<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/NCT03230370</url>
  </required_header>
  <id_info>
    <org_study_id>N201705071</org_study_id>
    <nct_id>NCT03230370</nct_id>
  </id_info>
  <brief_title>Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke?</brief_title>
  <official_title>Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke? A Multicenter Randomized Controlled Study (TIARAS Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University WanFang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University WanFang Hospital</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>
      Study purpose This study will explore whether an additional rehabilitation program that focus&#xD;
      on either upper or lower extremity training facilitate the recovery in upper or lower&#xD;
      extremity.&#xD;
&#xD;
      The recovery in both neurological status and motor functions will be explored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design A single-blinded (assessor-blinded) randomized controlled trial. Interventions The&#xD;
      participants will be randomly assigned into two experiment groups (enhanced upper extremity&#xD;
      program; and enhanced lower-extremity program).&#xD;
&#xD;
      Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50&#xD;
      mins of occupational therapy.&#xD;
&#xD;
      The enhanced upper extremity program group receives additional daily 50 mins program focusing&#xD;
      on training of the hemiplegic upper extremity, while the enhanced lower-extremity program&#xD;
      group receives additional daily 50 mins program focusing on training of the hemiplegic lower&#xD;
      extremity. The participants receive 20-day training over a 4-week period. The additional&#xD;
      program is designed to be specific to either upper-extremity or lower-extremity. Accordingly,&#xD;
      one group can be used as the control group of the other one.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No adequate funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">May 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 20, 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (upper extremity subscale)</measure>
    <time_frame>0-, 4- week</time_frame>
    <description>The primary outcome is the change from baseline upper extremity subscale of Fugl-Meyer assessment at the end to 4-wk (post-intervention).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm Test (ARAT)</measure>
    <time_frame>0-, 4-, 8-, 12-, 24 week</time_frame>
    <description>A test that measures the upper extremity motor functions after the stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Test</measure>
    <time_frame>0-, 4-, 8-, 12-, 24 week</time_frame>
    <description>A test that measures the balance functions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment (lower extremity subscale)</measure>
    <time_frame>0-, 4-, 8-, 12-, 24 week</time_frame>
    <description>The FMA-LE (0-34) measures the lower extremity motor functions after the stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment (upper extremity subscale)</measure>
    <time_frame>0-, 4-, 8-, 12-, 24 week</time_frame>
    <description>FMA-UE (0-66), the subscale of FMA that measures the poststroke neuro-motor functions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time required for 10 meter walking</measure>
    <time_frame>0-, 4-, 8-, 12-, 24 week</time_frame>
    <description>measuring the walking speed over a 10-meter distance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale</measure>
    <time_frame>0-, 4-, 8-, 12-, 24 week</time_frame>
    <description>A measure for stroke-specific quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel Index</measure>
    <time_frame>0-, 4-, 8-, 12-, 24 week</time_frame>
    <description>to measure the activity of daily living</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Poststroke/CVA Hemiparesis</condition>
  <arm_group>
    <arm_group_label>enhanced upper-extremity program, EUEP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy.&#xD;
The EUP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity.&#xD;
The participants receive 20-day training over a 4-weekperiod. The additional program is designed to be specific to either upper-extremity or lower-extremity.&#xD;
Accordingly, one group can be used as the control group of the other one.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>enhanced lower-extremity program,ELLP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy.&#xD;
The ELP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.&#xD;
The participants receive 20-day training over a4-weekperiod. The additional program is designed to be specific to either upper-extremity or lower-extremity.&#xD;
Accordingly,one group can be used as the control group of the other one.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>UFT</intervention_name>
    <description>The EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity,</description>
    <arm_group_label>enhanced upper-extremity program, EUEP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LFT</intervention_name>
    <description>The ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.</description>
    <arm_group_label>enhanced lower-extremity program,ELLP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. First-ever stroke with the onset 10-90 days prior to the enrollment&#xD;
&#xD;
          2. Age: 20-80y&#xD;
&#xD;
          3. With a hemiplegic upper extremity with Brunnstrom stage in I~IV&#xD;
&#xD;
          4. Able to understand simple orders (1-step orders, such as &quot;raise your hand, touch your&#xD;
             head….)&#xD;
&#xD;
          5. Totally independent in activity of daily life before the onset of stroke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Incompliance to the assessments or interventions due to unstable medical condition,&#xD;
             abnormal cognition, or other conditions.&#xD;
&#xD;
          2. Stroke of brainstem or cerebellum&#xD;
&#xD;
          3. Had received craniotomy or ventriculoperitoneal shunting&#xD;
&#xD;
          4. Needs of orthoses in walking before the onset of stroke&#xD;
&#xD;
          5. Had had motor dysfunctions (eg, amputation, cerebral palsy, poliomyelitis or other&#xD;
             neuromuscular diseases) before the stroke.&#xD;
&#xD;
          6. Intracranial hemorrhage caused by artereovenous malformation, aneurysm, or tumor&#xD;
&#xD;
          7. Able to walk independently for more than 50 meters.&#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>WanFang Hospital</name>
      <address>
        <city>New Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University WanFang Hospital</investigator_affiliation>
    <investigator_full_name>Yen-Nung Lin</investigator_full_name>
    <investigator_title>Director of Rehabilitation Department of Taipei Medical University WanFang Hospital</investigator_title>
  </responsible_party>
  <keyword>intensity</keyword>
  <keyword>rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03230370
org study id: N201705071
nct id: NCT03230370
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study purpose This study will explore whether an additional rehabilitation program that focus
      on either upper or lower extremity training facilitate the recovery in upper or lower
      extremity.

      The recovery in both neurological status and motor functions will be explored.
Design A single-blinded (assessor-blinded) randomized controlled trial. Interventions The
      participants will be randomly assigned into two experiment groups (enhanced upper extremity
      program; and enhanced lower-extremity program).

      Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50
      mins of occupational therapy.

      The enhanced upper extremity program group receives additional daily 50 mins program focusing
      on training of the hemiplegic upper extremity, while the enhanced lower-extremity program
      group receives additional daily 50 mins program focusing on training of the hemiplegic lower
      extremity. The participants receive 20-day training over a 4-week period. The additional
      program is designed to be specific to either upper-extremity or lower-extremity. Accordingly,
      one group can be used as the control group of the other one.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Fugl-Meyer Assessment (upper extremity subscale)
time frame: 0-, 4- week
description: The primary outcome is the change from baseline upper extremity subscale of Fugl-Meyer assessment at the end to 4-wk (post-intervention).
measure: Action Research Arm Test (ARAT)
time frame: 0-, 4-, 8-, 12-, 24 week
description: A test that measures the upper extremity motor functions after the stroke.
measure: Berg Balance Test
time frame: 0-, 4-, 8-, 12-, 24 week
description: A test that measures the balance functions.
measure: Fugl-Meyer Assessment (lower extremity subscale)
time frame: 0-, 4-, 8-, 12-, 24 week
description: The FMA-LE (0-34) measures the lower extremity motor functions after the stroke.
measure: Fugl-Meyer Assessment (upper extremity subscale)
time frame: 0-, 4-, 8-, 12-, 24 week
description: FMA-UE (0-66), the subscale of FMA that measures the poststroke neuro-motor functions.
measure: Time required for 10 meter walking
time frame: 0-, 4-, 8-, 12-, 24 week
description: measuring the walking speed over a 10-meter distance
measure: Stroke Impact Scale
time frame: 0-, 4-, 8-, 12-, 24 week
description: A measure for stroke-specific quality of life
measure: Barthel Index
time frame: 0-, 4-, 8-, 12-, 24 week
description: to measure the activity of daily living
arm group label: enhanced upper-extremity program, EUEP
arm group type: Experimental
description: Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy.
The EUP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity.
The participants receive 20-day training over a 4-weekperiod. The additional program is designed to be specific to either upper-extremity or lower-extremity.
Accordingly, one group can be used as the control group of the other one.
arm group label: enhanced lower-extremity program,ELLP)
arm group type: Experimental
description: Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy.
The ELP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.
The participants receive 20-day training over a4-weekperiod. The additional program is designed to be specific to either upper-extremity or lower-extremity.
Accordingly,one group can be used as the control group of the other one.
intervention type: Other
intervention name: UFT
description: The EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity,
arm group label: enhanced upper-extremity program, EUEP
intervention type: Other
intervention name: LFT
description: The ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.
arm group label: enhanced lower-extremity program,ELLP)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University WanFang Hospital
investigator full name: Yen-Nung Lin
investigator title: Director of Rehabilitation Department of Taipei Medical University WanFang Hospital
mesh term: Paresis
sharing ipd: No