Accidental FallsNCT02188524
The Effect of Training Older Adults in Tai Chi and Compensatory Stepping on Balance Control
A study testing Exercise in people with Accidental Falls, run by Wilfrid Laurier University at 1 site in Canada.
Trial summary
For the duration of 10 weeks, participants will be asked to maintain their current levels of physical activity and to take part in three testing sessions over the course of 10 weeks. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Aug 2015
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65+
Who cannot join
- paralysis
- epilepsy
- cerebral palsy
- multiple sclerosis
- Parkinson's disease
- stroke
Show all 15Show fewer
- any other neurological disorder
- diabetes
- vision problem other than corrective glasses
- cataract surgery
- a balance or coordination problem
- an inner ear disorder
- hearing problems
- constant ringing in your ears
- ear surgery
Trial locations and contacts
1 site in 1 country.
About this study
For the duration of 10 weeks, participants will be asked to maintain their current levels of physical activity and to take part in three testing sessions over the course of 10 weeks. Objective and subjective measurements will be obtained at (week 0), at midpoint (week 5) and after the intervention terminates (week 10). The objective measurements will be taken by inserting pressure sensors directly into the shoe and recording the centre of pressure. Markers will be attached to the surface of the body on the shoulders, feet and belly button and video recording will be used to assess the movement of the centre of mass. The first task requires individuals to stand in one spot with their eyes open, and then eyes closed. Secondly, standing in one place, upon an auditory cue, arms will be lifted to the sky as fast as possible. Lastly, participants will walk around a set of chairs while music plays and when the music stops, this is a cue to stop walking. The Timed-Up-and-Go test requires participants to rise from a seated position, walk 3 meters, turn and return to their original seated position. The Berg Balance Scale requires the completion of a 14 task sequence which evaluates balance ability during seated, and various standing positions as well as transitioning movements. The other measurements taken are collected via a questionnaire about balance confidence level. Upon arrival, participants are required to report whether they have experienced a fall since the last class attended and if yes, a follow-up questionnaire is also required to gain information about the nature of the fall.
Read the detailed description
The main purpose of my research is to explore the benefits of a 10 week Tai Chi and compensatory stepping training program on balance control among older adults by examining static and dynamic postural responses to perturbations before (0 weeks), at midpoint (5 weeks) and after the intervention (10 weeks). This Tai Chi and compensatory stepping program will be compared to a control group that will not participate in any physical activity for 10 weeks, but will be offered the chance to partake in a fall prevention program after the 10 weeks of testing has been completed. The program will be administered twice weekly for thirty minutes each by experienced instructors at a community location (Lab at WLU). The Tai Chi/compensatory stepping group will engage in 50 minutes of Tai Chi exercise followed by 10 minutes of controlled manual perturbations administered for compensatory stepping training. The control group will not be participating in the Tai Chi and compensatory stepping training during the initial 10 weeks of testing, but will be offered the chance to participate in either the SMART fall prevention program, or given other resources for participation in a fall prevention exercise program. Testing for both groups will take place at baseline (week 0), midpoint (week 5) and post-intervention (week 10). We will be assessing balance control by administering the Berg Balance Scale (attached), the Timed-Up-and-Go Test and tracking the variability, minimum and maximum displacements of the centre of pressure (COP), centre of mass (COM) and maximum and minimum displacement between the COM and COP as an indication of instability. The Activities-Specific Balance Confidence Scale questionnaire (attached) will also be administered as an indication of balance confidence. Tighter regulation of COP and COM and as well as a small displacement between the 2 values indicates greater balance control. COP, COM and COP/COM relationship will be measured during three balance tasks. Participants will have pressure insoles directly inserted into their shoes, markers attached with tape to record movement velocity and change in position. For testing, participants will be required to complete 3 tasks. The first is made up of two parts that measure static balance. Participants will stand in one place with their eyes open for 3 trials for 30 seconds each and then they will be asked to repeat the same standing with their eyes closed. The second task is a measure of static balance in response to a self -perturbation, where participants will raise their arms at a high velocity to the sky to offset balance in response to an unexpected auditory cue. The third task will require participants to walk in a circle around a set of chairs and perturb their balance by terminating gait upon an unexpected auditory cue.
- Conditions
- Accidental Falls
- Being tested
- Exercise
- Keywords
- balance, exercise, compensatory stepping, tai chi
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Tai Chi and Compensatory Stepping
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No exercise program |
| Exercise Group | Experimental | exercise program Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of mass - Center of pressure difference
Measured: 0,5,10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilfrid Laurier University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Stephen Perry, Wilfrid Laurier University
- Investigators
- Stephen D Perry, PhD, Principal investigator, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188524
- Sponsor's protocol ID
- HM_TCFP
- Status last verified
- Dec 2016
- First submitted
- 28 May 2014
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training Older Adults in Tai Chi and Compensatory Stepping on Balance Control
- ClinicalTrials.gov ID
- NCT02188524
- Acronym / sponsor ID
- HM_TCFP
- Conditions
- Accidental Falls
- Keywords
- balance, exercise, compensatory stepping, tai chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wilfrid Laurier UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Jul 2014 (estimated)
- 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.
For the duration of 10 weeks, participants will be asked to maintain their current levels of physical activity and to take part in three testing sessions over the course of 10 weeks. Objective and subjective measurements will be obtained at (week 0), at midpoint (week 5) and after the intervention terminates (week 10). The objective measurements will be taken by inserting pressure sensors directly into the shoe and recording the centre of pressure. Markers will be attached to the surface of the body on the shoulders, feet and belly button and video recording will be used to assess the movement of the centre of mass. The first task requires individuals to stand in one spot with their eyes open, and then eyes closed. Secondly, standing in one place, upon an auditory cue, arms will be lifted to the sky as fast as possible. Lastly, participants will walk around a set of chairs while music plays and when the music stops, this is a cue to stop walking. The Timed-Up-and-Go test requires participants to rise from a seated position, walk 3 meters, turn and return to their original seated position. The Berg Balance Scale requires the completion of a 14 task sequence which evaluates balance ability during seated, and various standing positions as well as transitioning movements. The other measurements taken are collected via a questionnaire about balance confidence level. Upon arrival, participants are required to report whether they have experienced a fall since the last class attended and if yes, a follow-up questionnaire is also required to gain information about the nature of the fall.
Detailed description
The main purpose of my research is to explore the benefits of a 10 week Tai Chi and compensatory stepping training program on balance control among older adults by examining static and dynamic postural responses to perturbations before (0 weeks), at midpoint (5 weeks) and after the intervention (10 weeks). This Tai Chi and compensatory stepping program will be compared to a control group that will not participate in any physical activity for 10 weeks, but will be offered the chance to partake in a fall prevention program after the 10 weeks of testing has been completed. The program will be administered twice weekly for thirty minutes each by experienced instructors at a community location (Lab at WLU). The Tai Chi/compensatory stepping group will engage in 50 minutes of Tai Chi exercise followed by 10 minutes of controlled manual perturbations administered for compensatory stepping training. The control group will not be participating in the Tai Chi and compensatory stepping training during the initial 10 weeks of testing, but will be offered the chance to participate in either the SMART fall prevention program, or given other resources for participation in a fall prevention exercise program. Testing for both groups will take place at baseline (week 0), midpoint (week 5) and post-intervention (week 10). We will be assessing balance control by administering the Berg Balance Scale (attached), the Timed-Up-and-Go Test and tracking the variability, minimum and maximum displacements of the centre of pressure (COP), centre of mass (COM) and maximum and minimum displacement between the COM and COP as an indication of instability. The Activities-Specific Balance Confidence Scale questionnaire (attached) will also be administered as an indication of balance confidence. Tighter regulation of COP and COM and as well as a small displacement between the 2 values indicates greater balance control. COP, COM and COP/COM relationship will be measured during three balance tasks. Participants will have pressure insoles directly inserted into their shoes, markers attached with tape to record movement velocity and change in position. For testing, participants will be required to complete 3 tasks. The first is made up of two parts that measure static balance. Participants will stand in one place with their eyes open for 3 trials for 30 seconds each and then they will be asked to repeat the same standing with their eyes closed. The second task is a measure of static balance in response to a self -perturbation, where participants will raise their arms at a high velocity to the sky to offset balance in response to an unexpected auditory cue. The third task will require participants to walk in a circle around a set of chairs and perturb their balance by terminating gait upon an unexpected auditory cue.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No exercise program |
| Exercise Group | Experimental | Other: Exerciseexercise program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age 65+
Key exclusion criteria (15 listed)
- paralysis
- epilepsy
- cerebral palsy
- multiple sclerosis
- Parkinson's disease
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 |
|---|---|---|
| ExerciseTai Chi and Compensatory Stepping | Other | Exercise Group |
Primary outcome
Center of mass - Center of pressure difference
Time frame: 0,5,10 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 7 Dec 2016.
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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.
Stephen D Perry, PhD principal investigator
Wilfrid Laurier University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Accidental Falls, run by Wilfrid Laurier University at 1 site in Canada.
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 1 inclusion and 15 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 7 Dec 2016. 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 Canada. 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?
Center of mass - Center of pressure difference (time frame: 0,5,10 weeks). 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 7 Dec 2016.