<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02188524</url>
  </required_header>
  <id_info>
    <org_study_id>HM_TCFP</org_study_id>
    <nct_id>NCT02188524</nct_id>
  </id_info>
  <brief_title>The Effect of Training Older Adults in Tai Chi and Compensatory Stepping on Balance Control</brief_title>
  <official_title>The Effect of Training Older Adults in Tai Chi and Compensatory Stepping on Balance Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wilfrid Laurier University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wilfrid Laurier University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For the duration of 10 weeks, participants will be asked to maintain their current levels of&#xD;
      physical activity and to take part in three testing sessions over the course of 10 weeks.&#xD;
      Objective and subjective measurements will be obtained at (week 0), at midpoint (week 5) and&#xD;
      after the intervention terminates (week 10). The objective measurements will be taken by&#xD;
      inserting pressure sensors directly into the shoe and recording the centre of pressure.&#xD;
      Markers will be attached to the surface of the body on the shoulders, feet and belly button&#xD;
      and video recording will be used to assess the movement of the centre of mass. The first task&#xD;
      requires individuals to stand in one spot with their eyes open, and then eyes closed.&#xD;
      Secondly, standing in one place, upon an auditory cue, arms will be lifted to the sky as fast&#xD;
      as possible. Lastly, participants will walk around a set of chairs while music plays and when&#xD;
      the music stops, this is a cue to stop walking. The Timed-Up-and-Go test requires&#xD;
      participants to rise from a seated position, walk 3 meters, turn and return to their original&#xD;
      seated position. The Berg Balance Scale requires the completion of a 14 task sequence which&#xD;
      evaluates balance ability during seated, and various standing positions as well as&#xD;
      transitioning movements. The other measurements taken are collected via a questionnaire about&#xD;
      balance confidence level. Upon arrival, participants are required to report whether they have&#xD;
      experienced a fall since the last class attended and if yes, a follow-up questionnaire is&#xD;
      also required to gain information about the nature of the fall.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of my research is to explore the benefits of a 10 week Tai Chi and&#xD;
      compensatory stepping training program on balance control among older adults by examining&#xD;
      static and dynamic postural responses to perturbations before (0 weeks), at midpoint (5&#xD;
      weeks) and after the intervention (10 weeks). This Tai Chi and compensatory stepping program&#xD;
      will be compared to a control group that will not participate in any physical activity for 10&#xD;
      weeks, but will be offered the chance to partake in a fall prevention program after the 10&#xD;
      weeks of testing has been completed. The program will be administered twice weekly for thirty&#xD;
      minutes each by experienced instructors at a community location (Lab at WLU). The Tai&#xD;
      Chi/compensatory stepping group will engage in 50 minutes of Tai Chi exercise followed by 10&#xD;
      minutes of controlled manual perturbations administered for compensatory stepping training.&#xD;
      The control group will not be participating in the Tai Chi and compensatory stepping training&#xD;
      during the initial 10 weeks of testing, but will be offered the chance to participate in&#xD;
      either the SMART fall prevention program, or given other resources for participation in a&#xD;
      fall prevention exercise program. Testing for both groups will take place at baseline (week&#xD;
      0), midpoint (week 5) and post-intervention (week 10). We will be assessing balance control&#xD;
      by administering the Berg Balance Scale (attached), the Timed-Up-and-Go Test and tracking the&#xD;
      variability, minimum and maximum displacements of the centre of pressure (COP), centre of&#xD;
      mass (COM) and maximum and minimum displacement between the COM and COP as an indication of&#xD;
      instability. The Activities-Specific Balance Confidence Scale questionnaire (attached) will&#xD;
      also be administered as an indication of balance confidence. Tighter regulation of COP and&#xD;
      COM and as well as a small displacement between the 2 values indicates greater balance&#xD;
      control. COP, COM and COP/COM relationship will be measured during three balance tasks.&#xD;
      Participants will have pressure insoles directly inserted into their shoes, markers attached&#xD;
      with tape to record movement velocity and change in position. For testing, participants will&#xD;
      be required to complete 3 tasks. The first is made up of two parts that measure static&#xD;
      balance. Participants will stand in one place with their eyes open for 3 trials for 30&#xD;
      seconds each and then they will be asked to repeat the same standing with their eyes closed.&#xD;
      The second task is a measure of static balance in response to a self -perturbation, where&#xD;
      participants will raise their arms at a high velocity to the sky to offset balance in&#xD;
      response to an unexpected auditory cue. The third task will require participants to walk in a&#xD;
      circle around a set of chairs and perturb their balance by terminating gait upon an&#xD;
      unexpected auditory cue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Center of mass - Center of pressure difference</measure>
    <time_frame>0,5,10 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Accidental Falls</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No exercise program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>exercise program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Tai Chi and Compensatory Stepping</description>
    <arm_group_label>Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - age 65+&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  paralysis&#xD;
&#xD;
          -  epilepsy&#xD;
&#xD;
          -  cerebral palsy&#xD;
&#xD;
          -  multiple sclerosis&#xD;
&#xD;
          -  Parkinson's disease&#xD;
&#xD;
          -  stroke&#xD;
&#xD;
          -  any other neurological disorder&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  vision problem other than corrective glasses&#xD;
&#xD;
          -  cataract surgery&#xD;
&#xD;
          -  a balance or coordination problem&#xD;
&#xD;
          -  an inner ear disorder&#xD;
&#xD;
          -  hearing problems&#xD;
&#xD;
          -  constant ringing in your ears&#xD;
&#xD;
          -  ear surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen D Perry, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wilfrid Laurier University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Biomechanics Lab</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>May 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wilfrid Laurier University</investigator_affiliation>
    <investigator_full_name>Dr. Stephen Perry</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>balance, exercise, compensatory stepping, tai chi</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02188524
org study id: HM_TCFP
nct id: NCT02188524
lead sponsor: 
has dmc: No
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.
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.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Center of mass - Center of pressure difference
time frame: 0,5,10 weeks
arm group label: Control Group
arm group type: No Intervention
description: No exercise program
arm group label: Exercise Group
arm group type: Experimental
description: exercise program
intervention type: Other
intervention name: Exercise
description: Tai Chi and Compensatory Stepping
arm group label: Exercise Group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen D Perry, PhD
role: Principal Investigator
affiliation: Wilfrid Laurier University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Wilfrid Laurier University
investigator full name: Dr. Stephen Perry
investigator title: Professor