<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/NCT03776201</url>
  </required_header>
  <id_info>
    <org_study_id>A18-0033</org_study_id>
    <secondary_id>1R15AG053866-01A1</secondary_id>
    <nct_id>NCT03776201</nct_id>
  </id_info>
  <brief_title>Merging Attentional Focus and Balance Training to Reduce Fall Risk in Older Adults</brief_title>
  <official_title>Merging Attentional Focus and Balance Training to Reduce Fall Risk in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Greensboro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Greensboro</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Approximately 15 million older adults fall every year in the United States and fall&#xD;
      prevention programs have only been moderately successful in arresting fall rates. This&#xD;
      proposal uses motor learning principles derived from the attentional focus literature to&#xD;
      determine whether training someone where to focus their attention during a balance task&#xD;
      enhances balance control and reduces fall risk. Older adults (N=90) who are classified as&#xD;
      fallers (one or more falls in the past 12 months) will be recruited. A series of balance&#xD;
      control, clinical metrics of fall risk, and patient-reported outcomes will be assessed prior,&#xD;
      during, and after a 12-week intervention to examine changes in performance and fall risk. The&#xD;
      12-week intervention will emphasize directing the participants' attention either internally&#xD;
      or externally during a series of balance tasks. Empirical evidence and our preliminary data&#xD;
      leads us to hypothesize that an external focus of attention training will positively&#xD;
      influence balance control. This will be the first study to will examine balance control&#xD;
      changes over 12-week balance intervention using an attentional focus paradigm and we will&#xD;
      relate the balance control changes to clinical metrics that indicate fall risk and&#xD;
      patient-reported outcomes. Further, our proposal includes a novel model of entropy in&#xD;
      postural sway, a metric that has been proposed to relate to balance ability, to help explain&#xD;
      the hypothesized enhancement in balance. Thus, this proposal will merge motor learning&#xD;
      principles with a 12-week balance intervention to determine if fall risk is reduced in older&#xD;
      adults. Specific Aim 1 compares balance performance within each trial/session throughout the&#xD;
      12 weeks of balance training to evaluate whether the attentional focus groups (external vs.&#xD;
      internal) differ in their motor learning trajectory with respect to the balance task.&#xD;
      Specific Aim 2 compares the motor ability outcome measures that relate to fall-risk between&#xD;
      the groups (external focus, internal focus, or control) before, during, and after the 12-week&#xD;
      balance intervention. Specific Aim 3 compares the patient-reported outcome measures of fear&#xD;
      of falling, functional health and well-being, and fear of injury from movement between the&#xD;
      groups (external focus, internal focus, or control) before, during, and after the 12-week&#xD;
      balance intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Falls due to poor balance are common and costly in older adults. Unfortunately, traditional&#xD;
      balance interventions show mixed results in reducing falls. Balance is controlled by a&#xD;
      complex system that depends on a host of cognitive functions, including attention. While&#xD;
      attention has different meanings in different research areas, this proposal will examine&#xD;
      attention defined as a performer's conscious perception of information for a task, which can&#xD;
      be focused internally or externally. An internal focus of attention is directed at the&#xD;
      performer's own body movements, while an external focus is directed at the effects a&#xD;
      particular movement has on the environment. Fall prevention interventions typically emphasize&#xD;
      an internal focus of attention. However, mounting evidence from laboratory settings indicates&#xD;
      that an external focus of attention improves balance control. For example, participants in&#xD;
      one study were asked to balance on a stabilometer, which is an unstable device that swings&#xD;
      forward or backward when someone is out of balance. Participants were asked to focus on&#xD;
      keeping their feet level (i.e., an internal focus) or keeping the surface of the stabilometer&#xD;
      level (i.e., an external focus). When the participants adopted an external focus, their&#xD;
      balance was enhanced. That is, they had fewer deviations from their starting position (i.e.,&#xD;
      less variability in their motion). Follow-up research also showed that participants were able&#xD;
      to respond faster to their change in body position during a balance task when they adopted an&#xD;
      external focus. Both of these characteristics would be beneficial for an older adult&#xD;
      population with a history of falls.&#xD;
&#xD;
      The theoretical explanation of these findings is the constrained-action hypothesis, which&#xD;
      suggests that an internal focus of attention constrains the system in a way that does not&#xD;
      allow it to find an optimal solution. For example, instructions that ask a participant to&#xD;
      focus internally by keeping their feet level may constrain other parts of the body and&#xD;
      actually diminish balance control. In contrast, instructions that ask a participant to focus&#xD;
      externally by keeping a balance apparatus level allow the body to find the optimal way to&#xD;
      perform the task. This small change in instruction has been repeatedly shown to significantly&#xD;
      enhance performance. Thus, emphasizing an external focus of attention may be critical to the&#xD;
      optimization of strategies designed to improve balance and reduce fall risk in older adults.&#xD;
      This approach does not require a re-tooling of all clinical practice, just a modification of&#xD;
      current delivery, making the cost-benefit ratio of the approach appealing to clinical&#xD;
      practitioners and administrators. The goal of this proposed study, therefore, is to extend&#xD;
      this line of research to determine the efficacy of using an external focus of attention to&#xD;
      enhance balance control and decrease fall risk in older adults.&#xD;
&#xD;
      To show proof-of-concept, we conducted 2 preliminary studies. The 1st preliminary study&#xD;
      showed that older adults who adopted an external focus of attention during a balance task had&#xD;
      greater postural control complexity, which is typically interpreted as a more adaptable and&#xD;
      less fall-prone behavior. The 2nd preliminary study showed that an external focus of&#xD;
      attention increases the time-in-balance for older adults standing on a wobble board. By&#xD;
      altering the attentional focus, our data show that the external focus instructions lead to&#xD;
      more stable postural control. This is consistent with the plethora of literature showing the&#xD;
      positive effect of adopting an external focus of attention on motor control performance.&#xD;
      These preliminary results give us confidence that a 12-week balance intervention that&#xD;
      emphasizes an external focus of attention will be superior to a similar intervention that&#xD;
      utilizes an internal focus of attention (i.e., what is used in traditional balance&#xD;
      interventions). Balance control, clinical metrics of fall risk, and patient-reported outcomes&#xD;
      of functional ability will be recorded before, during, and after a 12 week balance training&#xD;
      intervention in a cohort of 90 older adults with a history of falls. There are three specific&#xD;
      aims for this proposal:&#xD;
&#xD;
      SPECIFIC AIM 1: Compare balance performance within each trial/session to evaluate whether the&#xD;
      attentional focus groups (external vs. internal) differ in their motor learning trajectory&#xD;
      with respect to the balance task.&#xD;
&#xD;
      Hypothesis 1: The external focus group will exhibit a faster rate of motor learning toward&#xD;
      stable balance.&#xD;
&#xD;
      SPECIFIC AIM 2: Compare the motor ability outcome measures that relate to fall-risk between&#xD;
      the groups (external focus, internal focus, or control) before, during, and after the 12 week&#xD;
      balance intervention.&#xD;
&#xD;
      Hypothesis 2a: The external focus group will exhibit a greater reduction in fall-risk during&#xD;
      mid- and post-testing relative to the internal focus and control groups.&#xD;
&#xD;
      Hypothesis 2b: Sensory information (vision, vestibular, and somatosensory scores) and&#xD;
      attention will be related to fall risk, but mediated through entropy of postural sway.&#xD;
&#xD;
      SPECIFIC AIM 3: Compare the patient-reported outcome measures of fear of falling, functional&#xD;
      health and well-being, and fear of injury from movement between the groups (external focus,&#xD;
      internal focus, or control) before, during, and after the 12 week balance intervention.&#xD;
&#xD;
      Hypothesis 3: The external focus group will have a significantly lower fear of falling,&#xD;
      enhanced functional health and well-being, and lower fear of injury from movement during mid-&#xD;
      and post-testing relative to the internal focus and control groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the BTracks measurement</measure>
    <time_frame>Weeks 0, 6, 12, 13, 16, 20</time_frame>
    <description>The average measurement of the center of pressure displacement during three 20-second trials with eyes closed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Functional Gait Assessment</measure>
    <time_frame>Weeks 0, 6, 12, 13, 16, 20</time_frame>
    <description>Assesses postural stability during walking tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Timed Up and Go</measure>
    <time_frame>Weeks 0, 6, 12, 13, 16, 20</time_frame>
    <description>Assesses a person's mobility and requires both static and dynamic balance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Berg Balance Test</measure>
    <time_frame>Weeks 0, 6, 12, 13, 16, 20</time_frame>
    <description>Assesses the static standing balance and subsequent fall risk</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Activities Balance Confidence Scale short version</measure>
    <time_frame>Weeks 0, 6, 12, 13, 16, 20</time_frame>
    <description>Assesses the Fear of Falling. The scale is from 0-100% for the overall scores. The scores from each of the 16 questions (which range from 0-100%) are summed and then divided by 16 to get the overall score. A high score equates to greater function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Short Form 36</measure>
    <time_frame>Weeks 0, 6, 12, 13, 16, 20</time_frame>
    <description>The SF-36 is a measure of health status. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Tampa Scale of Kinesiophobia</measure>
    <time_frame>Weeks 0, 6, 12, 13, 16, 20</time_frame>
    <description>The Tampa Scale of Kinesiophobia measures the fear of injury from movement on a range of 17-68, with high scores indicating high fear of movement related injury. A cutoff score of 37 indicates increased fear of injury from movement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the XSens - Time in Balance - Anterior Posterior</measure>
    <time_frame>Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome.</time_frame>
    <description>Duration in which the wobble board is +/- 3 deg of a neutral position (0 deg) in the anterior-posterior direction for 30 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the XSens - Time in Balance - Medial Lateral</measure>
    <time_frame>Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome.</time_frame>
    <description>Duration in which the wobble board is +/- 3 deg of a neutral position (0 deg) in the medial-lateral direction for 30 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the XSens - Mean Power Frequency - Anterior Posterior</measure>
    <time_frame>Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome.</time_frame>
    <description>Mean power frequency of the wobble board in the anterior-posterior direction for 30 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the XSens - Mean Power Frequency - Medial Lateral</measure>
    <time_frame>Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome.</time_frame>
    <description>Mean power frequency of the wobble board in the medial-lateral direction for 30 seconds</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Accidental Fall</condition>
  <arm_group>
    <arm_group_label>Internal Focus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The internal focus group will receive 20 minutes of balance training 2 times per week. All training sessions will include a 5-minute walking warm-up, a 20-minute balance training program, and a 5-minute walking cool-down. The balance training will use a 30&quot; wobble board with five bases ranging from 1&quot; (easy) to 3&quot; (very difficult). 20 trials of balance practice for 30-second intervals with 30-second breaks in between trials will be used every day. The Internal Focus group will be reminded to focus their attention internally via the prompt &quot;keep your feet as level as possible&quot; prior to each balance trial. To monitor whether the experimental groups are focusing as asked and to what extent, a compliance check that has been used in similar attentional focus literature will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>External Focus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The external focus group will receive 20 minutes of balance training 2 times per week. All training sessions will include a 5-minute walking warm-up, a 20-minute balance training program, and a 5-minute walking cool-down. The balance training will use a 30&quot; wobble board with five bases ranging from 1&quot; (easy) to 3&quot; (very difficult). 20 trials of balance practice for 30-second intervals with 30-second breaks in between trials will be used every day. The external focus group will be reminded to focus their attention externally via the prompt &quot;please keep the board as level as possible&quot; prior to each balance trial. To monitor whether the experimental groups are focusing as asked and to what extent, a compliance check that has been used in similar attentional focus literature will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will not receive any balance training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balance Training</intervention_name>
    <description>We expect that a balance training intervention that utilizes an external focus of attention will lead to the adoption of balance strategies that are protective against falls. The mechanism for this behavioral change will be identified using a Dynamical Systems Theory framework (i.e., entropy) to quantify postural sway characteristics before, during and after the training. We will determine whether the balance intervention utilizing an external focus of attention will lead to positive benefits through the three specific aims.</description>
    <arm_group_label>External Focus</arm_group_label>
    <arm_group_label>Internal Focus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older adults (N=90) who are classified as fallers (≥ 1 fall in the last 12 months)&#xD;
             will be recruited&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Younger than 65 or older than 90 years old&#xD;
&#xD;
               -  Failure to receive medical clearance from their physician to participate in the&#xD;
                  study and confirming that their patient has fallen at least once within the last&#xD;
                  12 months&#xD;
&#xD;
               -  Inability to walk independently for at least 10 consecutive minutes&#xD;
&#xD;
               -  Score in the &quot;impaired&quot; range on the Mini-Mental State Examination, adjusted for&#xD;
                  age and education level [60].&#xD;
&#xD;
               -  A diagnosis of a neurological disorder that requires medication&#xD;
&#xD;
               -  A visual impairment of 20/70 or worse&#xD;
&#xD;
               -  A body mass index of ≥ 30&#xD;
&#xD;
               -  Any acute medical problems, including musculoskeletal based impairments, that&#xD;
                  lead to pain or discomfort during standing or walking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Louisa D Raisbeck, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Greensboro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNCG Motor Behavior</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03776201
org study id: A18-0033
secondary id: 1R15AG053866-01A1
nct id: NCT03776201
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Approximately 15 million older adults fall every year in the United States and fall
      prevention programs have only been moderately successful in arresting fall rates. This
      proposal uses motor learning principles derived from the attentional focus literature to
      determine whether training someone where to focus their attention during a balance task
      enhances balance control and reduces fall risk. Older adults (N=90) who are classified as
      fallers (one or more falls in the past 12 months) will be recruited. A series of balance
      control, clinical metrics of fall risk, and patient-reported outcomes will be assessed prior,
      during, and after a 12-week intervention to examine changes in performance and fall risk. The
      12-week intervention will emphasize directing the participants' attention either internally
      or externally during a series of balance tasks. Empirical evidence and our preliminary data
      leads us to hypothesize that an external focus of attention training will positively
      influence balance control. This will be the first study to will examine balance control
      changes over 12-week balance intervention using an attentional focus paradigm and we will
      relate the balance control changes to clinical metrics that indicate fall risk and
      patient-reported outcomes. Further, our proposal includes a novel model of entropy in
      postural sway, a metric that has been proposed to relate to balance ability, to help explain
      the hypothesized enhancement in balance. Thus, this proposal will merge motor learning
      principles with a 12-week balance intervention to determine if fall risk is reduced in older
      adults. Specific Aim 1 compares balance performance within each trial/session throughout the
      12 weeks of balance training to evaluate whether the attentional focus groups (external vs.
      internal) differ in their motor learning trajectory with respect to the balance task.
      Specific Aim 2 compares the motor ability outcome measures that relate to fall-risk between
      the groups (external focus, internal focus, or control) before, during, and after the 12-week
      balance intervention. Specific Aim 3 compares the patient-reported outcome measures of fear
      of falling, functional health and well-being, and fear of injury from movement between the
      groups (external focus, internal focus, or control) before, during, and after the 12-week
      balance intervention.
Falls due to poor balance are common and costly in older adults. Unfortunately, traditional
      balance interventions show mixed results in reducing falls. Balance is controlled by a
      complex system that depends on a host of cognitive functions, including attention. While
      attention has different meanings in different research areas, this proposal will examine
      attention defined as a performer's conscious perception of information for a task, which can
      be focused internally or externally. An internal focus of attention is directed at the
      performer's own body movements, while an external focus is directed at the effects a
      particular movement has on the environment. Fall prevention interventions typically emphasize
      an internal focus of attention. However, mounting evidence from laboratory settings indicates
      that an external focus of attention improves balance control. For example, participants in
      one study were asked to balance on a stabilometer, which is an unstable device that swings
      forward or backward when someone is out of balance. Participants were asked to focus on
      keeping their feet level (i.e., an internal focus) or keeping the surface of the stabilometer
      level (i.e., an external focus). When the participants adopted an external focus, their
      balance was enhanced. That is, they had fewer deviations from their starting position (i.e.,
      less variability in their motion). Follow-up research also showed that participants were able
      to respond faster to their change in body position during a balance task when they adopted an
      external focus. Both of these characteristics would be beneficial for an older adult
      population with a history of falls.

      The theoretical explanation of these findings is the constrained-action hypothesis, which
      suggests that an internal focus of attention constrains the system in a way that does not
      allow it to find an optimal solution. For example, instructions that ask a participant to
      focus internally by keeping their feet level may constrain other parts of the body and
      actually diminish balance control. In contrast, instructions that ask a participant to focus
      externally by keeping a balance apparatus level allow the body to find the optimal way to
      perform the task. This small change in instruction has been repeatedly shown to significantly
      enhance performance. Thus, emphasizing an external focus of attention may be critical to the
      optimization of strategies designed to improve balance and reduce fall risk in older adults.
      This approach does not require a re-tooling of all clinical practice, just a modification of
      current delivery, making the cost-benefit ratio of the approach appealing to clinical
      practitioners and administrators. The goal of this proposed study, therefore, is to extend
      this line of research to determine the efficacy of using an external focus of attention to
      enhance balance control and decrease fall risk in older adults.

      To show proof-of-concept, we conducted 2 preliminary studies. The 1st preliminary study
      showed that older adults who adopted an external focus of attention during a balance task had
      greater postural control complexity, which is typically interpreted as a more adaptable and
      less fall-prone behavior. The 2nd preliminary study showed that an external focus of
      attention increases the time-in-balance for older adults standing on a wobble board. By
      altering the attentional focus, our data show that the external focus instructions lead to
      more stable postural control. This is consistent with the plethora of literature showing the
      positive effect of adopting an external focus of attention on motor control performance.
      These preliminary results give us confidence that a 12-week balance intervention that
      emphasizes an external focus of attention will be superior to a similar intervention that
      utilizes an internal focus of attention (i.e., what is used in traditional balance
      interventions). Balance control, clinical metrics of fall risk, and patient-reported outcomes
      of functional ability will be recorded before, during, and after a 12 week balance training
      intervention in a cohort of 90 older adults with a history of falls. There are three specific
      aims for this proposal:

      SPECIFIC AIM 1: Compare balance performance within each trial/session to evaluate whether the
      attentional focus groups (external vs. internal) differ in their motor learning trajectory
      with respect to the balance task.

      Hypothesis 1: The external focus group will exhibit a faster rate of motor learning toward
      stable balance.

      SPECIFIC AIM 2: Compare the motor ability outcome measures that relate to fall-risk between
      the groups (external focus, internal focus, or control) before, during, and after the 12 week
      balance intervention.

      Hypothesis 2a: The external focus group will exhibit a greater reduction in fall-risk during
      mid- and post-testing relative to the internal focus and control groups.

      Hypothesis 2b: Sensory information (vision, vestibular, and somatosensory scores) and
      attention will be related to fall risk, but mediated through entropy of postural sway.

      SPECIFIC AIM 3: Compare the patient-reported outcome measures of fear of falling, functional
      health and well-being, and fear of injury from movement between the groups (external focus,
      internal focus, or control) before, during, and after the 12 week balance intervention.

      Hypothesis 3: The external focus group will have a significantly lower fear of falling,
      enhanced functional health and well-being, and lower fear of injury from movement during mid-
      and post-testing relative to the internal focus and control groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in the BTracks measurement
time frame: Weeks 0, 6, 12, 13, 16, 20
description: The average measurement of the center of pressure displacement during three 20-second trials with eyes closed
measure: Change in the Functional Gait Assessment
time frame: Weeks 0, 6, 12, 13, 16, 20
description: Assesses postural stability during walking tasks
measure: Change in the Timed Up and Go
time frame: Weeks 0, 6, 12, 13, 16, 20
description: Assesses a person's mobility and requires both static and dynamic balance.
measure: Change in the Berg Balance Test
time frame: Weeks 0, 6, 12, 13, 16, 20
description: Assesses the static standing balance and subsequent fall risk
measure: Change in the Activities Balance Confidence Scale short version
time frame: Weeks 0, 6, 12, 13, 16, 20
description: Assesses the Fear of Falling. The scale is from 0-100% for the overall scores. The scores from each of the 16 questions (which range from 0-100%) are summed and then divided by 16 to get the overall score. A high score equates to greater function.
measure: Change in the Short Form 36
time frame: Weeks 0, 6, 12, 13, 16, 20
description: The SF-36 is a measure of health status. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.
measure: Change in the Tampa Scale of Kinesiophobia
time frame: Weeks 0, 6, 12, 13, 16, 20
description: The Tampa Scale of Kinesiophobia measures the fear of injury from movement on a range of 17-68, with high scores indicating high fear of movement related injury. A cutoff score of 37 indicates increased fear of injury from movement
measure: Change in the XSens - Time in Balance - Anterior Posterior
time frame: Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome.
description: Duration in which the wobble board is +/- 3 deg of a neutral position (0 deg) in the anterior-posterior direction for 30 seconds
measure: Change in the XSens - Time in Balance - Medial Lateral
time frame: Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome.
description: Duration in which the wobble board is +/- 3 deg of a neutral position (0 deg) in the medial-lateral direction for 30 seconds
measure: Change in the XSens - Mean Power Frequency - Anterior Posterior
time frame: Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome.
description: Mean power frequency of the wobble board in the anterior-posterior direction for 30 seconds
measure: Change in the XSens - Mean Power Frequency - Medial Lateral
time frame: Assessed at the end of each training session, which is provided 2 times per week for 12 weeks. Thus, this variable is assessed a total of 24 times. After the 24 sessions, the timeframe is complete for this outcome.
description: Mean power frequency of the wobble board in the medial-lateral direction for 30 seconds
arm group label: Internal Focus
arm group type: Experimental
description: The internal focus group will receive 20 minutes of balance training 2 times per week. All training sessions will include a 5-minute walking warm-up, a 20-minute balance training program, and a 5-minute walking cool-down. The balance training will use a 30" wobble board with five bases ranging from 1" (easy) to 3" (very difficult). 20 trials of balance practice for 30-second intervals with 30-second breaks in between trials will be used every day. The Internal Focus group will be reminded to focus their attention internally via the prompt "keep your feet as level as possible" prior to each balance trial. To monitor whether the experimental groups are focusing as asked and to what extent, a compliance check that has been used in similar attentional focus literature will be used.
arm group label: External Focus
arm group type: Experimental
description: The external focus group will receive 20 minutes of balance training 2 times per week. All training sessions will include a 5-minute walking warm-up, a 20-minute balance training program, and a 5-minute walking cool-down. The balance training will use a 30" wobble board with five bases ranging from 1" (easy) to 3" (very difficult). 20 trials of balance practice for 30-second intervals with 30-second breaks in between trials will be used every day. The external focus group will be reminded to focus their attention externally via the prompt "please keep the board as level as possible" prior to each balance trial. To monitor whether the experimental groups are focusing as asked and to what extent, a compliance check that has been used in similar attentional focus literature will be used.
arm group label: Control
arm group type: No Intervention
description: The control group will not receive any balance training
intervention type: Other
intervention name: Balance Training
description: We expect that a balance training intervention that utilizes an external focus of attention will lead to the adoption of balance strategies that are protective against falls. The mechanism for this behavioral change will be identified using a Dynamical Systems Theory framework (i.e., entropy) to quantify postural sway characteristics before, during and after the training. We will determine whether the balance intervention utilizing an external focus of attention will lead to positive benefits through the three specific aims.
arm group label: External Focus
arm group label: Internal Focus
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: No
last name: Louisa D Raisbeck, PhD
role: Principal Investigator
affiliation: University of North Carolina, Greensboro
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No