<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/NCT04455607</url>
  </required_header>
  <id_info>
    <org_study_id>Sor 396-16 CTIL</org_study_id>
    <nct_id>NCT04455607</nct_id>
  </id_info>
  <brief_title>Perturbation Training to Improve Balance Recovery of Old Adults</brief_title>
  <acronym>BalancING</acronym>
  <official_title>The Influence of a Perturbation Training on Balance Recovery of Old Adults - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soroka University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soroka University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Falls are major contributors for immobility and independency. Most falls in older adults&#xD;
      occur during walking after a sudden unexpected loss of balance. It was well-established that&#xD;
      balance can be improved by performance of a training program that provides perturbation&#xD;
      (unexpected perturbations of balance). The main aim of the current study is to investigate&#xD;
      the effects of two perturbation-training methods: 1) random perturbation training; vs. 2)&#xD;
      block (non-random) perturbation training. We also aim to explore brain area's (as measured by&#xD;
      MRI) that are related to balance function in older adults.&#xD;
&#xD;
      We hypothesize that response to an unexpected loss of balance is the balance responses will&#xD;
      be improved in both training methods, but more in the random training method. We also&#xD;
      hypothesize that brain function as seen in MRI will be improved in both training methods,&#xD;
      more in the random training method.&#xD;
&#xD;
      As far as we know, there is a lack of studies investigating the learning effect of random vs.&#xD;
      block non-random training on balance recovery responses while walking and exposure to&#xD;
      unexpected loss of balance and on brain function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Goals:&#xD;
&#xD;
        1. Determine the relationship between gait stability (as measured in the Lab) and brain&#xD;
           function (MRI) in 50 old (70 years old and over) and 10 young adults (20-40 years old)&#xD;
           that represent heathy brain.&#xD;
&#xD;
        2. To determine which of the training intervention methods (25 older adults that&#xD;
           participate in random training vs. 25 older adults that participate in block non-random&#xD;
           training) are more beneficial for balance recovery responses and for improved brain&#xD;
           function.&#xD;
&#xD;
      Methods: This study is a clinical investigation study. First stage - Individuals that show an&#xD;
      interest in participating in the study will be exposed to a brief interview before further&#xD;
      testing is performed to see if they fit the inclusion-exclusion criteria. Individuals who&#xD;
      pass the interview a screening, and physical examination and the additional questionnaires&#xD;
      and functional tests described below.&#xD;
&#xD;
      Second stage - Testing different motor learning paradigms for improving balance recovery&#xD;
      ability: A convenience sample of 60 healthy subjects (10 young's, 50 older adults) will be&#xD;
      recruited. After testing their clinical balance performance (Berg balance test, 6-minutes'&#xD;
      walk and get up and go) and cognitive function (MOCA), All testing will occur on a specific&#xD;
      motor-driven surface perturbation treadmill (BaMPer). The Gait protocol will include about&#xD;
      10-20 minutes of comfortable pace walking, than progressive unexpected surface perturbations&#xD;
      will be added. The same protocol will be performed with during standing condition. Subjects&#xD;
      will also walk on the treadmill without perturbations. The order of the different test&#xD;
      conditions will be randomized.&#xD;
&#xD;
      Outcome measures: The stepping threshold as measured by the distance of the platform&#xD;
      movements in centimeters will be measured. Quantitative parameters of the compensatory&#xD;
      stepping/ and motor ability (i.e., step reaction time, step time, step length), descriptive&#xD;
      parameters of the stepping strategy after perturbation&#xD;
&#xD;
      (i.e., arm responses, upper body responses, leg step threshold and fall threshold). In&#xD;
      addition, we will be testing the correlation between brain activity and anatomy using brain&#xD;
      imaging in 10 young and 50 older adults and correlate with balance/motor function.&#xD;
&#xD;
      The aims of this study are to determine the relationship between the different requirements&#xD;
      for gait stability (walking without perturbations, ability to overcome small perturbations,&#xD;
      ability to overcome larger perturbations and, largest recoverable perturbation during&#xD;
      walking) and brain function and anatomy. The research hypothesis: there is a correlation&#xD;
      between the age related atrophies in areas of the brain and functional capacity&#xD;
&#xD;
      Third stage - A Randomized control trial we will compare two perturbation motor learning&#xD;
      paradigms with different challenge level of the practice condition (i.e. blocked practice vs&#xD;
      random practice). According to motor learning theory we hypothesize that a) healthy older&#xD;
      adults will benefit more from random practice. The purpose of this stage is to investigate&#xD;
      the effects of task practice order (random vs blocked) on motor learning (i.e. responding to&#xD;
      perturbations during walking) in older adults. According to motor learning theory we&#xD;
      hypothesize that a) healthy older adults will benefit more from the random motor learning&#xD;
      approach as compared to using blocked practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The step recovery thresholds and brain imaging (MRI)</measure>
    <time_frame>60 minute</time_frame>
    <description>The stepping threshold as measured by the distance of the platform movements in centimeters will be measured. Quantitative parameters of the compensatory stepping/ and motor ability (i.e., step reaction time, step time, step length), descriptive parameters of the stepping strategy after perturbation (i.e., arm responses, upper body responses, leg step threshold and fall threshold). In addition we will be testing the correlation between brain activity using brain imaging in both to find whether improvement in motor function are correlated with brain function and anatomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postural stability</measure>
    <time_frame>10 minutes</time_frame>
    <description>participants will be instructed to stand upright on the force platform with the feet positioned as close as possible (heels and toes touching). A total of six 30-second trials will conduct for two visual conditions: eyes open and eyes closed. Balance measurements will be collected with a Kistler 9287 single force platform (Kistler Instrument Corp, Winterthur, Switzerland), which measures the time-varying displacement of the center of pressure (CoP) under the participant's feet. The force platform data will be sampled at a frequency of 100 Hz and stored on a hard disk for later processing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Voluntary step test</measure>
    <time_frame>6 minutes</time_frame>
    <description>subjects will be instructed to step as quickly as possible following a cue signal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance test</measure>
    <time_frame>10 minutes</time_frame>
    <description>The participant is scored on 14 balance tasks. Maximum score of 56 represents good balance. Higher scores indicate higher levels of balance function, while 45 or less indicates a high risk of falling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>kinematics of walking</measure>
    <time_frame>10 minutes</time_frame>
    <description>subjects will be instructed to walk on a treadmill. During the experiment we will measure by 3D motion analysis system gait kinematics during walking at their preferred speed for 2 minutes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Old Adults</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Random perturbation training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Block perturbation training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>perturbation training</intervention_name>
    <description>A Randomized control trial we will compare two perturbation motor learning paradigms with different challenge level of the practice condition (i.e. blocked practice vs random practice). According to motor learning theory we hypothesize that a) healthy older adults will benefit more from random practice. The purpose of this stage is to investigate the effects of task practice order (random vs blocked) on motor learning (i.e. responding to perturbations during walking) in older adults. According to motor learning theory we hypothesize that a) healthy older adults will benefit more from the random motor learning approach as compared to using blocked practice.</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 70 years and older (with the young age of 20-40)&#xD;
&#xD;
          2. able to walk independently (without utilities treadmill or stick);&#xD;
&#xD;
          3. Be asked to invent a medical certificate which allows participation in exercise that&#xD;
             requires walking twice a week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. suffering from ischaemic heart disease which limits exercise and COPD and blood&#xD;
             pressure is not controlled;&#xD;
&#xD;
          2. not suffering serious vision problems;&#xD;
&#xD;
          3. does not suffer from this problem: (a score of 24 or higher on MOCA);&#xD;
&#xD;
          4. a year after analyzing the type of hip replacement or knee or broken extremities;&#xD;
&#xD;
          5. Does not suffer any neurological diseases or stroke.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ilan Shelef, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Soroka University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Itshak Melzer, PhD</last_name>
    <phone>972-8-6477725</phone>
    <email>itzikm@bgu.ac.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Itshak Melzer, PhD</last_name>
    <phone>972-8-6477725</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ben-guion University of the Negev,</name>
      <address>
        <city>Beer-Sheva</city>
        <zip>84105</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Itsahk Melzer, PhD</last_name>
      <phone>972-8-6477727</phone>
      <email>itzikm@bgu.ac.il</email>
    </contact>
    <investigator>
      <last_name>Ronen Debi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center</name>
      <address>
        <city>Beer-Sheva</city>
        <zip>84105</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Itshak Melzer, PhD</last_name>
      <phone>972-8-6477727</phone>
      <email>itzikm@bgu.ac.il</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>SorokaUMC</name>
      <address>
        <city>Beer-Sheva</city>
        <zip>84105</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>itshak Melzer, PhD</last_name>
      <phone>972-8-6477727</phone>
      <email>itzikm@bgu.ac.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>December 6, 2020</last_update_submitted>
  <last_update_submitted_qc>December 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04455607
org study id: Sor 396-16 CTIL
nct id: NCT04455607
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Falls are major contributors for immobility and independency. Most falls in older adults
      occur during walking after a sudden unexpected loss of balance. It was well-established that
      balance can be improved by performance of a training program that provides perturbation
      (unexpected perturbations of balance). The main aim of the current study is to investigate
      the effects of two perturbation-training methods: 1) random perturbation training; vs. 2)
      block (non-random) perturbation training. We also aim to explore brain area's (as measured by
      MRI) that are related to balance function in older adults.

      We hypothesize that response to an unexpected loss of balance is the balance responses will
      be improved in both training methods, but more in the random training method. We also
      hypothesize that brain function as seen in MRI will be improved in both training methods,
      more in the random training method.

      As far as we know, there is a lack of studies investigating the learning effect of random vs.
      block non-random training on balance recovery responses while walking and exposure to
      unexpected loss of balance and on brain function.
Goals:

        1. Determine the relationship between gait stability (as measured in the Lab) and brain
           function (MRI) in 50 old (70 years old and over) and 10 young adults (20-40 years old)
           that represent heathy brain.

        2. To determine which of the training intervention methods (25 older adults that
           participate in random training vs. 25 older adults that participate in block non-random
           training) are more beneficial for balance recovery responses and for improved brain
           function.

      Methods: This study is a clinical investigation study. First stage - Individuals that show an
      interest in participating in the study will be exposed to a brief interview before further
      testing is performed to see if they fit the inclusion-exclusion criteria. Individuals who
      pass the interview a screening, and physical examination and the additional questionnaires
      and functional tests described below.

      Second stage - Testing different motor learning paradigms for improving balance recovery
      ability: A convenience sample of 60 healthy subjects (10 young's, 50 older adults) will be
      recruited. After testing their clinical balance performance (Berg balance test, 6-minutes'
      walk and get up and go) and cognitive function (MOCA), All testing will occur on a specific
      motor-driven surface perturbation treadmill (BaMPer). The Gait protocol will include about
      10-20 minutes of comfortable pace walking, than progressive unexpected surface perturbations
      will be added. The same protocol will be performed with during standing condition. Subjects
      will also walk on the treadmill without perturbations. The order of the different test
      conditions will be randomized.

      Outcome measures: The stepping threshold as measured by the distance of the platform
      movements in centimeters will be measured. Quantitative parameters of the compensatory
      stepping/ and motor ability (i.e., step reaction time, step time, step length), descriptive
      parameters of the stepping strategy after perturbation

      (i.e., arm responses, upper body responses, leg step threshold and fall threshold). In
      addition, we will be testing the correlation between brain activity and anatomy using brain
      imaging in 10 young and 50 older adults and correlate with balance/motor function.

      The aims of this study are to determine the relationship between the different requirements
      for gait stability (walking without perturbations, ability to overcome small perturbations,
      ability to overcome larger perturbations and, largest recoverable perturbation during
      walking) and brain function and anatomy. The research hypothesis: there is a correlation
      between the age related atrophies in areas of the brain and functional capacity

      Third stage - A Randomized control trial we will compare two perturbation motor learning
      paradigms with different challenge level of the practice condition (i.e. blocked practice vs
      random practice). According to motor learning theory we hypothesize that a) healthy older
      adults will benefit more from random practice. The purpose of this stage is to investigate
      the effects of task practice order (random vs blocked) on motor learning (i.e. responding to
      perturbations during walking) in older adults. According to motor learning theory we
      hypothesize that a) healthy older adults will benefit more from the random motor learning
      approach as compared to using blocked practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: The step recovery thresholds and brain imaging (MRI)
time frame: 60 minute
description: The stepping threshold as measured by the distance of the platform movements in centimeters will be measured. Quantitative parameters of the compensatory stepping/ and motor ability (i.e., step reaction time, step time, step length), descriptive parameters of the stepping strategy after perturbation (i.e., arm responses, upper body responses, leg step threshold and fall threshold). In addition we will be testing the correlation between brain activity using brain imaging in both to find whether improvement in motor function are correlated with brain function and anatomy.
measure: Postural stability
time frame: 10 minutes
description: participants will be instructed to stand upright on the force platform with the feet positioned as close as possible (heels and toes touching). A total of six 30-second trials will conduct for two visual conditions: eyes open and eyes closed. Balance measurements will be collected with a Kistler 9287 single force platform (Kistler Instrument Corp, Winterthur, Switzerland), which measures the time-varying displacement of the center of pressure (CoP) under the participant's feet. The force platform data will be sampled at a frequency of 100 Hz and stored on a hard disk for later processing.
measure: Voluntary step test
time frame: 6 minutes
description: subjects will be instructed to step as quickly as possible following a cue signal
measure: Berg Balance test
time frame: 10 minutes
description: The participant is scored on 14 balance tasks. Maximum score of 56 represents good balance. Higher scores indicate higher levels of balance function, while 45 or less indicates a high risk of falling.
measure: kinematics of walking
time frame: 10 minutes
description: subjects will be instructed to walk on a treadmill. During the experiment we will measure by 3D motion analysis system gait kinematics during walking at their preferred speed for 2 minutes.
arm group label: experimental group
arm group type: Experimental
description: Random perturbation training
arm group label: control group
arm group type: Active Comparator
description: Block perturbation training
intervention type: Behavioral
intervention name: perturbation training
description: A Randomized control trial we will compare two perturbation motor learning paradigms with different challenge level of the practice condition (i.e. blocked practice vs random practice). According to motor learning theory we hypothesize that a) healthy older adults will benefit more from random practice. The purpose of this stage is to investigate the effects of task practice order (random vs blocked) on motor learning (i.e. responding to perturbations during walking) in older adults. According to motor learning theory we hypothesize that a) healthy older adults will benefit more from the random motor learning approach as compared to using blocked practice.
arm group label: control group
arm group label: experimental group
criteria: 
gender: All
minimum age: 70 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ilan Shelef, MD
role: Study Chair
affiliation: Soroka University Medical Center
last name: Itshak Melzer, PhD
phone: 972-8-6477725
email: itzikm@bgu.ac.il
last name: Itshak Melzer, PhD
phone: 972-8-6477725
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor