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/NCT06016660</url>
    </required_header>
    <id_info>
      <org_study_id>EMGHealthy</org_study_id>
      <nct_id>NCT06016660</nct_id>
    </id_info>
    <brief_title>Acute Effect of Resistance Exercise, Neuromuscular Electrical Stimulation, and Transcutaneous Electrical Stimulation Applications on Muscle Activation</brief_title>
    <official_title>Acute Effect of Resistance Exercise, Neuromuscular Electrical Stimulation, and Transcutaneous Electrical Stimulation Applications on Muscle Activation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gazi University</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 aim of our study is to investigate the effects of single-session resistance exercise,&#xD;
        neuromuscular electrical stimulation, and transcutaneous electrical stimulation on the level&#xD;
        of muscle activation and their superiority over each other on both the ipsilateral and&#xD;
        contralateral sides. Our randomized controlled crossover study included 21 participants (13&#xD;
        female, 8 male, age; 27.7±4). Transcutaneous electrical stimulation was used for sensory&#xD;
        input. A single-session application was performed only to the right extremities of all&#xD;
        participants, and the acute effects on muscle activation on both the ipsilateral and&#xD;
        contralateral sides were evaluated. Muscle activation was evaluated with superficial EMG.&#xD;
        SPSS® Statistics V22.0 software was used for statistical analysis. As a result of the&#xD;
        statistical analysis, a significant increase in activation was found only in the sensory&#xD;
        input application group on the ipsilateral side flexor carpi radialis (FCR) (p=0.001), flexor&#xD;
        carpi ulnaris (FCU) (p&lt;0.001), flexor digitorum superficialis (FDS) (p=0.023) and flexor&#xD;
        digitorum profundus (FDP) (p=0.003) muscles. On the contralateral side, there was an increase&#xD;
        in activation in all muscles (FCR; p&lt;0.001, FCU; p=0.033, FDS; p=0.017 and FDP; p=0.001) in&#xD;
        the resistant exercise group. In addition, there was a significant increase in the activation&#xD;
        of certain muscles on the contralateral side in the NMES application group (FCR (p=0.049) and&#xD;
        FDP (p=0.016) muscles) and the sensory input application group (FDP (p=0.004) and FDS&#xD;
        (p=0.043) muscles). In situations where movement is contraindicated, ipsilateral sensory&#xD;
        input can increase the level of muscle activation through both cortical and peripheral neural&#xD;
        mechanisms.In addition, resistance exercise to be performed on the contralateral side can be&#xD;
        an effective application to increase muscle activation on the ipsilateral side.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2022</start_date>
    <completion_date type="Actual">January 1, 2023</completion_date>
    <primary_completion_date type="Actual">October 1, 2022</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Superficial electromyography</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Muscle activation measurement</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">21</enrollment>
    <condition>Motor Activity</condition>
    <arm_group>
      <arm_group_label>Resistance exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Resistance exercise</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Neuromuscular electrical stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Neuromuscular electrical stimulation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Transcutaneous electrical stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Transcutaneous electrical stimulation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physiotherapy</intervention_name>
      <description>Resistance exercise, Neuromuscular electrical stimulation, and Transcutaneous electrical stimulation</description>
      <arm_group_label>Neuromuscular electrical stimulation</arm_group_label>
      <arm_group_label>Resistance exercise</arm_group_label>
      <arm_group_label>Transcutaneous electrical stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • After providing detailed information about the study, individuals who had agreed to&#xD;
          participate in the research were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with any central or peripheral nervous system disease/injury affecting the&#xD;
               upper extremity,&#xD;
  &#xD;
            -  Individuals with a history of orthopedic injury that could impact the study,&#xD;
  &#xD;
            -  Individuals with a history of neuromuscular disease, congenital anomalies, skin&#xD;
               infections, or cognitive impairments,&#xD;
  &#xD;
            -  Individuals with a history of systemic or metabolic diseases that could potentially&#xD;
               affect the study,&#xD;
  &#xD;
            -  Individuals with a body mass index (BMI) above 30 kg/m2.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Barış SEVEN</name>
        <address>
          <city>İzmir</city>
          <state>Çiğli</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gazi University</investigator_affiliation>
      <investigator_full_name>Barış SEVEN</investigator_full_name>
      <investigator_title>Ph.D. research assistant</investigator_title>
    </responsible_party>
    <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/NCT06016660
  org study id: EMGHealthy
  nct id: NCT06016660
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of our study is to investigate the effects of single-session resistance exercise,
        neuromuscular electrical stimulation, and transcutaneous electrical stimulation on the level
        of muscle activation and their superiority over each other on both the ipsilateral and
        contralateral sides. Our randomized controlled crossover study included 21 participants (13
        female, 8 male, age; 27.7±4). Transcutaneous electrical stimulation was used for sensory
        input. A single-session application was performed only to the right extremities of all
        participants, and the acute effects on muscle activation on both the ipsilateral and
        contralateral sides were evaluated. Muscle activation was evaluated with superficial EMG.
        SPSS® Statistics V22.0 software was used for statistical analysis. As a result of the
        statistical analysis, a significant increase in activation was found only in the sensory
        input application group on the ipsilateral side flexor carpi radialis (FCR) (p=0.001), flexor
        carpi ulnaris (FCU) (p<0.001), flexor digitorum superficialis (FDS) (p=0.023) and flexor
        digitorum profundus (FDP) (p=0.003) muscles. On the contralateral side, there was an increase
        in activation in all muscles (FCR; p<0.001, FCU; p=0.033, FDS; p=0.017 and FDP; p=0.001) in
        the resistant exercise group. In addition, there was a significant increase in the activation
        of certain muscles on the contralateral side in the NMES application group (FCR (p=0.049) and
        FDP (p=0.016) muscles) and the sensory input application group (FDP (p=0.004) and FDS
        (p=0.043) muscles). In situations where movement is contraindicated, ipsilateral sensory
        input can increase the level of muscle activation through both cortical and peripheral neural
        mechanisms.In addition, resistance exercise to be performed on the contralateral side can be
        an effective application to increase muscle activation on the ipsilateral side.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Superficial electromyography
  time frame: through study completion, an average of 1 year
  description: Muscle activation measurement
  arm group label: Resistance exercise
  arm group type: Experimental
  description: Resistance exercise
  arm group label: Neuromuscular electrical stimulation
  arm group type: Experimental
  description: Neuromuscular electrical stimulation
  arm group label: Transcutaneous electrical stimulation
  arm group type: Experimental
  description: Transcutaneous electrical stimulation
  arm group label: Control
  arm group type: No Intervention
  description: No intervention
  intervention type: Other
  intervention name: Physiotherapy
  description: Resistance exercise, Neuromuscular electrical stimulation, and Transcutaneous electrical stimulation
  arm group label: Neuromuscular electrical stimulation
  arm group label: Resistance exercise
  arm group label: Transcutaneous electrical stimulation
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Gazi University
  investigator full name: Barış SEVEN
  investigator title: Ph.D. research assistant
  sharing ipd: No