<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/NCT04473885</url>
  </required_header>
  <id_info>
    <org_study_id>YM109047F</org_study_id>
    <nct_id>NCT04473885</nct_id>
  </id_info>
  <brief_title>Effects of Perturbation-based Balance Training on Postural Control and Cortical Modulation in Elderly With Fall Risk</brief_title>
  <official_title>Effects of Multi-directional Perturbation-based Balance Training on Postural Control and Cortical Modulation in Elderly With Fall Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Yang Ming University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-blinded randomized controlled trial with pre- and post- measurements. Forty&#xD;
      community-dwelling elderly (age&gt; 65 y/o) with fall risk (defined as functional reach&#xD;
      test≦25.4 cm) will be recruited and randomly assigned to experimental group or control group&#xD;
      (n=20 for each group). Participants in the experimental group will receive the balance&#xD;
      training under perturbation on Balance SystemTM SD, including limits of stability training,&#xD;
      maze control training, random control training. The intervention is 40 min/session, 3&#xD;
      sessions/week for 6 weeks. Participants in the control group will remain their regular&#xD;
      activity without additional training. The primary outcomes include the limit of stability&#xD;
      (LOS) of posture control by Balance Master® and brain modulation by Event-Related&#xD;
      Desynchronization (ERD) collected by electroencephalogram (EEG). Secondary outcomes include&#xD;
      the sensory organization test (SOT), Berg balance scale (BBS), and falls efficacy scale&#xD;
      International (FES-I).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Falling is one of the common factors affecting the health in older people. It&#xD;
      would cause severe consequences and result in decreasing mobility and independent activity of&#xD;
      daily living. According to previous study, balance impairment is the frequent factor for fall&#xD;
      in elderly. To maintain balance, reactive postural control ability is the key element from&#xD;
      falling. It is suggested that perturbation-based balance training can improve reactive&#xD;
      balance performance. However, few studies focus on multi-direction perturbation to mimic the&#xD;
      perturbation experienced in daily living. Furthermore, the related cortical activity changes&#xD;
      after perturbation-based balance training is not known.&#xD;
&#xD;
      Purpose: The purpose of this study is to explore the effects of multi-directional&#xD;
      perturbation-based balance training on posture control and brain modulation in elderly with&#xD;
      fall risk.&#xD;
&#xD;
      Methods: This is a single-blinded randomized controlled trial with pre- and post-&#xD;
      measurements. Forty community-dwelling elderly (age&gt; 65 y/o) with fall risk (defined as&#xD;
      functional reach test≦25.4 cm) will be recruited and randomly assigned to experimental group&#xD;
      or control group (n=20 for each group). Participants in the experimental group will receive&#xD;
      the balance training under perturbation on Balance SystemTM SD, including limits of stability&#xD;
      training, maze control training, random control training. The intervention is 40 min/session,&#xD;
      3 sessions/week for 6 weeks. Participants in the control group will remain their regular&#xD;
      activity without additional training. The primary outcomes include the limit of stability&#xD;
      (LOS) of posture control by Balance Master® and brain modulation by Event-Related&#xD;
      Desynchronization (ERD) collected by electroencephalogram (EEG). Secondary outcomes include&#xD;
      the sensory organization test (SOT), Berg balance scale (BBS), and falls efficacy scale&#xD;
      International (FES-I). Independent t test and Chi-square test are used for baseline&#xD;
      characteristic analysis. All outcomes will be analyzed by repeated measures two-way ANOVA&#xD;
      with Tukey post hoc test for within-group and between-group comparisons. Statistical&#xD;
      significance is set at p&lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2020</start_date>
  <completion_date type="Actual">May 17, 2021</completion_date>
  <primary_completion_date type="Actual">May 17, 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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Limits of Stability</measure>
    <time_frame>15 minutes</time_frame>
    <description>Assessing posture control by Balance Master®</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cortical modulation</measure>
    <time_frame>1 hour</time_frame>
    <description>Assessing brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensory Organization Test</measure>
    <time_frame>15 minutes</time_frame>
    <description>Assessing by Balance Master®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>15 minutes</time_frame>
    <description>Total score is ranged 0-56, higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls Efficacy Scale International</measure>
    <time_frame>15 minutes</time_frame>
    <description>Total score is ranged 16-64, higher scores mean a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Old Age; Debility</condition>
  <condition>Fall</condition>
  <arm_group>
    <arm_group_label>Perturbation-based balance training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group will remain their regular activity without additional training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Perturbation-based balance training</intervention_name>
    <description>Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks.</description>
    <arm_group_label>Perturbation-based balance training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 65 y/o community-dwelling elderly with fall risk (Functional reach test ≦25.4&#xD;
             cm).&#xD;
&#xD;
          -  Mini-Mental State Examination score (MMSE) ≧ 24.&#xD;
&#xD;
          -  Able to walk independently without assistance at least 10 meters.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With any neurological, mental or cognitive disorders, and orthopedic, pulmonary or&#xD;
             cardiac problems that could restrict or preclude their participation in exercise.&#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>Ray-Yau Wang</last_name>
    <role>Study Chair</role>
    <affiliation>National Yang Ming Chiao Tung University, Taiwan, R.O.C.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Yang Ming Chiao Tung University</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>November 12, 2021</last_update_submitted>
  <last_update_submitted_qc>November 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Perturbation-based balance training</keyword>
  <keyword>Postural control</keyword>
  <keyword>Cortical modulation</keyword>
  <keyword>Elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <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/NCT04473885
org study id: YM109047F
nct id: NCT04473885
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a single-blinded randomized controlled trial with pre- and post- measurements. Forty
      community-dwelling elderly (age> 65 y/o) with fall risk (defined as functional reach
      test≦25.4 cm) will be recruited and randomly assigned to experimental group or control group
      (n=20 for each group). Participants in the experimental group will receive the balance
      training under perturbation on Balance SystemTM SD, including limits of stability training,
      maze control training, random control training. The intervention is 40 min/session, 3
      sessions/week for 6 weeks. Participants in the control group will remain their regular
      activity without additional training. The primary outcomes include the limit of stability
      (LOS) of posture control by Balance Master® and brain modulation by Event-Related
      Desynchronization (ERD) collected by electroencephalogram (EEG). Secondary outcomes include
      the sensory organization test (SOT), Berg balance scale (BBS), and falls efficacy scale
      International (FES-I).
Background: Falling is one of the common factors affecting the health in older people. It
      would cause severe consequences and result in decreasing mobility and independent activity of
      daily living. According to previous study, balance impairment is the frequent factor for fall
      in elderly. To maintain balance, reactive postural control ability is the key element from
      falling. It is suggested that perturbation-based balance training can improve reactive
      balance performance. However, few studies focus on multi-direction perturbation to mimic the
      perturbation experienced in daily living. Furthermore, the related cortical activity changes
      after perturbation-based balance training is not known.

      Purpose: The purpose of this study is to explore the effects of multi-directional
      perturbation-based balance training on posture control and brain modulation in elderly with
      fall risk.

      Methods: This is a single-blinded randomized controlled trial with pre- and post-
      measurements. Forty community-dwelling elderly (age> 65 y/o) with fall risk (defined as
      functional reach test≦25.4 cm) will be recruited and randomly assigned to experimental group
      or control group (n=20 for each group). Participants in the experimental group will receive
      the balance training under perturbation on Balance SystemTM SD, including limits of stability
      training, maze control training, random control training. The intervention is 40 min/session,
      3 sessions/week for 6 weeks. Participants in the control group will remain their regular
      activity without additional training. The primary outcomes include the limit of stability
      (LOS) of posture control by Balance Master® and brain modulation by Event-Related
      Desynchronization (ERD) collected by electroencephalogram (EEG). Secondary outcomes include
      the sensory organization test (SOT), Berg balance scale (BBS), and falls efficacy scale
      International (FES-I). Independent t test and Chi-square test are used for baseline
      characteristic analysis. All outcomes will be analyzed by repeated measures two-way ANOVA
      with Tukey post hoc test for within-group and between-group comparisons. Statistical
      significance is set at p<0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Limits of Stability
time frame: 15 minutes
description: Assessing posture control by Balance Master®
measure: Cortical modulation
time frame: 1 hour
description: Assessing brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG)
measure: Sensory Organization Test
time frame: 15 minutes
description: Assessing by Balance Master®
measure: Berg Balance Scale
time frame: 15 minutes
description: Total score is ranged 0-56, higher scores mean a better outcome.
measure: Falls Efficacy Scale International
time frame: 15 minutes
description: Total score is ranged 16-64, higher scores mean a better outcome.
arm group label: Perturbation-based balance training group
arm group type: Experimental
description: Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks.
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group will remain their regular activity without additional training.
intervention type: Other
intervention name: Perturbation-based balance training
description: Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks.
arm group label: Perturbation-based balance training group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ray-Yau Wang
role: Study Chair
affiliation: National Yang Ming Chiao Tung University, Taiwan, R.O.C.
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Frailty
sharing ipd: No