<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/NCT04434443</url>
  </required_header>
  <id_info>
    <org_study_id>B-ER-106-428</org_study_id>
    <nct_id>NCT04434443</nct_id>
  </id_info>
  <brief_title>Effects of Trunk Exercise on Trunk Control and Balance in Persons With Stroke</brief_title>
  <official_title>Effects of Trunk Exercise on Unstable Surface on Trunk Control and Balance in Persons With Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng Kung University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tainan Hospital, Ministry of Health and Welfare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cheng Kung 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>
      This study examined the effects of trunk exercise on unstable surfaces on trunk control and&#xD;
      balance for persons in the sub-acute stage of stroke. The hypothesis was that, compared to&#xD;
      upper limb exercises in well supported sitting position, this exercise would lead to better&#xD;
      trunk control and sitting and standing balance. The results supported the hypothesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inpatients in the sub-acute stage of stroke were randomly assigned to receive upper limb&#xD;
      range of motion exercises in well supported sitting position or trunk exercises on unstable&#xD;
      surfaces in supine and sitting, 30 min per session, 2 sessions per week for 6 weeks, in&#xD;
      addition to their daily conventional stroke rehabilitation. Sensorimotor functions, including&#xD;
      hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and&#xD;
      Fugl-Meyer lower extremity motor scale, and clinical outcome assessments, including Trunk&#xD;
      Impairment Scale and 6-meter walk test, were conducted by a blinded assessor. Biomechanical&#xD;
      outcome measures included center of pressure area while maintaining static posture and peak&#xD;
      displacement while leaning forward, and the average speed of the unaffected arm raising (to&#xD;
      represent the ability to provide a stable foundation for focal movement). These measures were&#xD;
      taken in sitting without foot support, sitting with foot support and standing to reflect&#xD;
      trunk control, sitting balance and standing balance, respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2018</start_date>
  <completion_date type="Actual">October 6, 2019</completion_date>
  <primary_completion_date type="Actual">October 6, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome assessor not aware of group assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Center of pressure</measure>
    <time_frame>6 weeks</time_frame>
    <description>range of displacement (cm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Angular velocity of the non-affected arm raising</measure>
    <time_frame>6 weeks</time_frame>
    <description>mean velocity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trunk Impairment Scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>total score (0-23); higher scores mean better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-meter walking tests</measure>
    <time_frame>6 weeks</time_frame>
    <description>time (sec) to walk 6 meters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Cerebrovascular Accident</condition>
  <condition>Balance Impairment</condition>
  <arm_group>
    <arm_group_label>trunk exercise on unstable surface</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>trunk exercise training in supine and sitting positions, with unstable surfaces</description>
  </arm_group>
  <arm_group>
    <arm_group_label>upper limb range of motion exercise</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>upper limb range of motion exercise in sitting with back fully supported</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>trunk exercise on unstable exercise</intervention_name>
    <description>Participants would receive exercises on unstable surface. Started from supine position, participants had abdominal drawer-in maneuver with soft foam under the pelvic. Lower trunk rotation, bridging and abdominal muscles isometric contraction exercises were also used in this exercise during supine position, with different unstable surfaces used. Including soft foam under the feet, then progressed to BOSU ball under the feet, then progressed to the a BOSU ball under the feet combined with pelvic on soft foam. During sitting, BOSU ball and Swiss ball were used as unstable surface. Pelvic anterior-posterior tilt, lateral tilting, rotation, lifting, and stepping with arm swing were used in this position.</description>
    <arm_group_label>trunk exercise on unstable surface</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Upper limb range of motion exercise</intervention_name>
    <description>Upper limb range of motion exercise with trunk fully supported</description>
    <arm_group_label>upper limb range of motion exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: between 20-80 years old&#xD;
&#xD;
          -  first time stroke&#xD;
&#xD;
          -  could sit without back support at least 20 seconds&#xD;
&#xD;
          -  could understand and follow experimental instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medically unstable&#xD;
&#xD;
          -  other neuromuscular/musculoskeletal problems that would affect balance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Cheng Kung University</name>
      <address>
        <city>Tainan</city>
        <zip>701</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng Kung University</investigator_affiliation>
    <investigator_full_name>Sang-I Lin</investigator_full_name>
    <investigator_title>Professor, Department of Physical Therapy, National Cheng Kung University</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>balance</keyword>
  <keyword>Trunk exercise</keyword>
  <keyword>Trunk control</keyword>
  <keyword>standing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04434443
org study id: B-ER-106-428
nct id: NCT04434443
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examined the effects of trunk exercise on unstable surfaces on trunk control and
      balance for persons in the sub-acute stage of stroke. The hypothesis was that, compared to
      upper limb exercises in well supported sitting position, this exercise would lead to better
      trunk control and sitting and standing balance. The results supported the hypothesis.
Inpatients in the sub-acute stage of stroke were randomly assigned to receive upper limb
      range of motion exercises in well supported sitting position or trunk exercises on unstable
      surfaces in supine and sitting, 30 min per session, 2 sessions per week for 6 weeks, in
      addition to their daily conventional stroke rehabilitation. Sensorimotor functions, including
      hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and
      Fugl-Meyer lower extremity motor scale, and clinical outcome assessments, including Trunk
      Impairment Scale and 6-meter walk test, were conducted by a blinded assessor. Biomechanical
      outcome measures included center of pressure area while maintaining static posture and peak
      displacement while leaning forward, and the average speed of the unaffected arm raising (to
      represent the ability to provide a stable foundation for focal movement). These measures were
      taken in sitting without foot support, sitting with foot support and standing to reflect
      trunk control, sitting balance and standing balance, respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome assessor not aware of group assignment
measure: Center of pressure
time frame: 6 weeks
description: range of displacement (cm)
measure: Angular velocity of the non-affected arm raising
time frame: 6 weeks
description: mean velocity
measure: Trunk Impairment Scale
time frame: 6 weeks
description: total score (0-23); higher scores mean better outcome
measure: 6-meter walking tests
time frame: 6 weeks
description: time (sec) to walk 6 meters
arm group label: trunk exercise on unstable surface
arm group type: Experimental
description: trunk exercise training in supine and sitting positions, with unstable surfaces
arm group label: upper limb range of motion exercise
arm group type: Sham Comparator
description: upper limb range of motion exercise in sitting with back fully supported
intervention type: Other
intervention name: trunk exercise on unstable exercise
description: Participants would receive exercises on unstable surface. Started from supine position, participants had abdominal drawer-in maneuver with soft foam under the pelvic. Lower trunk rotation, bridging and abdominal muscles isometric contraction exercises were also used in this exercise during supine position, with different unstable surfaces used. Including soft foam under the feet, then progressed to BOSU ball under the feet, then progressed to the a BOSU ball under the feet combined with pelvic on soft foam. During sitting, BOSU ball and Swiss ball were used as unstable surface. Pelvic anterior-posterior tilt, lateral tilting, rotation, lifting, and stepping with arm swing were used in this position.
arm group label: trunk exercise on unstable surface
intervention type: Other
intervention name: Upper limb range of motion exercise
description: Upper limb range of motion exercise with trunk fully supported
arm group label: upper limb range of motion exercise
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng Kung University
investigator full name: Sang-I Lin
investigator title: Professor, Department of Physical Therapy, National Cheng Kung University
mesh term: Stroke