xml: <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/NCT06009692</url>
    </required_header>
    <id_info>
      <org_study_id>Umaira Sattar</org_study_id>
      <nct_id>NCT06009692</nct_id>
    </id_info>
    <brief_title>Effects of Neuro-dynamic Mobilization Techniques on Upper Limb Functions in Pronator Teres Syndrome</brief_title>
    <official_title>Effects of Neuro-dynamic Mobilization Techniques on Upper Limb Functions in Pronator Teres Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International 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>
        The study aimed to determine the effects of neuro-dynamic techniques on upper limb motor and&#xD;
        sensory functions and to compare the effects of slider versus tensioner neuro-dynamic&#xD;
        techniques on upper limb motor and sensory functions in pronator teres syndrome. The&#xD;
        neuro-dynamic techniques is not common as a part of conventional therapy in neurological&#xD;
        physical therapy practice so the study aims to compare the effects of both neuro-dynamic&#xD;
        mobilization techniques on pronator teres syndrome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study aimed to determine the effects of neuro-dynamic techniques on upper limb motor and&#xD;
        sensory functions and to compare the effects of slider versus tensioner neuro-dynamic&#xD;
        techniques on upper limb motor and sensory functions in pronator teres syndrome. Pronator&#xD;
        teres syndrome is a rare condition and easily overlooked and mistaken for the more prevalent&#xD;
        carpal tunnel syndrome. The median nerve may also be squeezed between the heads of the&#xD;
        pronator teres muscle in addition to the carpal tunnel. Patients report pain, numbness, or&#xD;
        paresthesia over the lateral 3.5-digit area and anterior forearm, which worsens with forced&#xD;
        pronation. This condition is most common in the dominant hand or sometimes can be associated&#xD;
        with advanced forearm muscle.in our routine clinical practice, The neuro-dynamic techniques&#xD;
        is not that common in neurological physical therapy practice so the effects of neuro&#xD;
        -dynamics with conventional therapy needs to be evaluated for better outcomes in upper limb&#xD;
        functions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">February 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 20, 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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric visual analogue scale (VAS)</measure>
      <time_frame>2 weeks</time_frame>
      <description>Numeric visual analogue scale (VAS) is a self-reported assessment that consists of a line with severe anchors ranging from &quot;no pain&quot; to &quot;intense pain&quot;, which can be vertical or horizontal. Most frequently 10 cm long, this line serves as a continuum of pain severity. High test-retest reliability for the VAS has been recorded (ICC = 0.71-0.99). VAS is regarded as a powerful, therapeutically practical, accurate, and true measure of pain severity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Upper Extremity Functional Scale (UEFS)</measure>
      <time_frame>2 weeks</time_frame>
      <description>Upper Extremity Functional Scale (UEFS) is an 8-item, region-specific questionnaire designed to evaluate diseases of the upper extremities caused by work. The UEFS is a valid, reliable, and responsive tool created to assess how patients with a range of diseases are affected by upper extremity disorders in terms of function. UEFS demonstrate good internal consistency (Cronbach alpha &gt; 0.83).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Jamar hand held dynamometer</measure>
      <time_frame>2 weeks</time_frame>
      <description>Jamar hand held dynamometer is widely used in clinical practice and research as a result of the American Society of Hand Therapists (ASHT) recommendation of it as the gold standard. The ICC for the Jamar dynamometer ranged from .996 to .998 (p&lt; 0.05).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Goniometer</measure>
      <time_frame>2 weeks</time_frame>
      <description>Goniometer is a method for measuring joint range of motion (ROM) that is widely accepted. It uses accurate and reliable measurement tools, especially the universal goniometer. For goniometry, Intraclass Correlation Coefficients (ICC- 3, k) of 0.94 showed excellent intra-ratter reliability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Nottingham sensory assessment Scale</measure>
      <time_frame>2 weeks</time_frame>
      <description>The Nottingham sensory assessment is a standardized scale for assessing sensory assessment in stroke patients. The NSA consists of 20 items and four subscales. The subscales included proprioception, stereognosis, two-point discrimination and tactile feeling. Each subscales item on tactile location on both sides of the body and bilateral simultaneous contact can be graded on the scale of 0-2. The Cronbach's alpha was used to evaluate internal consistency, values over 0.70 indicate Strong internal consistency.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Wolf Motor Function Test</measure>
      <time_frame>2 weeks</time_frame>
      <description>Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks. The original version consisted of 21 item; the widely used version of the WMFT consists of 17 items Composed of 3 parts: Time, Functional ability &amp;Strength. It Includes 15 function-based tasks and 2 strength based tasks Performance time is referred to as WMFT-TIME. Functional ability is referred to as WMFT-FAS. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The WMFT is an instrument with high inter rater reliability, internal consistency, test-retest reliability, and adequate stability.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Pronator Teres Syndrome</condition>
    <arm_group>
      <arm_group_label>Upper Limb Neurodynamics Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Upper limb Neuro-dynamics (Slider/Tensioner Technique) along with Task Oriented Training</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Upper Limb Conventional Therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Stretching, Strengthening exercises along with Task Oriented Training</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Upper limb Neuro-dynamics (Slider/ Tensioner Technique)</intervention_name>
      <description>The experimental group will receive neuro-dynamic mobilization techniques along with task oriented training. Slider versus tensioner technique will be applied according to each patient's need. Session time will be 25-30 minutes. Four series of 10 tensioning movements at a rhythm of ∼6s per cycle and 1 min rest between each series will be performed. After each cycle of 10 repetitions, the position will hold for 10s.</description>
      <arm_group_label>Upper Limb Neurodynamics Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional Therapy for Upper limb</intervention_name>
      <description>Conventional treatment will include therapeutic ultrasound for 4 min, TENS for 10 min. Task oriented training will be designed according to patient's functional outcomes. Sessions will be given for 6 days a week, 25-30 minutes per day.</description>
      <arm_group_label>Upper Limb Conventional Therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with pronator teres syndrome&#xD;
  &#xD;
            -  At least 6 working hours/ day&#xD;
  &#xD;
            -  Positive Tinel's sign at pronator area (Hoffman's sign)&#xD;
  &#xD;
            -  Positive Pronator teres syndrome test&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any previous history of metabolic disease, liver disease/ diabetes&#xD;
  &#xD;
            -  History of previous injuries to the cervical spine including radiculopathies and&#xD;
               myelopathies as well as spinal stenosis and/or spinal disc herniation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Abrish Habib Abbasi, MS-NMPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Abrish Habib Abbasi, MS-NMPT</last_name>
      <phone>03155311799</phone>
      <email>abrish.habib@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Al-Nafees hospital</name>
        <address>
          <city>Islamabad</city>
          <state>Punjab</state>
          <zip>46060</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Abrish Habib Abbasi, MS-NMPT</last_name>
        <phone>03155311799</phone>
        <email>abrish.habib@riphah.edu.pk</email>
      </contact>
      <contact_backup>
        <last_name>Umaira Sattar, MS-NMPT*</last_name>
        <phone>03315473966</phone>
        <email>umairasattar123456@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Upper limb functions</keyword>
    <keyword>Neurodynamics</keyword>
    <keyword>Pronator Teres Syndrome</keyword>
    <keyword>Task Oriented training</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009692
  org study id: Umaira Sattar
  nct id: NCT06009692
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study aimed to determine the effects of neuro-dynamic techniques on upper limb motor and
        sensory functions and to compare the effects of slider versus tensioner neuro-dynamic
        techniques on upper limb motor and sensory functions in pronator teres syndrome. The
        neuro-dynamic techniques is not common as a part of conventional therapy in neurological
        physical therapy practice so the study aims to compare the effects of both neuro-dynamic
        mobilization techniques on pronator teres syndrome.
  The study aimed to determine the effects of neuro-dynamic techniques on upper limb motor and
        sensory functions and to compare the effects of slider versus tensioner neuro-dynamic
        techniques on upper limb motor and sensory functions in pronator teres syndrome. Pronator
        teres syndrome is a rare condition and easily overlooked and mistaken for the more prevalent
        carpal tunnel syndrome. The median nerve may also be squeezed between the heads of the
        pronator teres muscle in addition to the carpal tunnel. Patients report pain, numbness, or
        paresthesia over the lateral 3.5-digit area and anterior forearm, which worsens with forced
        pronation. This condition is most common in the dominant hand or sometimes can be associated
        with advanced forearm muscle.in our routine clinical practice, The neuro-dynamic techniques
        is not that common in neurological physical therapy practice so the effects of neuro
        -dynamics with conventional therapy needs to be evaluated for better outcomes in upper limb
        functions.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Numeric visual analogue scale (VAS)
  time frame: 2 weeks
  description: Numeric visual analogue scale (VAS) is a self-reported assessment that consists of a line with severe anchors ranging from "no pain" to "intense pain", which can be vertical or horizontal. Most frequently 10 cm long, this line serves as a continuum of pain severity. High test-retest reliability for the VAS has been recorded (ICC = 0.71-0.99). VAS is regarded as a powerful, therapeutically practical, accurate, and true measure of pain severity.
  measure: Upper Extremity Functional Scale (UEFS)
  time frame: 2 weeks
  description: Upper Extremity Functional Scale (UEFS) is an 8-item, region-specific questionnaire designed to evaluate diseases of the upper extremities caused by work. The UEFS is a valid, reliable, and responsive tool created to assess how patients with a range of diseases are affected by upper extremity disorders in terms of function. UEFS demonstrate good internal consistency (Cronbach alpha > 0.83).
  measure: Jamar hand held dynamometer
  time frame: 2 weeks
  description: Jamar hand held dynamometer is widely used in clinical practice and research as a result of the American Society of Hand Therapists (ASHT) recommendation of it as the gold standard. The ICC for the Jamar dynamometer ranged from .996 to .998 (p< 0.05).
  measure: Goniometer
  time frame: 2 weeks
  description: Goniometer is a method for measuring joint range of motion (ROM) that is widely accepted. It uses accurate and reliable measurement tools, especially the universal goniometer. For goniometry, Intraclass Correlation Coefficients (ICC- 3, k) of 0.94 showed excellent intra-ratter reliability.
  measure: Nottingham sensory assessment Scale
  time frame: 2 weeks
  description: The Nottingham sensory assessment is a standardized scale for assessing sensory assessment in stroke patients. The NSA consists of 20 items and four subscales. The subscales included proprioception, stereognosis, two-point discrimination and tactile feeling. Each subscales item on tactile location on both sides of the body and bilateral simultaneous contact can be graded on the scale of 0-2. The Cronbach's alpha was used to evaluate internal consistency, values over 0.70 indicate Strong internal consistency.
  measure: Wolf Motor Function Test
  time frame: 2 weeks
  description: Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks. The original version consisted of 21 item; the widely used version of the WMFT consists of 17 items Composed of 3 parts: Time, Functional ability &Strength. It Includes 15 function-based tasks and 2 strength based tasks Performance time is referred to as WMFT-TIME. Functional ability is referred to as WMFT-FAS. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The WMFT is an instrument with high inter rater reliability, internal consistency, test-retest reliability, and adequate stability.
  arm group label: Upper Limb Neurodynamics Group
  arm group type: Experimental
  description: Upper limb Neuro-dynamics (Slider/Tensioner Technique) along with Task Oriented Training
  arm group label: Upper Limb Conventional Therapy
  arm group type: Active Comparator
  description: Stretching, Strengthening exercises along with Task Oriented Training
  intervention type: Other
  intervention name: Upper limb Neuro-dynamics (Slider/ Tensioner Technique)
  description: The experimental group will receive neuro-dynamic mobilization techniques along with task oriented training. Slider versus tensioner technique will be applied according to each patient's need. Session time will be 25-30 minutes. Four series of 10 tensioning movements at a rhythm of ∼6s per cycle and 1 min rest between each series will be performed. After each cycle of 10 repetitions, the position will hold for 10s.
  arm group label: Upper Limb Neurodynamics Group
  intervention type: Other
  intervention name: Conventional Therapy for Upper limb
  description: Conventional treatment will include therapeutic ultrasound for 4 min, TENS for 10 min. Task oriented training will be designed according to patient's functional outcomes. Sessions will be given for 6 days a week, 25-30 minutes per day.
  arm group label: Upper Limb Conventional Therapy
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Abrish Habib Abbasi, MS-NMPT
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Abrish Habib Abbasi, MS-NMPT
  phone: 03155311799
  email: abrish.habib@riphah.edu.pk
  facility: 
  contact: 
  contact backup: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Syndrome
  sharing ipd: No