<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/NCT03757026</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-FY2019-17</org_study_id>
    <secondary_id>18IPA34170316</secondary_id>
    <nct_id>NCT03757026</nct_id>
  </id_info>
  <brief_title>Comparison of Three Balance Training Protocols for Individuals Post Stroke</brief_title>
  <official_title>Balance Training Post Stroke: Intense Harnessed Multidirectional Training as Compared to Reactive and Conventional Protocols</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cleveland State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cleveland State University</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 purpose of this study is to compare conventional balance training to reactive training&#xD;
      and to a novel, high intensity, harnessed training program. This study examines the impact of&#xD;
      these interventions on fall risk and on a range of important aspects of balance including&#xD;
      overall mobility, quality of life, and health. Participants will be 60-69 adults who had a&#xD;
      stroke more than 6 months ago and who ambulate independently. Each participant will complete&#xD;
      14 sessions consisting of 4 (2 pre-, 2 post-) testing sessions and 10 intervention sessions.&#xD;
      The pre and post testing will be the same and will consist of clinical and survey based&#xD;
      balance and quality of life assessments and treadmill based perturbed gait testing.&#xD;
&#xD;
      The pretest will be sessions 1 and 2 will be followed by 10 intervention sessions. There will&#xD;
      be 3 treatment groups: a conventional balance training group (PT), a reactive slip training&#xD;
      group (Slip), and a multidirectional harness group (MHG). Participants will be randomly&#xD;
      assigned to a group following screening and consent.&#xD;
&#xD;
      The conventional balance training group (PT) will receive 10 sessions of individualized&#xD;
      standard of care physical therapy with the goal of improving balance and mobility. The only&#xD;
      instructions to the PT are that the focus of the course of care should be on &quot;balance and&#xD;
      mobility&quot; and that there should be 10 sessions.&#xD;
&#xD;
      The reactive slip training group (Slip) will complete a standing slip session using the&#xD;
      current protocol of scaling slip distance and force to each individual and modulating the&#xD;
      slip intensity across the session based on subject responses. The remaining nine intervention&#xD;
      sessions will consist of accompanied walking for up to 45 minutes. Participants will walk at&#xD;
      a comfortable pace while accompanied by a researcher.&#xD;
&#xD;
      The multidirectional harness group (MHG) will use a harness that allows movement in all&#xD;
      directions, playing selected Kinect™ active video games with varied balance demands, on&#xD;
      multiple balance training surfaces (e.g., rocker board, foam, slider platform). Participants&#xD;
      will wear the fall-arresting harness for all game play. Motion data will be collected during&#xD;
      Sessions 2, 6, and 10.&#xD;
&#xD;
      For all groups, two-post-test sessions will follow the intervention sessions and will be the&#xD;
      same as the two-pretest session. The final session will also include reviewing the&#xD;
      participants' falls diaries and setting up procedures for contacting participants weekly or&#xD;
      biweekly about falls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study compares conventional balance training to a reactive slip protocol and novel, high&#xD;
      intensity, harnessed balance training using video gaming. It examines the impact of these&#xD;
      three interventions on fall risk and on aspects of balance including overall mobility,&#xD;
      quality of life and community participation. The study includes 60-69 adults who had a stroke&#xD;
      more than 6 months ago and who walk independently. Participants will complete 14 sessions: 4&#xD;
      sessions (2 pre-, 2 post-) of testing and 10 intervention sessions. There will be one to two&#xD;
      sessions per week depending on scheduling and participant preference.&#xD;
&#xD;
      The first session will begin with screening and the consent process after which participants&#xD;
      will be randomly assigned to one of the following three groups of 20-22 participants each:&#xD;
      conventional balance training (PT), reactive slip training (Slip), and multi-directional&#xD;
      harnessed gaming training (MHG). The first individual entering the study will be randomly&#xD;
      assigned to one of the three groups, the next person will be randomly assigned to one of the&#xD;
      two remaining groups, and the third person will be placed in the remaining group. This&#xD;
      process will be repeated with the next group of three individuals entering the study, and so&#xD;
      on. Approximately midway through the study, researchers will assess group mix for impairment&#xD;
      severity levels and adjust if necessary. All 14 sessions are outlined below including&#xD;
      descriptions of testing and intervention procedures.&#xD;
&#xD;
      During session one, the screening, consent and randomization process will be followed by the&#xD;
      clinical testing, falls history and falls diary initiation, then scheduling of subsequent&#xD;
      visits. Participants will be questioned as to any falls within the last 12 months, and if any&#xD;
      - how long ago for each fall and the circumstances of and any injuries from the fall as they&#xD;
      recall them. The falls diary will be explained to the participants and participants will be&#xD;
      asked to keep it during the weeks of the 14 sessions and for 6 months afterwards. The&#xD;
      stability (RPS) scale will be explained to the participants and remaining clinical testing&#xD;
      will be administered including the Mini-Balance Evaluation Systems Test (miniBEST). The&#xD;
      limits of stability testing (LOS), including the reactive perturbation testing portion of the&#xD;
      miniBEST will be performed with motion capture. If time, participant scheduling, and&#xD;
      participant tolerance for activity permit, the LOS testing will be done at the second&#xD;
      pre-test session because this will allow motion marker placement for one session rather than&#xD;
      two, saving the participant time. If timing or participant activity tolerance do not allow,&#xD;
      the LOS testing will be performed, with motion capture, at the first pre-test session.&#xD;
&#xD;
      The second session will continue the pre-test portion of the protocol with treadmill&#xD;
      perturbation testing and LOS testing. All participants will be supported in a fall-arresting&#xD;
      harness for all treadmill perturbation testing. First, the treadmill will be used to measure&#xD;
      the participant's normal then fast walking speeds. For perturbations, the treadmill will be&#xD;
      run at the participant's determined normal walking speed. It will randomly accelerate at&#xD;
      mid-stance of the hemiparetic foot, then return to its usual speed. The participant will be&#xD;
      asked to try to maintain his/her balance and continue walking as before, but that if the&#xD;
      participant needs to stop, the investigator will halt the treadmill and provide a rest break.&#xD;
      After each perturbation, the participant will be asked to score it on the RPS scale.&#xD;
      Throughout all of the treadmill perturbation testing force, motion, and load cell data will&#xD;
      be recorded and vital signs will be monitored consistent with Physical Therapy and exercise&#xD;
      standards.&#xD;
&#xD;
      There will be up to 18 perturbations. The initial perturbation intensity will be based on the&#xD;
      participant's miniBEST scores and normalized to that individual's maximum gait speed. Each&#xD;
      subsequent perturbation intensity will be determined based on the participant's response to&#xD;
      the previous perturbations: three consecutive falls (&gt;30% of participant's body weight as&#xD;
      measured by load cell) leads to a decrease in perturbation intensity; three consecutive&#xD;
      recoveries (&lt;5%of participant's body weight as measured by load cell) leads to an increase in&#xD;
      perturbation intensity; and if the three previous perturbations were mixed (some combination&#xD;
      of falls, recoveries, and harness assists) the perturbation will be unchanged. The outcome of&#xD;
      each trial (fall, recovery, or harness assist) will be recorded.&#xD;
&#xD;
      After pretesting, 10 intervention sessions will begin based on group assignment, as described&#xD;
      above. The conventional balance training group (PT) will receive individualized standard of&#xD;
      care physical therapy with the goal of improving balance and mobility during sessions 3&#xD;
      through 12. This will be completed by an experienced community physical therapist who will be&#xD;
      blinded to the other groups' activities and to all pre-testing results. The first visit will&#xD;
      have approximately 60 minutes allotted for the initial evaluation and limited treatment while&#xD;
      the remaining 9 sessions will consist of 45 minutes of PT treatment. The only instructions to&#xD;
      the PT are that the focus of the course of care should be on &quot;balance and mobility&quot; and that&#xD;
      there should be 10 sessions total. The investigators will be blinded to the specifics of the&#xD;
      individual treatments provided by the PT(s).&#xD;
&#xD;
      The reactive slip training group (Slip) will complete one standing slip session using the&#xD;
      current protocol of scaling slip distance and force to each individual and modulating the&#xD;
      slip intensity across the session based on participant responses. To match intervention time&#xD;
      to the other two groups, the remaining 9 sessions will involve 45 minutes of supervised&#xD;
      walking with vital sign and distance monitoring, and rest as necessary.&#xD;
&#xD;
      All participants will use a full-body, fall-arresting harness throughout all slip testing.&#xD;
      All participants will be informed that during the experimental procedures the Slip Trainer&#xD;
      platform, on which they are standing, may move suddenly and unexpectedly under their feet.&#xD;
      The participants will be asked to react as naturally as possible to the perturbation. The&#xD;
      participants will also be informed that if they are unable to catch themselves, the full-body&#xD;
      safety harness they will be wearing will prevent a fall from occurring. Participants will be&#xD;
      reminded that they may request a rest break at any time. Participants will be guarded by an&#xD;
      investigator (both licensed Physical Therapists) or by a Student PT supervised by an&#xD;
      investigator.&#xD;
&#xD;
      The Slip Trainer is a low platform on rollers which allow only anterior-posterior&#xD;
      (forward-backward) slips, not side to side. Participants will stand quietly on the trainer&#xD;
      and slips will be induced by the (randomly timed and unannounced) release of weights from a&#xD;
      designated height, causing the weights to fall and the platform to be pulled backward or&#xD;
      forward approximately 15 - 30 centimeters. The amount of weight released will range from&#xD;
      15-40% of the participant's body weight. Up to 17 slips will be induced. The participants&#xD;
      will self-rate their stability during the slip with the RPS immediately after each slip&#xD;
      recovery. Motion, load cell and outcomes data will be collected throughout slip testing.&#xD;
      Initial perturbation intensity (percent body weight and slip distance) will be based on the&#xD;
      participant's miniBEST score and each subsequent perturbation intensity will be determined&#xD;
      based on the participant's response to the previous perturbations. If this algorithm leads to&#xD;
      the perturbations being reduced below 5% and 5 cm or above 40% and 30 cm, the trials will be&#xD;
      stopped.&#xD;
&#xD;
      The remaining nine intervention sessions will consist of accompanied walking for up to 45&#xD;
      minutes. Participants will come to Cleveland State University and will walk at a comfortable&#xD;
      pace while accompanied by a researcher in the areas in or adjacent to the Health Sciences&#xD;
      spaces. Researchers will monitor the participants' vital signs as indicated and in the manner&#xD;
      consistent with standard PT/exercise practice. Participants may request rest breaks as&#xD;
      needed. The researcher will record the distances walked, the rests taken, and the vital signs&#xD;
      as taken.&#xD;
&#xD;
      The multidirectional harness group (MHG) will use a harness with the Open Area Support System&#xD;
      (OASUS) multidirectional harness framework and play selected Kinect™ active video games with&#xD;
      varied balance demands, while standing on multiple balance training surfaces (e.g., solid&#xD;
      floor, rocker board, foam, slider platform). Participants will wear the fall-arresting&#xD;
      harness in the OASUS system for all game play. This harness allows participants to move&#xD;
      freely in any direction except it limits their vertical descent to a pre-set height. This&#xD;
      will be adjusted to a height that allows the participants to touch the floor or support&#xD;
      surface with only their feet when fully suspended in the harness in any direction; no other&#xD;
      body part will be able to reach the ground. This will be re-adjusted each time the&#xD;
      participant changes the playing surface.&#xD;
&#xD;
      Initial game and training surface combinations as well as subsequent difficulty levels and&#xD;
      training conditions will be chosen using a progression algorithm in conjunction with the Rate&#xD;
      of Perceived Stability (RPS). Motion data will be collected during gaming for Sessions 2, 6,&#xD;
      and 10. RPS scores will be collected during and immediately after all gaming sessions.&#xD;
      Participants are able to use rest breaks and will be monitored throughout all sessions&#xD;
      consistent with standard physical therapy/exercise practice. At the first session of MHG,&#xD;
      participants will be introduced to each game and given time to practice playing that game&#xD;
      until they feel comfortable with each game. All participants will progress with the&#xD;
      prescribed sequence of games and surfaces, progressing based on their rating of the previous&#xD;
      three bouts of play.&#xD;
&#xD;
      Two post-test sessions will follow the 10 intervention sessions. These will be equivalent to&#xD;
      the two-pretest session above with the treadmill testing at session 13, LOS testing at either&#xD;
      session 13 or 14, and the remaining clinical testing and follow up at session 14. All&#xD;
      participants will be reminded of previous protocols/instructions completed in their pretest&#xD;
      sessions. The 14th and final session will also include reviewing the participants' falls&#xD;
      diaries and setting up procedures for contacting participants weekly or biweekly about falls.&#xD;
      The participant will have a chance to ask any questions about the overall study and the&#xD;
      payment forms will be signed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Activities Specific Balance Confidence Scale (ABC) at study completion</measure>
    <time_frame>Through study completion, on average three months.</time_frame>
    <description>Indicates how self-confident the participants are not to lose their balance or become unsteady during specific activities like: walk around house, walk up and down stairs, pick up a slipper from the floor, etc. (Rating self-confidence from 0-100% on each of 16 items; then total score divided by 16 to give an overall self-confidence level, with 100% being fully confident on all 16 activities listed)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Mini Balance Evaluation Systems Test (MiniBEST) at study completion</measure>
    <time_frame>Through study completion, on average three months.</time_frame>
    <description>It aims to target and identify different balance control systems to identify balance deficits. The MiniBEST test is a 14-item test scored on a 3-level ordinal scale. Sections include anticipatory, reactive postural control, sensory orientation, and dynamic balance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Mobility life space scale (MLSS) at study completion</measure>
    <time_frame>Through study completion, on average three months.</time_frame>
    <description>Questions for life-space mobility refers to 1) the level of the spatial area (bedroom, home, outside home, neighborhood, town, and beyond town) that an individual purposely moves through in daily life; 2) to the frequency of movement within a specific time in each area; and 3) the need for assistance with that movement. Scores range from 0 for someone who remains only the bedroom to up to 120 for someone who travels daily and independently out of his/her immediate community.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline anterior, posterior, and lateral (to right and to left sides) limits of stability (LOS) scores at study completion</measure>
    <time_frame>Through study completion, on average three months.</time_frame>
    <description>Standing limits of stability (LOS) are tested by having the participant lean as far as he/she can to the front, back, and each side, twice, without stepping or needing to reach out for support. Motion data will be used to calculate the participant's center of mass (COM) and base of support (BOS) during this test. Then, the percent of the distance the participant can move his/her COM towards the edge of his/her BOS will be calculated in each of the four directions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Treadmill perturbation stability scores at study completion</measure>
    <time_frame>Through study completion, on average three months.</time_frame>
    <description>Participants will walk on the treadmill to determine normal and maximum gait speed. Walking at normal speed, at a random time at about mid-stance of the hemiparetic lower extremity, the treadmill will accelerate suddenly then return to its previous speed. Initial perturbation intensity will be based on the participant's miniBEST scores and normalized to that individual's maximum gait speed. Each subsequent perturbation intensity will be based on the participant's response to previous perturbations: 3 consecutive falls (&gt;30% of participant's body weight as measured by load cell) leads to a decrease in perturbation intensity; 3 consecutive recoveries (&lt;5%) leads to an increase in perturbation intensity; and if the 3 previous perturbations were mixed (combination of falls, recoveries, and harness assists) the perturbation will be unchanged. Each response will be recorded as a recovery, harness assist, or fall (recovery &lt;5%, harness assist 5%-30%, or fall &gt;30% of body weight).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Falls Diary at 6 months post study completion</measure>
    <time_frame>Through 6 months post study completion, on average a total of 9 months including study duration plus 6 months post study follow-up.</time_frame>
    <description>During the pre-testing sessions, participants will be asked verbally to describe their recall of falls they have experienced in the past 12 months, to be recorded by a researcher, and to keep a log of falls over the course of the study and follow-up period of 6 months (to be collected monthly after end of study by phone call).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Fugl Meyer Lower Extremity Sensory and Movement testing (FM LE) at study completion</measure>
    <time_frame>Through study completion, on average three months.</time_frame>
    <description>Evaluates and measures recovery in post-stroke hemiplegic patients. This outcome measure assesses sensorimotor function through the lower extremity. Items are scored on a 3-point ordinal scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Monofilament sensory testing (5.07 monofilament testing of foot and ankle) at study completion</measure>
    <time_frame>Through study completion, on average three months.</time_frame>
    <description>Using 5.07 monofilament, test the bottom and top of the foot below in locations pictured, including the medial and lateral malleolus and the anterior ankle at the mid-position between the two malleoli. While holding the handle, push the monofilament at a 90-degree angle against the skin until the monofilament bows. Hold for 1.5 seconds. Record with a check mark (√) if sensation intact and an X to denote no sensation at that point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Five times sit-to-stand test (5XSTS) at study completion</measure>
    <time_frame>Through study completion, on average three months.</time_frame>
    <description>Patient sits with arms folded across chest and with back against the chair. With patients who have had a stroke, it is permissible to have the impaired arm at the side or in a sling.They must stand fully between repetitions of the test and not to touch the back of the chair during each repetition. They will stand up full 5 times. Documentation of speed and assist level (CGA, supervision, Mod I, or I) will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Stroke Impact Scale (SIS) at study completion</measure>
    <time_frame>Through study completion, on average three months.</time_frame>
    <description>The Stroke Impact Scale (SIS) is a questionnaire that evaluates how a stroke has impacted the participant's health and life. The SIS has eight sections measuring self-perceived strength, memory and thinking, emotion, communication, activities of daily living, mobility, hand use, and work/leisure participation. There are multiple questions in each section, with each question rated from 1 to 5 in terms of activity difficulty, activity frequency, or strength. Summary scores are generated for each of the 8 sections. The scoring uses a transformed scale [(actual raw score - lowest possible raw score) /possible raw score range] x 100) and some items must be reverse scored. Scores range from 0-100% for each section with 100% indicating the highest level of function. There is also a final ninth section rating percent overall self-perceived recovery from the stroke with 100% being fully recovered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Berg Balance Scale (BBS) at study completion</measure>
    <time_frame>Through study completion, on average three months.</time_frame>
    <description>The BBS measures balance ability (static and dynamic) among older adults. The BBS is a qualitative measure that assesses balance through performing functional activities. Each item is scored on a 5-point scale, ranging from 0 to 4, zero indicating the lowest level of function and 4 the highest level of function.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Fall</condition>
  <condition>Risk Reduction</condition>
  <condition>Stroke</condition>
  <condition>Balance</condition>
  <arm_group>
    <arm_group_label>Conventional Physical Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20-22 participants randomly assigned to receive 10 sessions of balance training. Conventional balance training group (PT) will receive individualized standard of care physical therapy with the goal of improving balance and mobility during sessions 3 through 12. The only instructions to the PT are that the focus of the course of care should be on &quot;balance and mobility&quot; and that there should be 10 sessions total. The first visit will include an initial evaluation and limited treatment. While the remaining 9 sessions will consist of 45 minutes of PT treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Slip training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20-22 participants randomly assigned to 1 session of slip training and 9 sessions of accompanied walking. Reactive slip training group (Slip) will complete a standing slip session using the current protocol of scaling slip distance and force to each individual and modulating the slip intensity across the session based on subject responses. Initial perturbation intensity (percent body weight and slip distance) will be based on the participant's miniBEST score and each subsequent perturbation intensity will be determined based on their response to the previous perturbations. The remaining nine intervention sessions will consist of accompanied walking for up to 45 minutes. Participants will walk at a comfortable pace while accompanied by a researcher around Cleveland State.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Harnessed gaming</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20-22 participants randomly assigned to 10 sessions of harnessed gaming. Multidirectional harness group (MHG) will use a harness with the multidirectional OASUS frame and play selected Kinect™ active video games with varied balance demands, while standing on multiple balance training surfaces (e.g., solid floor, rocker board, foam, slider platform). Participants will wear the fall-arresting harness in the OASUS system for all game play. Motion data will be collected during gaming for Sessions 2, 6, and 10. Each game/surface will be played for about 5 to 6 minutes for 4 game/surface conditions per session. All participants will progress with the prescribed sequence of games and surfaces, progressing based on their rating of the previous three bouts of play.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Physical Therapy</intervention_name>
    <description>20-22 participants randomly assigned to receive 10 sessions of balance training. Conventional balance training group (PT) will receive individualized standard of care physical therapy with the goal of improving balance and mobility during sessions 3 through 12. The only instructions to the PT are that the focus of the course of care should be on &quot;balance and mobility&quot; and that there should be 10 sessions total. The first visit will include an initial evaluation and limited treatment. While the remaining 9 sessions will consist of 45 minutes of PT treatment.</description>
    <arm_group_label>Conventional Physical Therapy</arm_group_label>
    <other_name>Balance training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Slip Training</intervention_name>
    <description>20-22 participants randomly assigned to 1 session of slip training and 9 sessions of accompanied walking. Reactive slip training group (Slip) will complete a standing slip session using the current protocol of scaling slip distance and force to each individual and modulating the slip intensity across the session based on subject responses. Initial perturbation intensity (percent body weight and slip distance) will be based on the participant's miniBEST score and each subsequent perturbation intensity will be determined based on their response to the previous perturbations. The remaining nine interventional sessions will consist of accompanied walking for up to 45 minutes. Participants will walk at a comfortable pace while accompanied by a researcher around Cleveland State.</description>
    <arm_group_label>Slip training</arm_group_label>
    <other_name>Reactive slip training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Harnessed gaming</intervention_name>
    <description>20-22 participants randomly assigned to 10 sessions of harnessed gaming. Multidirectional harness group (MHG) will use a harness with the multidirectional OASUS frame and play selected Kinect™ active video games with varied balance demands, while standing on multiple balance training surfaces (e.g., solid floor, rocker board, foam, slider platform). Participants will wear the fall-arresting harness in the OASUS system for all game play. Motion data will be collected during gaming for Sessions 2, 6, and 10. Each game/surface will be played for about 5 to 6 minutes for 4 game/surface conditions per session. All participants will progress with the prescribed sequence of games and surfaces, progressing based on their rating of the previous three bouts of play.</description>
    <arm_group_label>Harnessed gaming</arm_group_label>
    <other_name>Multidirectional harness group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stroke more than 6 months ago&#xD;
&#xD;
          -  Self-identified balance issues&#xD;
&#xD;
          -  Independent ambulation - specifically:&#xD;
&#xD;
               -  Walk at least one-half block (150') with or without standard cane or similar&#xD;
                  device&#xD;
&#xD;
               -  Stand independently for at least 30 seconds without physical assistance and&#xD;
                  without any device&#xD;
&#xD;
               -  At least ten steps without physical assistance and without any cane or similar&#xD;
                  device&#xD;
&#xD;
          -  Ability to answer two-step questions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic reaction to adhesive tapes&#xD;
&#xD;
          -  Height above 74&quot;&#xD;
&#xD;
          -  Weight above 250 lbs&#xD;
&#xD;
          -  Medical Condition - they are not eligible if they self-identify as having any&#xD;
             musculoskeletal, neuromuscular, cardiopulmonary, or other conditions that would limit&#xD;
             them from participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann Reinthal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ann Reinthal, PT, PhD</last_name>
    <phone>216-687-3576</phone>
    <email>a.karas@csuohio.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Deborah Espy, PT, PhD</last_name>
    <phone>216-687-3554</phone>
    <email>d.espy@csuohio.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cleveland State University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Reinthal, PT, PhD</last_name>
      <phone>216-687-3576</phone>
      <email>a.karas@csuohio.edu</email>
    </contact>
    <contact_backup>
      <last_name>Deborah Espy, PT, PhD</last_name>
      <phone>216-687-3554</phone>
      <email>d.espy@csuohio.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Ann Reinthal, PT, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Deborah Espy, PT, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cleveland State University</investigator_affiliation>
    <investigator_full_name>M. Ann Reinthal</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Balance Training</keyword>
  <keyword>Multidirectional harness</keyword>
  <keyword>Conventional balance training</keyword>
  <keyword>Reactive Slip Training</keyword>
  <keyword>Stroke</keyword>
  <keyword>Independent ambulation</keyword>
  <keyword>Physical therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 2, 2022</submitted>
    <returned>August 22, 2023</returned>
  </pending_results>
  <!-- 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/NCT03757026
org study id: IRB-FY2019-17
secondary id: 18IPA34170316
nct id: NCT03757026
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare conventional balance training to reactive training
      and to a novel, high intensity, harnessed training program. This study examines the impact of
      these interventions on fall risk and on a range of important aspects of balance including
      overall mobility, quality of life, and health. Participants will be 60-69 adults who had a
      stroke more than 6 months ago and who ambulate independently. Each participant will complete
      14 sessions consisting of 4 (2 pre-, 2 post-) testing sessions and 10 intervention sessions.
      The pre and post testing will be the same and will consist of clinical and survey based
      balance and quality of life assessments and treadmill based perturbed gait testing.

      The pretest will be sessions 1 and 2 will be followed by 10 intervention sessions. There will
      be 3 treatment groups: a conventional balance training group (PT), a reactive slip training
      group (Slip), and a multidirectional harness group (MHG). Participants will be randomly
      assigned to a group following screening and consent.

      The conventional balance training group (PT) will receive 10 sessions of individualized
      standard of care physical therapy with the goal of improving balance and mobility. The only
      instructions to the PT are that the focus of the course of care should be on "balance and
      mobility" and that there should be 10 sessions.

      The reactive slip training group (Slip) will complete a standing slip session using the
      current protocol of scaling slip distance and force to each individual and modulating the
      slip intensity across the session based on subject responses. The remaining nine intervention
      sessions will consist of accompanied walking for up to 45 minutes. Participants will walk at
      a comfortable pace while accompanied by a researcher.

      The multidirectional harness group (MHG) will use a harness that allows movement in all
      directions, playing selected Kinect™ active video games with varied balance demands, on
      multiple balance training surfaces (e.g., rocker board, foam, slider platform). Participants
      will wear the fall-arresting harness for all game play. Motion data will be collected during
      Sessions 2, 6, and 10.

      For all groups, two-post-test sessions will follow the intervention sessions and will be the
      same as the two-pretest session. The final session will also include reviewing the
      participants' falls diaries and setting up procedures for contacting participants weekly or
      biweekly about falls.
This study compares conventional balance training to a reactive slip protocol and novel, high
      intensity, harnessed balance training using video gaming. It examines the impact of these
      three interventions on fall risk and on aspects of balance including overall mobility,
      quality of life and community participation. The study includes 60-69 adults who had a stroke
      more than 6 months ago and who walk independently. Participants will complete 14 sessions: 4
      sessions (2 pre-, 2 post-) of testing and 10 intervention sessions. There will be one to two
      sessions per week depending on scheduling and participant preference.

      The first session will begin with screening and the consent process after which participants
      will be randomly assigned to one of the following three groups of 20-22 participants each:
      conventional balance training (PT), reactive slip training (Slip), and multi-directional
      harnessed gaming training (MHG). The first individual entering the study will be randomly
      assigned to one of the three groups, the next person will be randomly assigned to one of the
      two remaining groups, and the third person will be placed in the remaining group. This
      process will be repeated with the next group of three individuals entering the study, and so
      on. Approximately midway through the study, researchers will assess group mix for impairment
      severity levels and adjust if necessary. All 14 sessions are outlined below including
      descriptions of testing and intervention procedures.

      During session one, the screening, consent and randomization process will be followed by the
      clinical testing, falls history and falls diary initiation, then scheduling of subsequent
      visits. Participants will be questioned as to any falls within the last 12 months, and if any
      - how long ago for each fall and the circumstances of and any injuries from the fall as they
      recall them. The falls diary will be explained to the participants and participants will be
      asked to keep it during the weeks of the 14 sessions and for 6 months afterwards. The
      stability (RPS) scale will be explained to the participants and remaining clinical testing
      will be administered including the Mini-Balance Evaluation Systems Test (miniBEST). The
      limits of stability testing (LOS), including the reactive perturbation testing portion of the
      miniBEST will be performed with motion capture. If time, participant scheduling, and
      participant tolerance for activity permit, the LOS testing will be done at the second
      pre-test session because this will allow motion marker placement for one session rather than
      two, saving the participant time. If timing or participant activity tolerance do not allow,
      the LOS testing will be performed, with motion capture, at the first pre-test session.

      The second session will continue the pre-test portion of the protocol with treadmill
      perturbation testing and LOS testing. All participants will be supported in a fall-arresting
      harness for all treadmill perturbation testing. First, the treadmill will be used to measure
      the participant's normal then fast walking speeds. For perturbations, the treadmill will be
      run at the participant's determined normal walking speed. It will randomly accelerate at
      mid-stance of the hemiparetic foot, then return to its usual speed. The participant will be
      asked to try to maintain his/her balance and continue walking as before, but that if the
      participant needs to stop, the investigator will halt the treadmill and provide a rest break.
      After each perturbation, the participant will be asked to score it on the RPS scale.
      Throughout all of the treadmill perturbation testing force, motion, and load cell data will
      be recorded and vital signs will be monitored consistent with Physical Therapy and exercise
      standards.

      There will be up to 18 perturbations. The initial perturbation intensity will be based on the
      participant's miniBEST scores and normalized to that individual's maximum gait speed. Each
      subsequent perturbation intensity will be determined based on the participant's response to
      the previous perturbations: three consecutive falls (>30% of participant's body weight as
      measured by load cell) leads to a decrease in perturbation intensity; three consecutive
      recoveries (<5%of participant's body weight as measured by load cell) leads to an increase in
      perturbation intensity; and if the three previous perturbations were mixed (some combination
      of falls, recoveries, and harness assists) the perturbation will be unchanged. The outcome of
      each trial (fall, recovery, or harness assist) will be recorded.

      After pretesting, 10 intervention sessions will begin based on group assignment, as described
      above. The conventional balance training group (PT) will receive individualized standard of
      care physical therapy with the goal of improving balance and mobility during sessions 3
      through 12. This will be completed by an experienced community physical therapist who will be
      blinded to the other groups' activities and to all pre-testing results. The first visit will
      have approximately 60 minutes allotted for the initial evaluation and limited treatment while
      the remaining 9 sessions will consist of 45 minutes of PT treatment. The only instructions to
      the PT are that the focus of the course of care should be on "balance and mobility" and that
      there should be 10 sessions total. The investigators will be blinded to the specifics of the
      individual treatments provided by the PT(s).

      The reactive slip training group (Slip) will complete one standing slip session using the
      current protocol of scaling slip distance and force to each individual and modulating the
      slip intensity across the session based on participant responses. To match intervention time
      to the other two groups, the remaining 9 sessions will involve 45 minutes of supervised
      walking with vital sign and distance monitoring, and rest as necessary.

      All participants will use a full-body, fall-arresting harness throughout all slip testing.
      All participants will be informed that during the experimental procedures the Slip Trainer
      platform, on which they are standing, may move suddenly and unexpectedly under their feet.
      The participants will be asked to react as naturally as possible to the perturbation. The
      participants will also be informed that if they are unable to catch themselves, the full-body
      safety harness they will be wearing will prevent a fall from occurring. Participants will be
      reminded that they may request a rest break at any time. Participants will be guarded by an
      investigator (both licensed Physical Therapists) or by a Student PT supervised by an
      investigator.

      The Slip Trainer is a low platform on rollers which allow only anterior-posterior
      (forward-backward) slips, not side to side. Participants will stand quietly on the trainer
      and slips will be induced by the (randomly timed and unannounced) release of weights from a
      designated height, causing the weights to fall and the platform to be pulled backward or
      forward approximately 15 - 30 centimeters. The amount of weight released will range from
      15-40% of the participant's body weight. Up to 17 slips will be induced. The participants
      will self-rate their stability during the slip with the RPS immediately after each slip
      recovery. Motion, load cell and outcomes data will be collected throughout slip testing.
      Initial perturbation intensity (percent body weight and slip distance) will be based on the
      participant's miniBEST score and each subsequent perturbation intensity will be determined
      based on the participant's response to the previous perturbations. If this algorithm leads to
      the perturbations being reduced below 5% and 5 cm or above 40% and 30 cm, the trials will be
      stopped.

      The remaining nine intervention sessions will consist of accompanied walking for up to 45
      minutes. Participants will come to Cleveland State University and will walk at a comfortable
      pace while accompanied by a researcher in the areas in or adjacent to the Health Sciences
      spaces. Researchers will monitor the participants' vital signs as indicated and in the manner
      consistent with standard PT/exercise practice. Participants may request rest breaks as
      needed. The researcher will record the distances walked, the rests taken, and the vital signs
      as taken.

      The multidirectional harness group (MHG) will use a harness with the Open Area Support System
      (OASUS) multidirectional harness framework and play selected Kinect™ active video games with
      varied balance demands, while standing on multiple balance training surfaces (e.g., solid
      floor, rocker board, foam, slider platform). Participants will wear the fall-arresting
      harness in the OASUS system for all game play. This harness allows participants to move
      freely in any direction except it limits their vertical descent to a pre-set height. This
      will be adjusted to a height that allows the participants to touch the floor or support
      surface with only their feet when fully suspended in the harness in any direction; no other
      body part will be able to reach the ground. This will be re-adjusted each time the
      participant changes the playing surface.

      Initial game and training surface combinations as well as subsequent difficulty levels and
      training conditions will be chosen using a progression algorithm in conjunction with the Rate
      of Perceived Stability (RPS). Motion data will be collected during gaming for Sessions 2, 6,
      and 10. RPS scores will be collected during and immediately after all gaming sessions.
      Participants are able to use rest breaks and will be monitored throughout all sessions
      consistent with standard physical therapy/exercise practice. At the first session of MHG,
      participants will be introduced to each game and given time to practice playing that game
      until they feel comfortable with each game. All participants will progress with the
      prescribed sequence of games and surfaces, progressing based on their rating of the previous
      three bouts of play.

      Two post-test sessions will follow the 10 intervention sessions. These will be equivalent to
      the two-pretest session above with the treadmill testing at session 13, LOS testing at either
      session 13 or 14, and the remaining clinical testing and follow up at session 14. All
      participants will be reminded of previous protocols/instructions completed in their pretest
      sessions. The 14th and final session will also include reviewing the participants' falls
      diaries and setting up procedures for contacting participants weekly or biweekly about falls.
      The participant will have a chance to ask any questions about the overall study and the
      payment forms will be signed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline Activities Specific Balance Confidence Scale (ABC) at study completion
time frame: Through study completion, on average three months.
description: Indicates how self-confident the participants are not to lose their balance or become unsteady during specific activities like: walk around house, walk up and down stairs, pick up a slipper from the floor, etc. (Rating self-confidence from 0-100% on each of 16 items; then total score divided by 16 to give an overall self-confidence level, with 100% being fully confident on all 16 activities listed)
measure: Change from baseline Mini Balance Evaluation Systems Test (MiniBEST) at study completion
time frame: Through study completion, on average three months.
description: It aims to target and identify different balance control systems to identify balance deficits. The MiniBEST test is a 14-item test scored on a 3-level ordinal scale. Sections include anticipatory, reactive postural control, sensory orientation, and dynamic balance.
measure: Change from baseline Mobility life space scale (MLSS) at study completion
time frame: Through study completion, on average three months.
description: Questions for life-space mobility refers to 1) the level of the spatial area (bedroom, home, outside home, neighborhood, town, and beyond town) that an individual purposely moves through in daily life; 2) to the frequency of movement within a specific time in each area; and 3) the need for assistance with that movement. Scores range from 0 for someone who remains only the bedroom to up to 120 for someone who travels daily and independently out of his/her immediate community.
measure: Change from baseline anterior, posterior, and lateral (to right and to left sides) limits of stability (LOS) scores at study completion
time frame: Through study completion, on average three months.
description: Standing limits of stability (LOS) are tested by having the participant lean as far as he/she can to the front, back, and each side, twice, without stepping or needing to reach out for support. Motion data will be used to calculate the participant's center of mass (COM) and base of support (BOS) during this test. Then, the percent of the distance the participant can move his/her COM towards the edge of his/her BOS will be calculated in each of the four directions.
measure: Change from baseline Treadmill perturbation stability scores at study completion
time frame: Through study completion, on average three months.
description: Participants will walk on the treadmill to determine normal and maximum gait speed. Walking at normal speed, at a random time at about mid-stance of the hemiparetic lower extremity, the treadmill will accelerate suddenly then return to its previous speed. Initial perturbation intensity will be based on the participant's miniBEST scores and normalized to that individual's maximum gait speed. Each subsequent perturbation intensity will be based on the participant's response to previous perturbations: 3 consecutive falls (>30% of participant's body weight as measured by load cell) leads to a decrease in perturbation intensity; 3 consecutive recoveries (<5%) leads to an increase in perturbation intensity; and if the 3 previous perturbations were mixed (combination of falls, recoveries, and harness assists) the perturbation will be unchanged. Each response will be recorded as a recovery, harness assist, or fall (recovery <5%, harness assist 5%-30%, or fall >30% of body weight).
measure: Change from baseline Falls Diary at 6 months post study completion
time frame: Through 6 months post study completion, on average a total of 9 months including study duration plus 6 months post study follow-up.
description: During the pre-testing sessions, participants will be asked verbally to describe their recall of falls they have experienced in the past 12 months, to be recorded by a researcher, and to keep a log of falls over the course of the study and follow-up period of 6 months (to be collected monthly after end of study by phone call).
measure: Change from baseline Fugl Meyer Lower Extremity Sensory and Movement testing (FM LE) at study completion
time frame: Through study completion, on average three months.
description: Evaluates and measures recovery in post-stroke hemiplegic patients. This outcome measure assesses sensorimotor function through the lower extremity. Items are scored on a 3-point ordinal scale.
measure: Change from baseline Monofilament sensory testing (5.07 monofilament testing of foot and ankle) at study completion
time frame: Through study completion, on average three months.
description: Using 5.07 monofilament, test the bottom and top of the foot below in locations pictured, including the medial and lateral malleolus and the anterior ankle at the mid-position between the two malleoli. While holding the handle, push the monofilament at a 90-degree angle against the skin until the monofilament bows. Hold for 1.5 seconds. Record with a check mark (√) if sensation intact and an X to denote no sensation at that point.
measure: Change from baseline Five times sit-to-stand test (5XSTS) at study completion
time frame: Through study completion, on average three months.
description: Patient sits with arms folded across chest and with back against the chair. With patients who have had a stroke, it is permissible to have the impaired arm at the side or in a sling.They must stand fully between repetitions of the test and not to touch the back of the chair during each repetition. They will stand up full 5 times. Documentation of speed and assist level (CGA, supervision, Mod I, or I) will be recorded.
measure: Change from baseline Stroke Impact Scale (SIS) at study completion
time frame: Through study completion, on average three months.
description: The Stroke Impact Scale (SIS) is a questionnaire that evaluates how a stroke has impacted the participant's health and life. The SIS has eight sections measuring self-perceived strength, memory and thinking, emotion, communication, activities of daily living, mobility, hand use, and work/leisure participation. There are multiple questions in each section, with each question rated from 1 to 5 in terms of activity difficulty, activity frequency, or strength. Summary scores are generated for each of the 8 sections. The scoring uses a transformed scale [(actual raw score - lowest possible raw score) /possible raw score range] x 100) and some items must be reverse scored. Scores range from 0-100% for each section with 100% indicating the highest level of function. There is also a final ninth section rating percent overall self-perceived recovery from the stroke with 100% being fully recovered.
measure: Change from baseline Berg Balance Scale (BBS) at study completion
time frame: Through study completion, on average three months.
description: The BBS measures balance ability (static and dynamic) among older adults. The BBS is a qualitative measure that assesses balance through performing functional activities. Each item is scored on a 5-point scale, ranging from 0 to 4, zero indicating the lowest level of function and 4 the highest level of function.
arm group label: Conventional Physical Therapy
arm group type: Active Comparator
description: 20-22 participants randomly assigned to receive 10 sessions of balance training. Conventional balance training group (PT) will receive individualized standard of care physical therapy with the goal of improving balance and mobility during sessions 3 through 12. The only instructions to the PT are that the focus of the course of care should be on "balance and mobility" and that there should be 10 sessions total. The first visit will include an initial evaluation and limited treatment. While the remaining 9 sessions will consist of 45 minutes of PT treatment.
arm group label: Slip training
arm group type: Experimental
description: 20-22 participants randomly assigned to 1 session of slip training and 9 sessions of accompanied walking. Reactive slip training group (Slip) will complete a standing slip session using the current protocol of scaling slip distance and force to each individual and modulating the slip intensity across the session based on subject responses. Initial perturbation intensity (percent body weight and slip distance) will be based on the participant's miniBEST score and each subsequent perturbation intensity will be determined based on their response to the previous perturbations. The remaining nine intervention sessions will consist of accompanied walking for up to 45 minutes. Participants will walk at a comfortable pace while accompanied by a researcher around Cleveland State.
arm group label: Harnessed gaming
arm group type: Experimental
description: 20-22 participants randomly assigned to 10 sessions of harnessed gaming. Multidirectional harness group (MHG) will use a harness with the multidirectional OASUS frame and play selected Kinect™ active video games with varied balance demands, while standing on multiple balance training surfaces (e.g., solid floor, rocker board, foam, slider platform). Participants will wear the fall-arresting harness in the OASUS system for all game play. Motion data will be collected during gaming for Sessions 2, 6, and 10. Each game/surface will be played for about 5 to 6 minutes for 4 game/surface conditions per session. All participants will progress with the prescribed sequence of games and surfaces, progressing based on their rating of the previous three bouts of play.
intervention type: Other
intervention name: Conventional Physical Therapy
description: 20-22 participants randomly assigned to receive 10 sessions of balance training. Conventional balance training group (PT) will receive individualized standard of care physical therapy with the goal of improving balance and mobility during sessions 3 through 12. The only instructions to the PT are that the focus of the course of care should be on "balance and mobility" and that there should be 10 sessions total. The first visit will include an initial evaluation and limited treatment. While the remaining 9 sessions will consist of 45 minutes of PT treatment.
arm group label: Conventional Physical Therapy
other name: Balance training
intervention type: Other
intervention name: Slip Training
description: 20-22 participants randomly assigned to 1 session of slip training and 9 sessions of accompanied walking. Reactive slip training group (Slip) will complete a standing slip session using the current protocol of scaling slip distance and force to each individual and modulating the slip intensity across the session based on subject responses. Initial perturbation intensity (percent body weight and slip distance) will be based on the participant's miniBEST score and each subsequent perturbation intensity will be determined based on their response to the previous perturbations. The remaining nine interventional sessions will consist of accompanied walking for up to 45 minutes. Participants will walk at a comfortable pace while accompanied by a researcher around Cleveland State.
arm group label: Slip training
other name: Reactive slip training
intervention type: Other
intervention name: Harnessed gaming
description: 20-22 participants randomly assigned to 10 sessions of harnessed gaming. Multidirectional harness group (MHG) will use a harness with the multidirectional OASUS frame and play selected Kinect™ active video games with varied balance demands, while standing on multiple balance training surfaces (e.g., solid floor, rocker board, foam, slider platform). Participants will wear the fall-arresting harness in the OASUS system for all game play. Motion data will be collected during gaming for Sessions 2, 6, and 10. Each game/surface will be played for about 5 to 6 minutes for 4 game/surface conditions per session. All participants will progress with the prescribed sequence of games and surfaces, progressing based on their rating of the previous three bouts of play.
arm group label: Harnessed gaming
other name: Multidirectional harness group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ann Reinthal
role: Principal Investigator
affiliation: Cleveland State University
last name: Ann Reinthal, PT, PhD
phone: 216-687-3576
email: a.karas@csuohio.edu
last name: Deborah Espy, PT, PhD
phone: 216-687-3554
email: d.espy@csuohio.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cleveland State University
investigator full name: M. Ann Reinthal
investigator title: Associate Professor
mesh term: Stroke
sharing ipd: Undecided
submitted: October 2, 2022
returned: August 22, 2023