The Effect of Training Older Adults in Tai Chi and Compensatory Stepping on Balance Control

December 6, 2016 updated by: Dr. Stephen Perry, Wilfrid Laurier University
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.

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 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 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.
Interventional

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.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3C5
        • Biomechanics 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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- age 65+

Exclusion Criteria:

  • paralysis
  • epilepsy
  • cerebral palsy
  • multiple sclerosis
  • Parkinson's disease
  • stroke
  • 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

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

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
No Intervention: Control Group
No exercise program
Experimental: Exercise Group
exercise program
Other: Exercise
Tai Chi and Compensatory Stepping

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
Time Frame
Center of mass - Center of pressure difference
Time Frame: 0,5,10 weeks
0,5,10 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.
Wilfrid Laurier University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen D Perry, PhD, Wilfrid Laurier University

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

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.
April 1, 2014

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 1, 2015

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.
August 1, 2015

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).
May 28, 2014

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.
July 9, 2014

First Posted (Estimate)

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.
July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

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.
December 7, 2016

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.
December 6, 2016

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.
December 1, 2016

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.
  • HM_TCFP

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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