<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/NCT04498429</url>
  </required_header>
  <id_info>
    <org_study_id>5200090</org_study_id>
    <nct_id>NCT04498429</nct_id>
  </id_info>
  <brief_title>Effect of Integrated Cueing on Functional Transfers in Chronic Stroke Survivors</brief_title>
  <acronym>EOIC</acronym>
  <official_title>Effect of Integrated Manual and Verbal Cueing on Functional Transfers in Chronic Stroke Survivors: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</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>
      Physical therapists frequently use manual cueing as a tool to improve movement quality in&#xD;
      persons recovering from stroke but evidence to support its effectiveness is lacking.&#xD;
&#xD;
      The purpose of this graduate student research study is to determine the immediate and&#xD;
      carryover effects of an integrated verbal and manual facilitation approach used by physical&#xD;
      therapists during sit to stand training on the midline alignment, muscle activation and&#xD;
      quality of movement in chronic stroke survivors with hemiplegia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over the last few decades, the profession of physical therapy has heavily relied on manual&#xD;
      facilitation to improve motor control and functional movement in persons recovering from&#xD;
      stroke or other neurological impairments. In the 1950's, Berta Bobath created&#xD;
      Neuro-Developmental Treatment (NDT), a systematic problem-solving approach that is one of the&#xD;
      most widely used methodologies in neurorehabilitation. NDT relies heavily on verbal and&#xD;
      tactile facilitation as an integrated approach to improve motor control in persons with&#xD;
      hemiplegia. However, current systematic reviews have stated that adequate evidence for the&#xD;
      effectiveness of neuro facilitation is lacking. In the current climate of evidence-based&#xD;
      practice, neurologic physical therapists no longer blindly accept the use of traditional&#xD;
      interventions and instead rely on peer-reviewed research studies to support their clinical&#xD;
      decision-making.&#xD;
&#xD;
      However, the question remains for many physical therapists: are skilled manual cues really an&#xD;
      essential ingredient in the post-stroke recipe? Most practicing neurologic physical&#xD;
      therapists would claim that their hands are their most valuable tools and that the way in&#xD;
      which they use their hands has a direct effect on movement patterns and functional outcomes&#xD;
      with their patients. Ploughman and colleagues reported that manual tactile cues during gait&#xD;
      had &quot;robust but short-lived impacts on cadence and time in double support&quot; during gait but&#xD;
      their findings are merely a step in the right direction. An integrative approach of both&#xD;
      manual and verbal cues have anecdotally shown to be effective to treat impairments from&#xD;
      stroke but there continues to be a dearth of evidence to accurately support the pervasive use&#xD;
      of manual facilitation by physical therapists. While support for manual tactile cueing is&#xD;
      merely beginning to move in the right direction, strong evidence exists that task specific&#xD;
      training can improve functional outcomes by focusing training on desired movements and&#xD;
      activities. But what part does manual cueing truly play in task specific training? Sit to&#xD;
      stand is an essential activity of daily living that is often impaired in stroke survivors and&#xD;
      is commonly trained by physical therapists from both task specific training and NDT schools&#xD;
      of thought. Physical therapists need further clarification as to which methods are most&#xD;
      effective for facilitating maximum learning and recovery during this functional task in order&#xD;
      to craft an ideal recipe.&#xD;
&#xD;
      Training correct movement patterns in order to improve functional independence is important&#xD;
      at every stage of recovery after stroke. Kerr et al. suggested that successful sit to stand&#xD;
      movements require proper training of the critical timing of events as well as improving&#xD;
      synergistic activation of the appropriate lower limb musculature. Ultimately, asymmetry can&#xD;
      lead to a conditioned suppression of available movement termed &quot;learned non-use&quot;. Continual&#xD;
      reinforcement of poor movement strategies thus leads to passive suppression of maximally&#xD;
      efficient normal movements unless the stroke survivor is actively retrained to unlock masked&#xD;
      abilities over time. Teasell and colleagues confirmed the importance of skilled&#xD;
      rehabilitation throughout all phases of recovery including the chronic stroke phase, though&#xD;
      this important population regularly experiences fewer opportunities to participate in therapy&#xD;
      as time progresses. Measurable gains may be slower at this stage but the ability to perform&#xD;
      essential mobility tasks remains just as important to the individual.&#xD;
&#xD;
      Thus, the purpose of this graduate student research study is to determine the immediate and&#xD;
      carryover effects of an integrated verbal and manual facilitation approach during sit to&#xD;
      stand training on the midline alignment, muscle activation and quality of movement in chronic&#xD;
      stroke survivors with hemiplegia. By determining the essential ingredients that lead to an&#xD;
      ideal recipe for success, physical therapists may have more evidence-based tools available to&#xD;
      maximize the independence, quality of life and confidence of their patients.&#xD;
&#xD;
      Procedures: Session 1: All participants will complete the initial paperwork and then be&#xD;
      randomized into Verbal Cueing Group or Verbal + Manual Cueing Group using envelopes that are&#xD;
      predetermined from a random number table. Height will be assessed using a stadiometer and&#xD;
      weight using a scale. Subjects will then have trajectory markers and surface&#xD;
      electromyographic (EMG) sensors placed according to the chart. This includes 24 individual&#xD;
      marker trajectories, two thigh clusters and two shank clusters of four trajectories each for&#xD;
      a total of 40 markers and 6 surface EMG sensors that will be placed on major muscle groups of&#xD;
      the lower extremities. Once the setup has been completed and verified, the subject will&#xD;
      perform two static standing trials, followed by two initial sit to stand (STS) trials to&#xD;
      determine their baseline variables. This format will be followed by both the Verbal Cueing&#xD;
      and the Verbal + Manual Cueing throughout the treatment session. The first 5 repetitions of&#xD;
      both groups will include part to whole task practice of partial sit to stand using scripted&#xD;
      verbal cueing to facilitate understanding of the task. The goal of both groups is to improve&#xD;
      midline orientation and alignment during the task of moving from sitting to standing.&#xD;
&#xD;
      After the first 5 repetitions, the subject will perform two sit to stand trials on their own&#xD;
      following the clinician's scripted verbal commands. Next, five Manual + Verbal Cueing or&#xD;
      Verbal Cueing trials will commence followed by another two PostCue trials. This repeated&#xD;
      sequence of 5 cued trials followed by 2 assessment trials will continue for a total of 40 sit&#xD;
      to stand trials. After a 5-minute rest period the subject will then be asked to perform two&#xD;
      additional STS to determine retention of learning over that interval. Next, two isometrically&#xD;
      resisted sit to stand trials will be performed for EMG normalization. Once the EMG&#xD;
      normalization is completed, the subject will then be told they are done and may get up to&#xD;
      leave. When they get up to leave, their sit to stand activity will also be discretely&#xD;
      recorded for comparison to their last knowingly observed trial. This is based on the Actual&#xD;
      Amount of Use Test (AAOUT) in which subjects are observed under normal circumstances to&#xD;
      assess whether the learning was integrated into functional use when the subject doesn't think&#xD;
      they are being observed.&#xD;
&#xD;
      At the end of session #1, the investigator will ask the subject what strategy most helped&#xD;
      them achieve midline. Based on their feedback, the investigator will create and issue a home&#xD;
      exercise program (HEP) handout that incorporates that subjective report. Examples include&#xD;
      statements such as, &quot;Feeling the pressure through my left leg&quot; or &quot;Leaning to my left&quot;. This&#xD;
      cue will be placed on a brightly colored card that will be placed near where the subject&#xD;
      practices sitting to standing most often in their home environment. The card will also&#xD;
      contain an easy to mark log to encourage practice of the STS task over the next 3-5 days. The&#xD;
      subject will be instructed to perform the exercises at the times specified on the card using&#xD;
      the subject's subjective to help encourage maximal midline orientation. Permission will be&#xD;
      obtained to text the subject on a regular basis to remind them to perform the exercises.&#xD;
&#xD;
      Session 2: Participants who choose to return will come back within 3 to 5 days of Session #1.&#xD;
      Subjects will be asked to bring their HEP card to verify compliance via the practice log.&#xD;
      After placement of the trajectory markers (but not the EMG), subjects will be asked to&#xD;
      perform two trials of sit to stand, regardless of their original group. They will then be&#xD;
      assessed with the AAOUT test in the same manner as the end of session #1. Afterward,&#xD;
      participants in the Verbal Cueing group will be offered the Integrated Cueing approach if&#xD;
      they so choose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 6, 2020</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Midline Orientation via Symmetry Ratio</measure>
    <time_frame>Baseline and immediately after the intervention</time_frame>
    <description>The participant's ability to equally distribute their weight throughout the sit to stand task will be measured via two force plates integrated with the Qualisys motion capture system. The ratio is calculated via dividing the weight on the hemiparetic leg by the weight on the non-hemiparetic side. A score of 1 indicates equal weight bearing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Midline Orientation via Trunk Lateral Lean angle</measure>
    <time_frame>Baseline and immediately after the intervention</time_frame>
    <description>The participant's ability to maintain an upright trunk throughout the sit to stand task as measured by computations from the Qualisys motion capture system using 40 trajectory markers. Perfect midline orientation would be a value of 0 degrees indicating midline orientation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Activation</measure>
    <time_frame>During after the intervention</time_frame>
    <description>Comparison of muscle activation between normal and hemiparetic lower extremity extensor muscle groups as measured with surface electromyography (EMG) and processed through the Qualisys motion capture system. Change will be indicated by subtracting max contraction per various extensor muscle groups as a composite measure during the activity from initial max contraction of the same muscle group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to complete Sit to Stand Activity</measure>
    <time_frame>Baseline and immediately after the intervention</time_frame>
    <description>A measurement of the total elapsed time to perform the sit to stand activity as measured from initial movement to highest position of center of mass</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hemiplegia and/or Hemiparesis Following Stroke</condition>
  <arm_group>
    <arm_group_label>Integrated Manual and Verbal Cueing Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A series of 40 training repetitions of sit to stand using the Integrated/Manual Cueing intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Verbal Cueing Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A series of 40 training repetitions of sit to stand using the Verbal Cueing intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Integrated Cueing Protocol</intervention_name>
    <description>The first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. In addition to verbal cueing, the manual cueing group will receive hands-on tactile facilitation from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions.</description>
    <arm_group_label>Integrated Manual and Verbal Cueing Group</arm_group_label>
    <other_name>Manual Cueing Protocol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Verbal Cueing Protocol</intervention_name>
    <description>The first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. The verbal cueing protocol consists of verbal cueing from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions.</description>
    <arm_group_label>Verbal Cueing Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic Right CVA with left hemiplegia &gt; 6 Months&#xD;
&#xD;
          -  Able to ambulate with no more than help than supervision&#xD;
&#xD;
          -  Must be able to stand without an assistive device or ankle foot orthosis&#xD;
&#xD;
          -  Must be able to follow two-step verbal commands&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of injury from a recent fall within the last 3 months&#xD;
&#xD;
          -  Currently participating in rehabilitation during the time frame of their participation&#xD;
             in this study&#xD;
&#xD;
          -  Additional musculoskeletal or neurological conditions that may impair ability to&#xD;
             perform sit to stand safely&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric G Johnson, DSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eric G Johnson, DSc</last_name>
    <phone>(909) 558-4632</phone>
    <phone_ext>47471</phone_ext>
    <email>ejohnson@llu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Todd C Nelson, DPT</last_name>
    <phone>9095584632</phone>
    <phone_ext>87476</phone_ext>
    <email>tnelson@llu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Loma Linda University Health</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92350</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Todd C Nelson, DPT</last_name>
      <phone>909-558-4632</phone>
      <phone_ext>87476</phone_ext>
      <email>TNelson@llu.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Loma Linda University</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92350</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Todd C Nelson, DPT</last_name>
      <phone>909-558-4632</phone>
      <phone_ext>87476</phone_ext>
      <email>TNelson@llu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Facilitation</keyword>
  <keyword>Sit-to-Stand</keyword>
  <keyword>Manual Cueing</keyword>
  <keyword>Verbal Cueing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Hemiplegia</mesh_term>
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual data will not be shared</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04498429
org study id: 5200090
nct id: NCT04498429
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Physical therapists frequently use manual cueing as a tool to improve movement quality in
      persons recovering from stroke but evidence to support its effectiveness is lacking.

      The purpose of this graduate student research study is to determine the immediate and
      carryover effects of an integrated verbal and manual facilitation approach used by physical
      therapists during sit to stand training on the midline alignment, muscle activation and
      quality of movement in chronic stroke survivors with hemiplegia.
Over the last few decades, the profession of physical therapy has heavily relied on manual
      facilitation to improve motor control and functional movement in persons recovering from
      stroke or other neurological impairments. In the 1950's, Berta Bobath created
      Neuro-Developmental Treatment (NDT), a systematic problem-solving approach that is one of the
      most widely used methodologies in neurorehabilitation. NDT relies heavily on verbal and
      tactile facilitation as an integrated approach to improve motor control in persons with
      hemiplegia. However, current systematic reviews have stated that adequate evidence for the
      effectiveness of neuro facilitation is lacking. In the current climate of evidence-based
      practice, neurologic physical therapists no longer blindly accept the use of traditional
      interventions and instead rely on peer-reviewed research studies to support their clinical
      decision-making.

      However, the question remains for many physical therapists: are skilled manual cues really an
      essential ingredient in the post-stroke recipe? Most practicing neurologic physical
      therapists would claim that their hands are their most valuable tools and that the way in
      which they use their hands has a direct effect on movement patterns and functional outcomes
      with their patients. Ploughman and colleagues reported that manual tactile cues during gait
      had "robust but short-lived impacts on cadence and time in double support" during gait but
      their findings are merely a step in the right direction. An integrative approach of both
      manual and verbal cues have anecdotally shown to be effective to treat impairments from
      stroke but there continues to be a dearth of evidence to accurately support the pervasive use
      of manual facilitation by physical therapists. While support for manual tactile cueing is
      merely beginning to move in the right direction, strong evidence exists that task specific
      training can improve functional outcomes by focusing training on desired movements and
      activities. But what part does manual cueing truly play in task specific training? Sit to
      stand is an essential activity of daily living that is often impaired in stroke survivors and
      is commonly trained by physical therapists from both task specific training and NDT schools
      of thought. Physical therapists need further clarification as to which methods are most
      effective for facilitating maximum learning and recovery during this functional task in order
      to craft an ideal recipe.

      Training correct movement patterns in order to improve functional independence is important
      at every stage of recovery after stroke. Kerr et al. suggested that successful sit to stand
      movements require proper training of the critical timing of events as well as improving
      synergistic activation of the appropriate lower limb musculature. Ultimately, asymmetry can
      lead to a conditioned suppression of available movement termed "learned non-use". Continual
      reinforcement of poor movement strategies thus leads to passive suppression of maximally
      efficient normal movements unless the stroke survivor is actively retrained to unlock masked
      abilities over time. Teasell and colleagues confirmed the importance of skilled
      rehabilitation throughout all phases of recovery including the chronic stroke phase, though
      this important population regularly experiences fewer opportunities to participate in therapy
      as time progresses. Measurable gains may be slower at this stage but the ability to perform
      essential mobility tasks remains just as important to the individual.

      Thus, the purpose of this graduate student research study is to determine the immediate and
      carryover effects of an integrated verbal and manual facilitation approach during sit to
      stand training on the midline alignment, muscle activation and quality of movement in chronic
      stroke survivors with hemiplegia. By determining the essential ingredients that lead to an
      ideal recipe for success, physical therapists may have more evidence-based tools available to
      maximize the independence, quality of life and confidence of their patients.

      Procedures: Session 1: All participants will complete the initial paperwork and then be
      randomized into Verbal Cueing Group or Verbal + Manual Cueing Group using envelopes that are
      predetermined from a random number table. Height will be assessed using a stadiometer and
      weight using a scale. Subjects will then have trajectory markers and surface
      electromyographic (EMG) sensors placed according to the chart. This includes 24 individual
      marker trajectories, two thigh clusters and two shank clusters of four trajectories each for
      a total of 40 markers and 6 surface EMG sensors that will be placed on major muscle groups of
      the lower extremities. Once the setup has been completed and verified, the subject will
      perform two static standing trials, followed by two initial sit to stand (STS) trials to
      determine their baseline variables. This format will be followed by both the Verbal Cueing
      and the Verbal + Manual Cueing throughout the treatment session. The first 5 repetitions of
      both groups will include part to whole task practice of partial sit to stand using scripted
      verbal cueing to facilitate understanding of the task. The goal of both groups is to improve
      midline orientation and alignment during the task of moving from sitting to standing.

      After the first 5 repetitions, the subject will perform two sit to stand trials on their own
      following the clinician's scripted verbal commands. Next, five Manual + Verbal Cueing or
      Verbal Cueing trials will commence followed by another two PostCue trials. This repeated
      sequence of 5 cued trials followed by 2 assessment trials will continue for a total of 40 sit
      to stand trials. After a 5-minute rest period the subject will then be asked to perform two
      additional STS to determine retention of learning over that interval. Next, two isometrically
      resisted sit to stand trials will be performed for EMG normalization. Once the EMG
      normalization is completed, the subject will then be told they are done and may get up to
      leave. When they get up to leave, their sit to stand activity will also be discretely
      recorded for comparison to their last knowingly observed trial. This is based on the Actual
      Amount of Use Test (AAOUT) in which subjects are observed under normal circumstances to
      assess whether the learning was integrated into functional use when the subject doesn't think
      they are being observed.

      At the end of session #1, the investigator will ask the subject what strategy most helped
      them achieve midline. Based on their feedback, the investigator will create and issue a home
      exercise program (HEP) handout that incorporates that subjective report. Examples include
      statements such as, "Feeling the pressure through my left leg" or "Leaning to my left". This
      cue will be placed on a brightly colored card that will be placed near where the subject
      practices sitting to standing most often in their home environment. The card will also
      contain an easy to mark log to encourage practice of the STS task over the next 3-5 days. The
      subject will be instructed to perform the exercises at the times specified on the card using
      the subject's subjective to help encourage maximal midline orientation. Permission will be
      obtained to text the subject on a regular basis to remind them to perform the exercises.

      Session 2: Participants who choose to return will come back within 3 to 5 days of Session #1.
      Subjects will be asked to bring their HEP card to verify compliance via the practice log.
      After placement of the trajectory markers (but not the EMG), subjects will be asked to
      perform two trials of sit to stand, regardless of their original group. They will then be
      assessed with the AAOUT test in the same manner as the end of session #1. Afterward,
      participants in the Verbal Cueing group will be offered the Integrated Cueing approach if
      they so choose.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Midline Orientation via Symmetry Ratio
time frame: Baseline and immediately after the intervention
description: The participant's ability to equally distribute their weight throughout the sit to stand task will be measured via two force plates integrated with the Qualisys motion capture system. The ratio is calculated via dividing the weight on the hemiparetic leg by the weight on the non-hemiparetic side. A score of 1 indicates equal weight bearing.
measure: Midline Orientation via Trunk Lateral Lean angle
time frame: Baseline and immediately after the intervention
description: The participant's ability to maintain an upright trunk throughout the sit to stand task as measured by computations from the Qualisys motion capture system using 40 trajectory markers. Perfect midline orientation would be a value of 0 degrees indicating midline orientation.
measure: Muscle Activation
time frame: During after the intervention
description: Comparison of muscle activation between normal and hemiparetic lower extremity extensor muscle groups as measured with surface electromyography (EMG) and processed through the Qualisys motion capture system. Change will be indicated by subtracting max contraction per various extensor muscle groups as a composite measure during the activity from initial max contraction of the same muscle group.
measure: Time to complete Sit to Stand Activity
time frame: Baseline and immediately after the intervention
description: A measurement of the total elapsed time to perform the sit to stand activity as measured from initial movement to highest position of center of mass
arm group label: Integrated Manual and Verbal Cueing Group
arm group type: Experimental
description: A series of 40 training repetitions of sit to stand using the Integrated/Manual Cueing intervention.
arm group label: Verbal Cueing Group
arm group type: Experimental
description: A series of 40 training repetitions of sit to stand using the Verbal Cueing intervention
intervention type: Other
intervention name: Integrated Cueing Protocol
description: The first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. In addition to verbal cueing, the manual cueing group will receive hands-on tactile facilitation from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions.
arm group label: Integrated Manual and Verbal Cueing Group
other name: Manual Cueing Protocol
intervention type: Other
intervention name: Verbal Cueing Protocol
description: The first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. The verbal cueing protocol consists of verbal cueing from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions.
arm group label: Verbal Cueing Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
healthy volunteers: No
last name: Eric G Johnson, DSc
role: Principal Investigator
affiliation: Loma Linda University
last name: Eric G Johnson, DSc
phone: (909) 558-4632
phone ext: 47471
email: ejohnson@llu.edu
last name: Todd C Nelson, DPT
phone: 9095584632
phone ext: 87476
email: tnelson@llu.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Hemiplegia
mesh term: Paresis
sharing ipd: No
ipd description: Individual data will not be shared