<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/NCT04505527</url>
  </required_header>
  <id_info>
    <org_study_id>448-16-FB</org_study_id>
    <secondary_id>P20GM109090</secondary_id>
    <nct_id>NCT04505527</nct_id>
  </id_info>
  <brief_title>Variability of Movement on an Altered Inertial Dynamics Task</brief_title>
  <official_title>Variability of Movement on an Altered Inertial Dynamics Task</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of General Medical Sciences (NIGMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nebraska</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>
      The overall goal of this research is to compare the effects of two different exercise&#xD;
      programs on gait function in older adults. The investigators want to determine if&#xD;
      participation in lateral stepping exercise program for six weeks will improve gait functions&#xD;
      compared to forward walking exercise program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of this research is to compare the effects of two different exercise&#xD;
      programs on gait function in older adults. It is expected that improved control of foot&#xD;
      placement in the lateral stepping task will transfer to improved control during typical&#xD;
      forward walking. Moreover, it is expected that lateral stepping gait training will have a&#xD;
      greater effect on recurrent fallers older adults than on the non-fallers older adults and&#xD;
      young adults. It is also expected that the above beneficial results will be retained in a&#xD;
      follow-up test six weeks after completion of the intervention and will result in improvements&#xD;
      in common clinical balance tests that are used to assess fall risk. Therefore, in the current&#xD;
      proposal, older adults aged 65 years of age and over are being asked to participate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2017</start_date>
  <completion_date type="Actual">May 5, 2021</completion_date>
  <primary_completion_date type="Actual">May 5, 2018</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>
    <intervention_model_description>Older adults will be screened and will be randomly assigned to three groups - (i) non-fallers, (ii) recurrent fallers - control group, and (iii) recurrent fallers - intervention group. A fourth group consisted of healthy young adults. This group will receive lateral stepping intervention and outcomes will be measured as a reference.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Step width variability</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>The standard deviation of step width. Step width was measured as the mediolateral distance between the locations of the sequential left and right heel strikes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Step length variability</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>The standard deviation of step length. Step length was measured as the anteroposterior distance between the locations of the sequential left and right heel strikes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Swing time variability</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>The standard deviation of swing time. Swing time was measured as the time elapse during the swing phase of a leg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stride time variability</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>The standard deviation of stride time. Stride time was measured as the time between 2 consecutive ipsilateral heel strikes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stance time variability</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>The standard deviation of stance time. Stance time was measured as the time elapse during the stance phase of a leg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed-Up-and-Go (TUG)</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>The Timed-Up-and-Go test is used to assess mobility in older adults. It measures the time to get up from chair, walk 3 m, turn around, walk back, and sit down</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berg Balance Test (BBS)</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>The Berg Balance Test (14 items, max score: 56) is used to measure the functional balance in older adults. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from &quot;0&quot; (lowest level of function) to &quot;4&quot; (highest level).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Walking speed</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>Self-selected forward walking and sideways walking speed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls Efficacy Scale-International (FES-I)</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>The Falls Efficacy Scale-International (FES-I) questionnaire (16 items, max score: 64) is used to assess confidence in the performance of activities relevant to daily life. Participants rate 16 individual activities on a scale from 1 (not at all concerned) to 4 (very concerned).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Brief Pain Inventory - short form (BPI)</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>The short form of Brief Pain Inventory score (BPI) (4 Pain severity items, max score: 40; 7 Pain interference items, max score: 70) is used to measure the impact of pain on daily functions. Higher score suggests higher pain intensity (severity), and/or higher impact of pain on functioning (interference).</description>
  </other_outcome>
  <other_outcome>
    <measure>Mini-Mental State Examination (MMSE)</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>The Mini-Mental State Examination (MMSE) (11 items, max score: 30) is used to measure cognitive impairment. It consists of 11 questions grouped into 7 cognitive tasks. A score of 30 suggests no presence of cognitive impairment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Geriatric Depression Scale - short form (GDS)</measure>
    <time_frame>Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention</time_frame>
    <description>The Geriatric Depression Scale - short form (GDS) (15 items, max score: 15) is used to measure self-rated depressive symptoms of depression. A score of 5 or more suggests depression.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Older Adults</condition>
  <condition>Fall Patients</condition>
  <arm_group>
    <arm_group_label>Recurrent fallers - control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this control arm, older adults will have a typical forward walking training that mirror the lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min forward walking. The participants can increase their pace at the start of each trial but may not decrease it at the next session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recurrent fallers - intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this experimental arm, older adults will have a lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min sideways walking across a 10 m walkway changing body direction at the ends, thus alternating lead and lag limbs. The participants can increase their pace at the start of each trial but may not decrease it at the next session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Older non-fallers intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this experimental arm, older adults will have a lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min sideways walking across a 10 m walkway changing body direction at the ends, thus alternating lead and lag limbs. The participants can increase their pace at the start of each trial but may not decrease it at the next session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Younger adult control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Outcome measures from a young healthy group will also be measured as a reference. Will be used to compare outcome measured between older and young adults. Young adults will have a lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min sideways walking across a 10 m walkway changing body direction at the ends, thus alternating lead and lag limbs. The participants can increase their pace at the start of each trial but may not decrease it at the next session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lateral stepping</intervention_name>
    <description>Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.</description>
    <arm_group_label>Older non-fallers intervention group</arm_group_label>
    <arm_group_label>Recurrent fallers - intervention group</arm_group_label>
    <arm_group_label>Younger adult control group</arm_group_label>
    <other_name>Sideways walking</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Forward walking</intervention_name>
    <description>Subjects will have a typical forward walking</description>
    <arm_group_label>Recurrent fallers - control group</arm_group_label>
    <other_name>Typical walking</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must&#xD;
&#xD;
          -  be aged between 19 and 35 for the young adult group&#xD;
&#xD;
          -  be over 65 years of age for the older adult groups&#xD;
&#xD;
          -  be independently residing in the community&#xD;
&#xD;
          -  be able to provide informed consent&#xD;
&#xD;
          -  be able to walk independently without an assistive device or 30 minutes in&#xD;
             three-minute sections interspersed with rest periods.&#xD;
&#xD;
        The older participants must either have sustained two or more falls in the past year (i.e.&#xD;
        Fallers) or not have sustained any falls in the past year (i.e. Non-Fallers).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological disorder or progressive neurologic condition - epilepsy, Alzheimer&#xD;
             disease and other dementias, stroke, multiple sclerosis, Parkinson's disease, brain&#xD;
             infections, brain tumors.&#xD;
&#xD;
          -  Movement disorder - ataxia, dystonia, Huntington's disease, myoclonus, Parkinson&#xD;
             disease, progressive supranuclear palsy, Wilson disease.&#xD;
&#xD;
          -  History of Cardiovascular events this includes any history of heart problems (such as&#xD;
             heart attack, chest pain, or conditions which affect the heart's muscles, valves, or&#xD;
             rhythm)&#xD;
&#xD;
          -  Current injury or moderate to severe pain affecting the lower limbs, pelvis, back,&#xD;
             trunk.&#xD;
&#xD;
          -  Surgery within the past 6 months.&#xD;
&#xD;
          -  Current participation in any other study that involves walking, balance, or training.&#xD;
&#xD;
        Medications will not prevent inclusion in the study however they will be recorded to enable&#xD;
        consideration in subsequent post-hoc analyses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Skiadopoulos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Associate</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicholas Stergiou, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assistant Dean</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Biomechanics Research Building</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68182</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nebraska</investigator_affiliation>
    <investigator_full_name>Aaron Likens</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>balance</keyword>
  <keyword>gait</keyword>
  <keyword>variability</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/NCT04505527
org study id: 448-16-FB
secondary id: P20GM109090
nct id: NCT04505527
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall goal of this research is to compare the effects of two different exercise
      programs on gait function in older adults. The investigators want to determine if
      participation in lateral stepping exercise program for six weeks will improve gait functions
      compared to forward walking exercise program.
The overall goal of this research is to compare the effects of two different exercise
      programs on gait function in older adults. It is expected that improved control of foot
      placement in the lateral stepping task will transfer to improved control during typical
      forward walking. Moreover, it is expected that lateral stepping gait training will have a
      greater effect on recurrent fallers older adults than on the non-fallers older adults and
      young adults. It is also expected that the above beneficial results will be retained in a
      follow-up test six weeks after completion of the intervention and will result in improvements
      in common clinical balance tests that are used to assess fall risk. Therefore, in the current
      proposal, older adults aged 65 years of age and over are being asked to participate.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Older adults will be screened and will be randomly assigned to three groups - (i) non-fallers, (ii) recurrent fallers - control group, and (iii) recurrent fallers - intervention group. A fourth group consisted of healthy young adults. This group will receive lateral stepping intervention and outcomes will be measured as a reference.
primary purpose: Prevention
masking: None (Open Label)
measure: Step width variability
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: The standard deviation of step width. Step width was measured as the mediolateral distance between the locations of the sequential left and right heel strikes
measure: Step length variability
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: The standard deviation of step length. Step length was measured as the anteroposterior distance between the locations of the sequential left and right heel strikes.
measure: Swing time variability
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: The standard deviation of swing time. Swing time was measured as the time elapse during the swing phase of a leg.
measure: Stride time variability
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: The standard deviation of stride time. Stride time was measured as the time between 2 consecutive ipsilateral heel strikes.
measure: Stance time variability
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: The standard deviation of stance time. Stance time was measured as the time elapse during the stance phase of a leg.
measure: Timed-Up-and-Go (TUG)
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: The Timed-Up-and-Go test is used to assess mobility in older adults. It measures the time to get up from chair, walk 3 m, turn around, walk back, and sit down
measure: Berg Balance Test (BBS)
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: The Berg Balance Test (14 items, max score: 56) is used to measure the functional balance in older adults. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from "0" (lowest level of function) to "4" (highest level).
measure: Walking speed
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: Self-selected forward walking and sideways walking speed
measure: Falls Efficacy Scale-International (FES-I)
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: The Falls Efficacy Scale-International (FES-I) questionnaire (16 items, max score: 64) is used to assess confidence in the performance of activities relevant to daily life. Participants rate 16 individual activities on a scale from 1 (not at all concerned) to 4 (very concerned).
measure: Brief Pain Inventory - short form (BPI)
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: The short form of Brief Pain Inventory score (BPI) (4 Pain severity items, max score: 40; 7 Pain interference items, max score: 70) is used to measure the impact of pain on daily functions. Higher score suggests higher pain intensity (severity), and/or higher impact of pain on functioning (interference).
measure: Mini-Mental State Examination (MMSE)
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: The Mini-Mental State Examination (MMSE) (11 items, max score: 30) is used to measure cognitive impairment. It consists of 11 questions grouped into 7 cognitive tasks. A score of 30 suggests no presence of cognitive impairment.
measure: Geriatric Depression Scale - short form (GDS)
time frame: Baseline and Post-Intervention: immediate, and 6 weeks after the completion of the intervention
description: The Geriatric Depression Scale - short form (GDS) (15 items, max score: 15) is used to measure self-rated depressive symptoms of depression. A score of 5 or more suggests depression.
arm group label: Recurrent fallers - control group
arm group type: Active Comparator
description: In this control arm, older adults will have a typical forward walking training that mirror the lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min forward walking. The participants can increase their pace at the start of each trial but may not decrease it at the next session.
arm group label: Recurrent fallers - intervention group
arm group type: Experimental
description: In this experimental arm, older adults will have a lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min sideways walking across a 10 m walkway changing body direction at the ends, thus alternating lead and lag limbs. The participants can increase their pace at the start of each trial but may not decrease it at the next session.
arm group label: Older non-fallers intervention group
arm group type: Experimental
description: In this experimental arm, older adults will have a lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min sideways walking across a 10 m walkway changing body direction at the ends, thus alternating lead and lag limbs. The participants can increase their pace at the start of each trial but may not decrease it at the next session.
arm group label: Younger adult control group
arm group type: Active Comparator
description: Outcome measures from a young healthy group will also be measured as a reference. Will be used to compare outcome measured between older and young adults. Young adults will have a lateral stepping intervention: 3 days/week for 6 weeks, resulting in a total of eighteen sessions. Each session consists of six trials of 3 min sideways walking across a 10 m walkway changing body direction at the ends, thus alternating lead and lag limbs. The participants can increase their pace at the start of each trial but may not decrease it at the next session.
intervention type: Behavioral
intervention name: Lateral stepping
description: Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.
arm group label: Older non-fallers intervention group
arm group label: Recurrent fallers - intervention group
arm group label: Younger adult control group
other name: Sideways walking
intervention type: Behavioral
intervention name: Forward walking
description: Subjects will have a typical forward walking
arm group label: Recurrent fallers - control group
other name: Typical walking
criteria: 
gender: All
minimum age: 19 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas Skiadopoulos, PhD
role: Principal Investigator
affiliation: Research Associate
last name: Nicholas Stergiou, PhD
role: Study Director
affiliation: Assistant Dean
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nebraska
investigator full name: Aaron Likens
investigator title: Principal Investigator