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/NCT05985031</url>
    </required_header>
    <id_info>
      <org_study_id>RIVRFSCIP</org_study_id>
      <nct_id>NCT05985031</nct_id>
    </id_info>
    <brief_title>Reciprocal Inhibition Versus Reciprocal Facilitation In Spinal Cord Injury Patients</brief_title>
    <official_title>Does Reciprocal Inhibition, a Rehabilitation Technique, Convert to Reciprocal Facilitation in Patients With Upper Motor Neuron Lesions?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Physical Medicine Rehabilitation Training and Research 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>
        Reciprocal inhibition is a medulla spinalis control mechanism that facilitates motor&#xD;
        activities in healthy people. As the agonist muscle contracts, the antagonist muscle is&#xD;
        inhibited so that the agonist action can take place properly. In the literature, there are&#xD;
        studies showing that in patients with upper motor neuron lesions, this reverses, and&#xD;
        reciprocal facilitation occurs instead of inhibition. However, there is no clear situation in&#xD;
        this regard, there is a need for more methodologically sound studies. Our aim in this study&#xD;
        is to investigate the presence of reciprocal facilitation in patients with spinal cord&#xD;
        lesions (SCL).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Reciprocal inhibition is a spinal segmental control mechanism that facilitates motor&#xD;
        activities in healthy people and is also used in treating spasticity. Considering the current&#xD;
        literature, there are some studies claiming that this is reversed in patients with upper&#xD;
        motor neuron lesions and that there is reciprocal facilitation instead of inhibition.&#xD;
        However, the proposed evidence is not convincing. Our aim in this study was to investigate&#xD;
        the presence of reciprocal facilitation in detail in patients with upper motor neuron&#xD;
        lesions. This study was conducted in five patients with spinal cord lesions and five healthy&#xD;
        individuals. Both the tibialis anterior and soleus muscles of the cases were recorded using&#xD;
        surface and multi-motor unit electromyography (EMG) electrodes. To elicit an H reflex in the&#xD;
        soleus muscle, an electric current was delivered through the popliteal fossa using the&#xD;
        monopolar technique. The Achilles tendon was tapped with the reflex hammer to elicit a T&#xD;
        reflex. Since the H-reflex and T-reflex responses were detected in the tibialis anterior&#xD;
        muscle surface and multi-motor unit EMG recordings, the findings were evaluated as direct&#xD;
        stimulation, cross-talk, and reciprocal facilitation. Methodologically, This research aimed&#xD;
        to be a guiding study for future studies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 5, 2023</start_date>
    <completion_date type="Actual">August 1, 2023</completion_date>
    <primary_completion_date type="Actual">January 17, 2023</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>Parallel Assignment</intervention_model>
      <intervention_model_description>Group I. Spinal cord injuries Group II. Healthy Control</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reciprocal Inhibition</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>H reflex and T reflex tests were performed in the soleus and tibialis anterior muscle, and it was evaluated whether there was reciprocal inhibition in the tibialis anterior muscle.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>H-reflex</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Electric current was delivered through the popliteal fossa to tibial nerve for eliciting the soleus H-reflex</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>T-reflex</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>The Achilles tendon was hit with using a reflex hammer to elicit the soleus T-reflex.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <arm_group>
      <arm_group_label>Spinal cord injuries</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This was the patient group. Achilles tendon hits were performed for eliciting the soleus T reflex while the ankle was in neutral, dorsiflexion, and plantar flexion. Surface and multi-unit EMG recordings were taken from the anterior and soles muscles of the tibialis during the tendon tapping.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This was the healthy control group. Achilles tendon hits were performed for eliciting the soleus T reflex while the ankle was in neutral, dorsiflexion, and plantar flexion. Surface and multi-unit EMG recordings were taken from the anterior and soles muscles of the tibialis during the tendon tapping.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Tendon tap</intervention_name>
      <description>While examining the T reflex, the ankle was held passively in neutral, dorsiflexion and plantar flexion positions by the investigator.</description>
      <arm_group_label>Healthy Control</arm_group_label>
      <arm_group_label>Spinal cord injuries</arm_group_label>
      <other_name>T-reflex</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Tibial nerve stimulation</intervention_name>
      <description>H-reflex responses were examined by tibial nerve stimulation</description>
      <arm_group_label>Healthy Control</arm_group_label>
      <arm_group_label>Spinal cord injuries</arm_group_label>
      <other_name>H-reflex</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with spinal cord injury between the ages of 18-60&#xD;
  &#xD;
            -  A minimum of 6 months of SCL history&#xD;
  &#xD;
            -  Soleus spasticity&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with premorbid neuromuscular disease&#xD;
  &#xD;
            -  History of autonomic dysreflexia&#xD;
  &#xD;
            -  Patients in the spinal shock period&#xD;
  &#xD;
            -  Those who have a coronavirus disease clinic&#xD;
  &#xD;
            -  Less than 2 hours sitting tolerance&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>İLHAN KARACAN, MD, Prof</last_name>
      <role>Study Director</role>
      <affiliation>İstanbul Physical Therapy Rehabilitation Training &amp; Research Hosptial</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>İstanbul Physical Therapy Training and Research Hospital</name>
        <address>
          <city>Istanbul</city>
          <zip>34180</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Mustafa Kökçe</investigator_full_name>
      <investigator_title>assistant doctor</investigator_title>
    </responsible_party>
    <keyword>Spinal Cord</keyword>
    <keyword>motor neuron</keyword>
    <keyword>Spasticity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
    </condition_browse>
    <!-- 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/NCT05985031
  org study id: RIVRFSCIP
  nct id: NCT05985031
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Reciprocal inhibition is a medulla spinalis control mechanism that facilitates motor
        activities in healthy people. As the agonist muscle contracts, the antagonist muscle is
        inhibited so that the agonist action can take place properly. In the literature, there are
        studies showing that in patients with upper motor neuron lesions, this reverses, and
        reciprocal facilitation occurs instead of inhibition. However, there is no clear situation in
        this regard, there is a need for more methodologically sound studies. Our aim in this study
        is to investigate the presence of reciprocal facilitation in patients with spinal cord
        lesions (SCL).
  Reciprocal inhibition is a spinal segmental control mechanism that facilitates motor
        activities in healthy people and is also used in treating spasticity. Considering the current
        literature, there are some studies claiming that this is reversed in patients with upper
        motor neuron lesions and that there is reciprocal facilitation instead of inhibition.
        However, the proposed evidence is not convincing. Our aim in this study was to investigate
        the presence of reciprocal facilitation in detail in patients with upper motor neuron
        lesions. This study was conducted in five patients with spinal cord lesions and five healthy
        individuals. Both the tibialis anterior and soleus muscles of the cases were recorded using
        surface and multi-motor unit electromyography (EMG) electrodes. To elicit an H reflex in the
        soleus muscle, an electric current was delivered through the popliteal fossa using the
        monopolar technique. The Achilles tendon was tapped with the reflex hammer to elicit a T
        reflex. Since the H-reflex and T-reflex responses were detected in the tibialis anterior
        muscle surface and multi-motor unit EMG recordings, the findings were evaluated as direct
        stimulation, cross-talk, and reciprocal facilitation. Methodologically, This research aimed
        to be a guiding study for future studies.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Group I. Spinal cord injuries Group II. Healthy Control
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Reciprocal Inhibition
  time frame: up to 2 weeks
  description: H reflex and T reflex tests were performed in the soleus and tibialis anterior muscle, and it was evaluated whether there was reciprocal inhibition in the tibialis anterior muscle.
  measure: H-reflex
  time frame: up to 2 weeks
  description: Electric current was delivered through the popliteal fossa to tibial nerve for eliciting the soleus H-reflex
  measure: T-reflex
  time frame: up to 2 weeks
  description: The Achilles tendon was hit with using a reflex hammer to elicit the soleus T-reflex.
  arm group label: Spinal cord injuries
  arm group type: Experimental
  description: This was the patient group. Achilles tendon hits were performed for eliciting the soleus T reflex while the ankle was in neutral, dorsiflexion, and plantar flexion. Surface and multi-unit EMG recordings were taken from the anterior and soles muscles of the tibialis during the tendon tapping.
  arm group label: Healthy Control
  arm group type: Active Comparator
  description: This was the healthy control group. Achilles tendon hits were performed for eliciting the soleus T reflex while the ankle was in neutral, dorsiflexion, and plantar flexion. Surface and multi-unit EMG recordings were taken from the anterior and soles muscles of the tibialis during the tendon tapping.
  intervention type: Diagnostic Test
  intervention name: Tendon tap
  description: While examining the T reflex, the ankle was held passively in neutral, dorsiflexion and plantar flexion positions by the investigator.
  arm group label: Healthy Control
  arm group label: Spinal cord injuries
  other name: T-reflex
  intervention type: Diagnostic Test
  intervention name: Tibial nerve stimulation
  description: H-reflex responses were examined by tibial nerve stimulation
  arm group label: Healthy Control
  arm group label: Spinal cord injuries
  other name: H-reflex
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: İLHAN KARACAN, MD, Prof
  role: Study Director
  affiliation: İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
  investigator full name: Mustafa Kökçe
  investigator title: assistant doctor
  mesh term: Spinal Cord Injuries