity, hospital or other
- Study start
- 11 Jan 2014 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 22 Nov 2019 (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.
Aims: Examine the effects of a community Tai Chi program on measures of balance and sensorimotor function.
Methods: In a pre-test and post-test design, balance was measured in older adults (N=344; 73.4±7.4 years) with 30-second chair stand, timed-up and go, and 4-stage balance test following a 12-week community-based tai chi intervention. Balance measures and additional sensorimotor measures, including hip abductor electromechanical delay and hip proprioception, were measured in a smaller sample of older adults (n=11; 67.3±3.7 years).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | – | Behavioral: tai chiAll participants enrolled in a 12 week community-based tai chi program. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Older adult volunteers willing to participate in a 12-week community-based tai chi program
Key inclusion criteria (3 listed)
- age 60 years or older
- ability to independently ambulate
- self-described concern with stability and/or mobility.
Key exclusion criteria (2 listed)
- Neurological diagnosis
- Participants body weight exceeds >450 pounds).
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 |
|---|---|---|
| tai chi12-week community-based tai chi program | Behavioural | Tai Chi |
Primary outcome
30-second chair number
Time frame: 12 weeks
The number of times a person can stand up and sit down from a chair in 30 seconds
Timed Up and Go
Time frame: 12 weeks
The time (in seconds) for a person to stand from a chair, walk 10 feet, turn 180 degrees and return to sit in the chair
4 stage balance test
Time frame: 12 weeks
How long (in seconds) can a person stand with feet together, stand with one foot forward and to the side, stand in tandem (one foot immediately in front of the other, and stand on one foot
Hip abductor muscle contraction time
Time frame: 12 weeks
Hip abductor muscle contraction speed as measured as the time (in milliseconds) between the onset of electromyography signal and torque onset from hip muscle abduction
Brief-Balance Evaluation System Test
Time frame: 12 weeks
The bBESTest is an 8-item, clinically-based assessment measuring anticipatory postural adjustments, compensatory postural responses, sensory orientation, stability in gait, and the timed up-and-go test.
Activities-Specific Balance Confidence Scale (ABC) scale
Time frame: 12 weeks
the ABC scale assesses self-reported confidence during 16 activities related to mobility.
Hip joint proprioception error
Time frame: 12 weeks
The magnitude of proprioception error was measured on the participant's dominant lower extremity with a custom-built device25,51 that allows for rotation around the axis of a semi-goniometer to measure proprioception in the transverse plane at the hip joint. Proprioception was assessed by measuring the accuracy of actively pointing a marked line on the second toe to target angles along the semi-goniometer during two conditions, a vision condition and an occluded vision condition.
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 22 Nov 2019.
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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.
Jason R Wingert, Phd principal investigator
UNC Asheville
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 Postural Balance and Fall, run by University of North Carolina at Asheville 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 3 inclusion and 2 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 22 Nov 2019. 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?
30-second chair number (time frame: 12 weeks). The study lists 7 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 22 Nov 2019.