<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/NCT03762980</url>
  </required_header>
  <id_info>
    <org_study_id>563-011-2016</org_study_id>
    <nct_id>NCT03762980</nct_id>
  </id_info>
  <brief_title>&quot;Bilateral Training in Stroke Patients&quot;</brief_title>
  <official_title>Effect of Bilateral Training for Upper Extremities in Chronic Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shifa International Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shifa International Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study was to evaluate the effects of bilateral training for upper&#xD;
      extremity in stroke patients and to compare these effects between right and left stroke&#xD;
      patients. A Quasi Experimental Study conducted on community stroke survivors. A total of 24&#xD;
      stroke patients were included and divided into Group A (Right hemiplegia) (n=12) and Group B&#xD;
      (Left hemiplegia) (n=12). Chronic stroke patients (&gt;3 months), aged 30-70 years with left or&#xD;
      right sided diagnosed stroke patients were included while patients on medication that could&#xD;
      affect the cognitive functions or with any other cognitive impairments who are not able to&#xD;
      follow commands were excluded. Both groups received the same intervention of with bilateral&#xD;
      arm training involving 5 functional tasks to improve the functional activities of daily&#xD;
      living in upper extremities. Fugl-Meyer Assessment-Upper Extremity Tool (FMA-UE) and&#xD;
      Wolf-Motor Function Test (WMFT) were used to assess as outcome measures.The measurements were&#xD;
      obtained at baseline and after 6th week of training. Data was analyzed using SPSS version 21.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">December 1, 2016</completion_date>
  <primary_completion_date type="Actual">September 1, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wolf Motor Function Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Wolf Motor Function Test (WMFT) was used to assess upper extremity (UE) motor ability through timed and functional tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl Meyer Assessment-upper Extremity</measure>
    <time_frame>6 weeks</time_frame>
    <description>Used to measure upper limb sensorimotor function in stroke patients</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Right hemiplegic patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Left hemiplegic patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bilateral training (BAT)</intervention_name>
    <description>Each group received bilateral training) for upper extremities for 3 days per week for 01 hour/day for up to 6 weeks. Tasks included functional tasks such as stacking cones and cups, positioning the cup upright, throw a ball into basket, carrying a wooden block and buttoning and unbuttoning of shirt with counting. Each task was performed for 10 minutes and had a rest break of 1 minute.</description>
    <arm_group_label>Left hemiplegic patients</arm_group_label>
    <arm_group_label>Right hemiplegic patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  left or right-sided chronic stroke patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cognitive impairment or unable to follow commands&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>April 1, 2019</last_update_submitted>
  <last_update_submitted_qc>April 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shifa International Hospital</investigator_affiliation>
    <investigator_full_name>Humera Ambreen</investigator_full_name>
    <investigator_title>Bilateral training in stroke patients</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT03762980
org study id: 563-011-2016
nct id: NCT03762980
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study was to evaluate the effects of bilateral training for upper
      extremity in stroke patients and to compare these effects between right and left stroke
      patients. A Quasi Experimental Study conducted on community stroke survivors. A total of 24
      stroke patients were included and divided into Group A (Right hemiplegia) (n=12) and Group B
      (Left hemiplegia) (n=12). Chronic stroke patients (>3 months), aged 30-70 years with left or
      right sided diagnosed stroke patients were included while patients on medication that could
      affect the cognitive functions or with any other cognitive impairments who are not able to
      follow commands were excluded. Both groups received the same intervention of with bilateral
      arm training involving 5 functional tasks to improve the functional activities of daily
      living in upper extremities. Fugl-Meyer Assessment-Upper Extremity Tool (FMA-UE) and
      Wolf-Motor Function Test (WMFT) were used to assess as outcome measures.The measurements were
      obtained at baseline and after 6th week of training. Data was analyzed using SPSS version 21.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Wolf Motor Function Test
time frame: 6 weeks
description: The Wolf Motor Function Test (WMFT) was used to assess upper extremity (UE) motor ability through timed and functional tasks
measure: Fugl Meyer Assessment-upper Extremity
time frame: 6 weeks
description: Used to measure upper limb sensorimotor function in stroke patients
arm group label: Right hemiplegic patients
arm group type: Experimental
arm group label: Left hemiplegic patients
arm group type: Experimental
intervention type: Other
intervention name: Bilateral training (BAT)
description: Each group received bilateral training) for upper extremities for 3 days per week for 01 hour/day for up to 6 weeks. Tasks included functional tasks such as stacking cones and cups, positioning the cup upright, throw a ball into basket, carrying a wooden block and buttoning and unbuttoning of shirt with counting. Each task was performed for 10 minutes and had a rest break of 1 minute.
arm group label: Left hemiplegic patients
arm group label: Right hemiplegic patients
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Shifa International Hospital
investigator full name: Humera Ambreen
investigator title: Bilateral training in stroke patients
mesh term: Stroke
sharing ipd: Undecided