<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/NCT02215590</url>
  </required_header>
  <id_info>
    <org_study_id>2014-9</org_study_id>
    <nct_id>NCT02215590</nct_id>
  </id_info>
  <brief_title>Re-Step: Dynamic Balance Treatment of Gait for Acquired Brain Injury (ABI) Victims</brief_title>
  <official_title>Re-Step: a Computerized Dynamic Balance Treatment for Rehabilitation of Unassisted Gait in ABI Victims: a Prospective, Exploratory and Interventional Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Reuth Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Reuth Rehabilitation Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to:&#xD;
&#xD;
        1. Test the walking functionality of people following Acquired brain injury (ABI)&#xD;
&#xD;
        2. Suggesting a new treatment for their walking impairments&#xD;
&#xD;
        3. Follow-up of motor learning ability and balance after intervention within this&#xD;
           population&#xD;
&#xD;
      The investigators intend to target dynamic stability and gait after ABI, in a group of&#xD;
      individuals with ABI who have persistent balance and mobility deficits despite being able to&#xD;
      walk independently and having high scores on standard clinical balance measures.&#xD;
&#xD;
      Interventions: Training with Re-Step system shoes.&#xD;
&#xD;
      In this study there is no control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design:&#xD;
&#xD;
      Type of research: Prospective, exploratory, clinical, interventional trial&#xD;
&#xD;
      Specific objectives are:&#xD;
&#xD;
      To explore the efficacy of Re-step rehabilitation technology to improve dynamic balance in&#xD;
      the gait of people after Acquired Brain Injury (ABI).&#xD;
&#xD;
      The investigators suggest a new technology of intervention that will induce unexpected&#xD;
      changes of underfoot slopes, with Re-Step shoes, during walking and will force the central&#xD;
      nervous system (CNS) to react and solve walking problems in real-time.&#xD;
&#xD;
      The investigators propose that the new approach will have a significant motor function&#xD;
      improvement on balance in gait, transferred to real environmental settings and be retained&#xD;
      for long periods of time.&#xD;
&#xD;
      Research methods:&#xD;
&#xD;
      Subjects:&#xD;
&#xD;
      A total of 40 subjects of ABI victims will be studied in one treatment group-Re-Step shoes&#xD;
      walking training&#xD;
&#xD;
      Time flow protocol:&#xD;
&#xD;
      Participants will be approached using a database of hospitalized patients of Reuth&#xD;
      Rehabilitation Hospital (Tel-Aviv, Israel) and through a call for participation placed in a&#xD;
      newspaper.&#xD;
&#xD;
      Subjects will be recruited according to inclusion/exclusion criteria, after medical&#xD;
      examination and given consent of participation.&#xD;
&#xD;
      Tests and measures (see outcome measures) will be applied to measure changes:&#xD;
&#xD;
        -  T1 - before starting the intervention to form a baseline&#xD;
&#xD;
        -  T2 - after 20 sessions of intensive treatments 60 min each, 2 sessions a week.&#xD;
&#xD;
        -  T3 - 6 months after T2, a period of normal daily schedule of subjects, with no&#xD;
           interventions, to examine for retainment of training results.&#xD;
&#xD;
      The treatments will start in a week from T1; the T2 will be performed in a week after&#xD;
      training was completed; T3 will be performed 6 months (take or leave 2 weeks) after T2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Community Balance &amp; Mobility Scale (CB&amp;M); Change from base line after intervention is being assessed</measure>
    <time_frame>Measuring mobility ability and balance at base line and changes after intervention; and changes and rtainment of achievments 6 months of no intervention</time_frame>
    <description>CB&amp;M was designed to evaluate balance and mobility in patients who, although ambulatory, have balance impairments that reduce their full engagement in community living. 13 items of dynamic balance are graded 0-5 by a physiotherapist. The CB&amp;M is a reliable and valid clinical outcome measure for evaluating change in ability in the higher functioning ambulatory patients with TBI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>10 Meter walk Test (10MWT)</measure>
    <time_frame>Measuring at base line; change immediately after intervention, and changes and retainments of achievments after 6 months</time_frame>
    <description>Assesses walking speed in meters per second over a short duration. The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed (this distance is not included when determining speed). The distance covered is divided by the time it took the individual to walk that distance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>Recruitment stage</time_frame>
    <description>Widely used method for assessing cognitive mental status both in clinical practice and in research.&#xD;
It is a brief, standardized method to grade patients' cognitive mental status. It assesses orientation, attention, immediate and short-term recall, language, and the ability to follow simple verbal and written commands. It provides a total score that places the individual on a scale of cognitive function.&#xD;
The MoCA test has a high sensitivity for detecting cognitive dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fMRI functional magnetic Resonance Imaging; Change from base line after intervention is being assessed</measure>
    <time_frame>Base line brain activity; change after treatment; and change after 6 months with no interventions</time_frame>
    <description>Functional magnetic resonance imaging or functional MRI (fMRI) is a functional neuroimaging procedure using MRI technology that measures brain activity by detecting associated changes in blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Acquired Brain Injury</condition>
  <arm_group>
    <arm_group_label>Re-Step</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The system consists of a pair of special shoes which sole height and angles change in a specific given order, thereby facilitating motor learning and problem solving in real time.&#xD;
This unpredictable change will introduce a situation of necessary adaptation to keep balance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Re-Step</intervention_name>
    <description>Research Group:&#xD;
Each session begins with a warm-up exercise, muscle stretching, and strengthening exercises: duration 10 minutes.&#xD;
Afterwards, walking exercises for 40 minutes with Re-Step according to a program individually tailored and progressing with the training. Progress is shown by an increased range of tilting of the shoe and speed of changes, according to the individual ability of each patient.&#xD;
At the end of the session 10 min of cool-down exercises&#xD;
22 training sessions of 60 minutes each, twice a week.</description>
    <arm_group_label>Re-Step</arm_group_label>
    <other_name>Step of Mind's Re-Step System shoes</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least one year after the Acquired brain injury.&#xD;
&#xD;
          -  Age 18 to 80 years&#xD;
&#xD;
          -  Independent walking ability for at least 10 meters&#xD;
&#xD;
          -  Patients who permanently use medications that have not been changed during the past&#xD;
             month and with no further changes expected during the research&#xD;
&#xD;
          -  At least 19 points on the MoCA test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of degenerative neurological disability that is not secondary to the acquired&#xD;
             brain injury&#xD;
&#xD;
          -  Other disabilities such as - severe back pain, radical active lumbosacral radicular&#xD;
             pain, leg muscle pain, peripheral neuropathy, post-polio syndrome, rheumatic&#xD;
             illnesses, previous orthopedic disabilities preceding or at the time of the injury&#xD;
             that could affect the ability and pattern of walking, depression, and other neurotic&#xD;
             syndromes including post-traumatic depression and post-traumatic stress disorder&#xD;
             (PTSD) at a medium level or higher, chronic alcoholism and use of drugs.&#xD;
&#xD;
          -  Unstable state of health such as heart disease, respiratory insufficiency, peripheral&#xD;
             vascular disease, acquired brain injury that has impaired walking ability&#xD;
&#xD;
          -  Inability to persevere and cooperate in the series of tests and the follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simona Bar-Haim, PhD; PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Laboratory for Rehabilitation and Motor Control of Walking Faculty of Health Sciences at Ben-Gurion University of the Negev Israel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean-Jacques Vatine, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Reuth Rehabilitation Hospital Tel-Aviv Israel.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Reuth Rehabilitation Hospital</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>6772829</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postural balance</keyword>
  <keyword>Motor Learning and Motor Control</keyword>
  <keyword>Community integration</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Functional ambulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02215590
org study id: 2014-9
nct id: NCT02215590
lead sponsor: 
has dmc: Yes
The purpose of this study is to:

        1. Test the walking functionality of people following Acquired brain injury (ABI)

        2. Suggesting a new treatment for their walking impairments

        3. Follow-up of motor learning ability and balance after intervention within this
           population

      The investigators intend to target dynamic stability and gait after ABI, in a group of
      individuals with ABI who have persistent balance and mobility deficits despite being able to
      walk independently and having high scores on standard clinical balance measures.

      Interventions: Training with Re-Step system shoes.

      In this study there is no control group.
Study design:

      Type of research: Prospective, exploratory, clinical, interventional trial

      Specific objectives are:

      To explore the efficacy of Re-step rehabilitation technology to improve dynamic balance in
      the gait of people after Acquired Brain Injury (ABI).

      The investigators suggest a new technology of intervention that will induce unexpected
      changes of underfoot slopes, with Re-Step shoes, during walking and will force the central
      nervous system (CNS) to react and solve walking problems in real-time.

      The investigators propose that the new approach will have a significant motor function
      improvement on balance in gait, transferred to real environmental settings and be retained
      for long periods of time.

      Research methods:

      Subjects:

      A total of 40 subjects of ABI victims will be studied in one treatment group-Re-Step shoes
      walking training

      Time flow protocol:

      Participants will be approached using a database of hospitalized patients of Reuth
      Rehabilitation Hospital (Tel-Aviv, Israel) and through a call for participation placed in a
      newspaper.

      Subjects will be recruited according to inclusion/exclusion criteria, after medical
      examination and given consent of participation.

      Tests and measures (see outcome measures) will be applied to measure changes:

        -  T1 - before starting the intervention to form a baseline

        -  T2 - after 20 sessions of intensive treatments 60 min each, 2 sessions a week.

        -  T3 - 6 months after T2, a period of normal daily schedule of subjects, with no
           interventions, to examine for retainment of training results.

      The treatments will start in a week from T1; the T2 will be performed in a week after
      training was completed; T3 will be performed 6 months (take or leave 2 weeks) after T2.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Community Balance & Mobility Scale (CB&M); Change from base line after intervention is being assessed
time frame: Measuring mobility ability and balance at base line and changes after intervention; and changes and rtainment of achievments 6 months of no intervention
description: CB&M was designed to evaluate balance and mobility in patients who, although ambulatory, have balance impairments that reduce their full engagement in community living. 13 items of dynamic balance are graded 0-5 by a physiotherapist. The CB&M is a reliable and valid clinical outcome measure for evaluating change in ability in the higher functioning ambulatory patients with TBI.
measure: 10 Meter walk Test (10MWT)
time frame: Measuring at base line; change immediately after intervention, and changes and retainments of achievments after 6 months
description: Assesses walking speed in meters per second over a short duration. The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed (this distance is not included when determining speed). The distance covered is divided by the time it took the individual to walk that distance.
measure: Montreal Cognitive Assessment (MoCA)
time frame: Recruitment stage
description: Widely used method for assessing cognitive mental status both in clinical practice and in research.
It is a brief, standardized method to grade patients' cognitive mental status. It assesses orientation, attention, immediate and short-term recall, language, and the ability to follow simple verbal and written commands. It provides a total score that places the individual on a scale of cognitive function.
The MoCA test has a high sensitivity for detecting cognitive dysfunction.
measure: fMRI functional magnetic Resonance Imaging; Change from base line after intervention is being assessed
time frame: Base line brain activity; change after treatment; and change after 6 months with no interventions
description: Functional magnetic resonance imaging or functional MRI (fMRI) is a functional neuroimaging procedure using MRI technology that measures brain activity by detecting associated changes in blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases.
arm group label: Re-Step
arm group type: Experimental
description: The system consists of a pair of special shoes which sole height and angles change in a specific given order, thereby facilitating motor learning and problem solving in real time.
This unpredictable change will introduce a situation of necessary adaptation to keep balance.
intervention type: Device
intervention name: Re-Step
description: Research Group:
Each session begins with a warm-up exercise, muscle stretching, and strengthening exercises: duration 10 minutes.
Afterwards, walking exercises for 40 minutes with Re-Step according to a program individually tailored and progressing with the training. Progress is shown by an increased range of tilting of the shoe and speed of changes, according to the individual ability of each patient.
At the end of the session 10 min of cool-down exercises
22 training sessions of 60 minutes each, twice a week.
arm group label: Re-Step
other name: Step of Mind's Re-Step System shoes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Simona Bar-Haim, PhD; PT
role: Principal Investigator
affiliation: The Laboratory for Rehabilitation and Motor Control of Walking Faculty of Health Sciences at Ben-Gurion University of the Negev Israel
last name: Jean-Jacques Vatine, Dr.
role: Study Director
affiliation: Reuth Rehabilitation Hospital Tel-Aviv Israel.
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Brain Injuries