<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/NCT02192476</url>
  </required_header>
  <id_info>
    <org_study_id>CTPT</org_study_id>
    <nct_id>NCT02192476</nct_id>
  </id_info>
  <brief_title>Efficacy of CTPT Method in the Treatment of Post Stroke Shoulder Subluxation</brief_title>
  <acronym>CTPT</acronym>
  <official_title>Efficacy of California Tri-pull Taping Method in the Treatment of Post Stroke Shoulder Subluxation- A Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maharishi Markendeswar University (Deemed to be University)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maharishi Markendeswar University (Deemed to be University)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      california tri-pull taping (CTPT) method might be effective in reducing shoulder subluxation,&#xD;
      pain, and improving active flexion range (AFLXN) range of motion, and functional recovery&#xD;
      after stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All the experimental group participants will receive conventional neuro rehabilitation for 45&#xD;
      minutes along with California tri-pull taping on the subluxed extremity. Lead researcher&#xD;
      applied the CTPT method. The tape was applied as following manner.&#xD;
&#xD;
      Before the first intervention day, participants with hair on their shoulder or upper arm were&#xD;
      asked to shave the area. Two types of tape was used, a self-adhesive 1.5&quot; cotton undercover&#xD;
      tape and a 1&quot; rigid strapping tape. Participants placed their affected arm on a supporting&#xD;
      surface to better approximate the humeral head back into the glenoid fossa. The three pieces&#xD;
      of rigid tape were applied to the patient's shoulder on top of the already applied&#xD;
      self-adhesive cotton tape. The first piece (medial) was applied from 1.5&quot; below the deltoid&#xD;
      tuberosity running straight up the middle of the arm to 2&quot; above the top of the glenoid fossa&#xD;
      between the clavicle and the spine of the scapula. The second piece (posterior) was located&#xD;
      from 1.5&quot; below the deltoid tuberosity to 1.5&quot; above the middle of the spine of the scapula.&#xD;
      The medial border of this second piece ran along the acromial process. Last, the third piece&#xD;
      (anterior) was located from 1.5&quot; below the deltoid tuberosity to run around the front of the&#xD;
      humeral head and over the coracoid process, up to 1.5&quot; above the clavicle. The tape will&#xD;
      removed and new tape applied every Monday, Wednesday, and Friday and remained on the patient&#xD;
      for 6 consecutive weeks.&#xD;
&#xD;
      Following the 6 weeks, each patients of both group was individually re-assessed and evaluated&#xD;
      the effect of intervention and parameters were recorded. The recording and measurement&#xD;
      obtained before and after intervention was subjected to statistical analysis and the result&#xD;
      of that interpreted to obtain the significance of study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 1</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>
  </study_design_info>
  <primary_outcome>
    <measure>Digital Vernier caliper.</measure>
    <time_frame>6 month</time_frame>
    <description>Digital Vernier caliper (Aerospace super) is used to measure the accromion- humeral distance in shoulder subluxation patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Universal Goniometer</measure>
    <time_frame>6 month</time_frame>
    <description>Universal Goniometer is used to measure the active shoulder flexion range of motion (AFLXN). The measurement is taken in lying position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer scale (FUG)</measure>
    <time_frame>6 month</time_frame>
    <description>FUG scale was used to measure the upper extremity motor recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS)</measure>
    <time_frame>6 month</time_frame>
    <description>VAS was used to measure the post stroke shoulder subluxation pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Subluxation of Inferior Shoulder</condition>
  <arm_group>
    <arm_group_label>conventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 participants are allotted in this arm and each participants received conventional neuro rehabilitation programme 5 days a week for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 participants allotted in this arm and each participants received California tri-pull taping method along with conventional neuro rehabilitation was given 5 days a week for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional neuro rehabilitation programme</intervention_name>
    <description>All the conventional group subjects were received standardized conventional neuro rehabilitation programme. The conventional neuro rehabilitation treatment includes, active, and passive range of motion exercise, bilateral activation of pectoralis major, activation of latissimus dorsa, activation of the retractors, weight bearing exercise of upper extremity, activation of supraspinatus, reaching activities, grasping, holding and release, and activity of daily living (ADL) activities. Every participant was received conventional neuro rehabilitation for 45 minutes and 5 days a week.</description>
    <arm_group_label>conventional</arm_group_label>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>California tri-pull taping (CTPT)</intervention_name>
    <description>Two types of tape was used, a self-adhesive 1.5&quot; cotton undercover tape and a 1&quot; rigid strapping tape. Participants placed their affected arm on a supporting surface to better approximate the humeral head back into the glenoid fossa. The three pieces of rigid tape were applied to the patient's shoulder on top of the already applied self-adhesive cotton tape.</description>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Acute stroke.&#xD;
&#xD;
          2. A minimum of 5 mm (0.2 in) shoulder subluxation in the involved upper extremity.&#xD;
&#xD;
          3. Mini mental status examination (MMSE) score &gt;23.&#xD;
&#xD;
          4. Age (35-70 yrs.) and of either sex.&#xD;
&#xD;
          5. Brunnstroms stage 1 and 2. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mini mental status examination (MMSE) score &lt;23.&#xD;
&#xD;
          2. Other musculoskeletal disorder of the affected upper extremity.&#xD;
&#xD;
          3. History of trauma to the affected upper extremity.&#xD;
&#xD;
          4. Hyper or hypo sensitivity disorders.&#xD;
&#xD;
          5. Any skin allergy.&#xD;
&#xD;
          6. Brunnstorm's stage 3 and 4.&#xD;
&#xD;
          7. Individual affected from neurological disorder other than stroke.&#xD;
&#xD;
          8. Un-cooperative patients.&#xD;
&#xD;
          9. Individuals with psychosomatic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Senthil P Kumar, PhD</last_name>
    <role>Study Director</role>
    <affiliation>MMIPR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MMIPR</name>
      <address>
        <city>Ambala</city>
        <state>Haryana</state>
        <zip>133207</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maharishi Markendeswar University (Deemed to be University)</investigator_affiliation>
    <investigator_full_name>Subhasish Chatterjee</investigator_full_name>
    <investigator_title>SUBHASISH CHATTERJEE</investigator_title>
  </responsible_party>
  <keyword>Stroke, subluxation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</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/NCT02192476
org study id: CTPT
nct id: NCT02192476
lead sponsor: 
has dmc: Yes
california tri-pull taping (CTPT) method might be effective in reducing shoulder subluxation,
      pain, and improving active flexion range (AFLXN) range of motion, and functional recovery
      after stroke.
All the experimental group participants will receive conventional neuro rehabilitation for 45
      minutes along with California tri-pull taping on the subluxed extremity. Lead researcher
      applied the CTPT method. The tape was applied as following manner.

      Before the first intervention day, participants with hair on their shoulder or upper arm were
      asked to shave the area. Two types of tape was used, a self-adhesive 1.5" cotton undercover
      tape and a 1" rigid strapping tape. Participants placed their affected arm on a supporting
      surface to better approximate the humeral head back into the glenoid fossa. The three pieces
      of rigid tape were applied to the patient's shoulder on top of the already applied
      self-adhesive cotton tape. The first piece (medial) was applied from 1.5" below the deltoid
      tuberosity running straight up the middle of the arm to 2" above the top of the glenoid fossa
      between the clavicle and the spine of the scapula. The second piece (posterior) was located
      from 1.5" below the deltoid tuberosity to 1.5" above the middle of the spine of the scapula.
      The medial border of this second piece ran along the acromial process. Last, the third piece
      (anterior) was located from 1.5" below the deltoid tuberosity to run around the front of the
      humeral head and over the coracoid process, up to 1.5" above the clavicle. The tape will
      removed and new tape applied every Monday, Wednesday, and Friday and remained on the patient
      for 6 consecutive weeks.

      Following the 6 weeks, each patients of both group was individually re-assessed and evaluated
      the effect of intervention and parameters were recorded. The recording and measurement
      obtained before and after intervention was subjected to statistical analysis and the result
      of that interpreted to obtain the significance of study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Digital Vernier caliper.
time frame: 6 month
description: Digital Vernier caliper (Aerospace super) is used to measure the accromion- humeral distance in shoulder subluxation patients.
measure: Universal Goniometer
time frame: 6 month
description: Universal Goniometer is used to measure the active shoulder flexion range of motion (AFLXN). The measurement is taken in lying position.
measure: Fugl-Meyer scale (FUG)
time frame: 6 month
description: FUG scale was used to measure the upper extremity motor recovery.
measure: Visual analogue scale (VAS)
time frame: 6 month
description: VAS was used to measure the post stroke shoulder subluxation pain.
arm group label: conventional
arm group type: Active Comparator
description: 15 participants are allotted in this arm and each participants received conventional neuro rehabilitation programme 5 days a week for 6 weeks.
arm group label: intervention
arm group type: Experimental
description: 15 participants allotted in this arm and each participants received California tri-pull taping method along with conventional neuro rehabilitation was given 5 days a week for 6 weeks
intervention type: Other
intervention name: conventional neuro rehabilitation programme
description: All the conventional group subjects were received standardized conventional neuro rehabilitation programme. The conventional neuro rehabilitation treatment includes, active, and passive range of motion exercise, bilateral activation of pectoralis major, activation of latissimus dorsa, activation of the retractors, weight bearing exercise of upper extremity, activation of supraspinatus, reaching activities, grasping, holding and release, and activity of daily living (ADL) activities. Every participant was received conventional neuro rehabilitation for 45 minutes and 5 days a week.
arm group label: conventional
arm group label: intervention
intervention type: Other
intervention name: California tri-pull taping (CTPT)
description: Two types of tape was used, a self-adhesive 1.5" cotton undercover tape and a 1" rigid strapping tape. Participants placed their affected arm on a supporting surface to better approximate the humeral head back into the glenoid fossa. The three pieces of rigid tape were applied to the patient's shoulder on top of the already applied self-adhesive cotton tape.
arm group label: intervention
criteria: 
gender: All
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: No
last name: Senthil P Kumar, PhD
role: Study Director
affiliation: MMIPR
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Maharishi Markendeswar University (Deemed to be University)
investigator full name: Subhasish Chatterjee
investigator title: SUBHASISH CHATTERJEE
mesh term: Joint Dislocations