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/NCT06017960</url>
    </required_header>
    <id_info>
      <org_study_id>EMGUS-DN</org_study_id>
      <nct_id>NCT06017960</nct_id>
    </id_info>
    <brief_title>Effects of Dry Needling on Electromyographic Activity and Ultrasonographic Characteristics in Post-Stroke Spasticity</brief_title>
    <official_title>Effects of Dry Needling on Electromyographic Activity and Ultrasonographic Characteristics in Post-Stroke Spasticity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad de Zaragoza</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Alcala</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universidad de Zaragoza</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>
        Stroke is a global health problem, with an incidence in Europe of 147/100,000 people per&#xD;
        year. It is estimated that 43% of them present spasticity throughout the first year, causing&#xD;
        disability, hindering mobility and functionality, which can generate comorbidity problems,&#xD;
        which in turn hinders its improvement over time.&#xD;
  &#xD;
        Recently, high quality studies have conclude that there is a moderate level of evidence with&#xD;
        large effect size in reducing spasticity with dry needling, as well as being cost-effective&#xD;
        in stroke patients in both the subacute and chronic phases. However, due to the limitation of&#xD;
        manual evaluations of spasticity, and it is necessary to look for measurement alternatives&#xD;
        that complement it, such as the analysis of the electromyographic activity and the muscular&#xD;
        structure measured with ultrasound. These data could provide objective, useful and&#xD;
        complementary information to clinical assessments to be more specific and effective in the&#xD;
        treatment of stroke patients.&#xD;
  &#xD;
        This randomized controlled trial aim to analyse the effect of dry needling in this parameters&#xD;
        in patients with stroke and spasticity, as well as correlated with gait variables. Each&#xD;
        participant will be randomly assigned to the dry needling group or to the sham dry needling&#xD;
        group, where participants receive a total of 4 sessions of ultrasound-guided dry needling or&#xD;
        sham ultrasound-guided dry needling in the gastrocnemius medialis over 4 weeks, one per week.&#xD;
        Measures of spasticity, electromyographic activity and muscle structure via ultrasound will&#xD;
        made at baseline (T0) and immediate after each intervention (T1,T2,T3,T4). Gait variables&#xD;
        will be made at baseline and after the last intervention (T0 and T4).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of the study is to analyse the effect of dry needling in stroke patients. The&#xD;
        investigators hypothesized dry needling will decrease spasticity and electromyographic&#xD;
        activity of spastic muscles during dynamic stretching and at rest, causing a reduction of&#xD;
        their abnormal hyperactivity.&#xD;
  &#xD;
        Secondary, dry needling will also improve the maximum muscle contraction capacity; will&#xD;
        improve spastic muscle ultrasound variables in terms of decreased muscle thickness and&#xD;
        pennation angle, increased fasciculus length and reduced pixel intensity measured via&#xD;
        histogram and second order histogram parameters; as well as dry needling will improve gait&#xD;
        parameters such as gait speed, functional gait and better spatiotemporal parameters such as a&#xD;
        reduction of the variability, asymmetry and an improve of the stride length.&#xD;
  &#xD;
        On the other hand, the investigators hypothesized that there is a correlation between the&#xD;
        changes that will be found in the electromyographic activity, the ultrasound variables, and&#xD;
        the clinical and gait variables. This information will allow us to make useful predictions of&#xD;
        best responders to dry needling according to the information obtained in electromyographic&#xD;
        and ultrasound explorations.&#xD;
  &#xD;
        The study will be a randomized clinical trial with a control group. Each participant will be&#xD;
        randomly assigned to the dry needling group or to the sham dry needling group with a 1:1&#xD;
        ratio, where they will receive a total of 4 sessions of ultrasound-guided dry needling or&#xD;
        sham ultrasound-guided dry needling in the gastrocnemius medialis over 4 weeks, one per week.&#xD;
  &#xD;
        After being informed about the study, all eligible patients give their written informed&#xD;
        consent.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2025</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>
      <intervention_model_description>Randomized controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Allocation conceal will be performed using a computer-generated randomized table of numbers created before data collection. Both participants, evaluator and data analyzer will be blinded to the type of intervention.&#xD;
  To take the ultrasound images, an artificial arm will be used to hold the probe and to avoid direct contact by the researcher. Another researcher will analyze the images through a program. Both participants, image analyzer and data analyzer will be blinded to the type of intervention</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Modified Ashworth Scale</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>The modified Ashworth scale (MAS) will be the main outcome of the investigation, as is one of the most studied scales in the application of dry needling in patients with spasticity in stroke population. The MAS is indicated to assess spasticity, or positive speed-dependent stretching reflex, in pathologies of the central nervous system.&#xD;
  The scale rate muscle tone on a scale between 0 and 4. 0 is no increase in tone, 1 slight increase in tone and catch/release at end of Range Of Motion (ROM), 1+ with catch/release through 1/2 ROM, 2 more marked increased in tone through ROM, but affected part moved easily, 3 considerable increase in tone, passive movement difficult, 4 affected part rigid flexion or extension.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>surface Electromyography (sEMG) - Activity at rest</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>The first test will evaluate the muscle activity at rest, while the subject is asked to be relaxed, the Root Mean Square (RMS) of both inner gastrocnemius will be measured for 30 seconds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sEMG - Dynamic stretching</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>The second measurement will consist of a dynamic stretch to assess muscular activity during the speed-dependent stretching reflex or spasticity. For this, 10 passive stretches will be performed according to the method described and validated by Marinelli et al. 2013, that showed an easily reproducible constant speed and rhythm to avoid intra-rater bias along the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sEMG - Maximum Voluntary Isometric Contraction</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>The third test will consist of evaluating the Maximum Voluntary Isometric Contraction (MVIC) of the internal gastrocnemius muscle. To do this, the ankle will be placed in an intermediate position, with neither fully elongated nor fully shortened muscle fibers, and 5 seconds of maximum isometric contraction towards plantar flexion will be performed 3 times, leaving an interval of 60 seconds between repetitions. Then the maximum values of electromyographic activation of each repetition will be selected to obtain the mean value.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ultrasound (US) - Muscle thickness</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>Muscle thickness is the distance between deep and superficial aponeurosis of a muscle, from an image of the gastrocnemius medialis obtained with ultrasound.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>US - Pennation angle</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>The pennation angle is defined as the angle formed by the muscle fasciculus with the deep aponeurosis, from an image of the gastrocnemius medialis obtained with ultrasound.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>US - Fascicle length</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>Fascicle length is the length of the fascicular path between the insertions of the fascicle into the superficial and deep aponeuroses, from an image of the gastrocnemius medialis obtained with ultrasound.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>US - Histogram/Echo intensity</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>Echo intensity was defined as the brightness of the image acquired through ultrasound. It is expressed in gray scale between 0 and 255 after processing the image in an image analysis software, from an image of the gastrocnemius medialis obtained with ultrasound.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>US - Grey level co-occurrence matrices (GLCM)</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>Grey level co-occurrence matrices (GLCM) consist of comparing pair of pixels separated by a certain distance (by default a value of 1 is used) and in an angular direction (0°, 45°, 90°, and 135°) along the entire matrix, calculating the frequency with which certain grey levels appear in the image and their relationship with each other, from an image of the gastrocnemius medialis obtained with ultrasound.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>US - Run-length matrices (GLRLM)</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>Run-length matrices (GLRLM) represents a set of consecutive pixels having the same grey level in each of the four angular directions described across the entire matrix, from an image of the gastrocnemius medialis obtained with ultrasound.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>US - Local binary pattern (LBP)</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>Local binary pattern (LBP) analysis compares the intensity of a central pixel, which is taken as a reference value, with the surrounding pixels, from an image of the gastrocnemius medialis obtained with ultrasound.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>US - Blob analysis (BA)</measure>
      <time_frame>Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).</time_frame>
      <description>Blob analysis is based on detecting areas close to each other with a similar eco-intensity called &quot;blobs&quot;, from an image of the gastrocnemius medialis obtained with ultrasound.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Timed Up and Go (TUG)</measure>
      <time_frame>Baseline (T0) and after the fourth intervention in fourth week (T4).</time_frame>
      <description>The Timed Up and Go (TUG) test to assess functional gait, which consists of measuring the seconds it takes the individual to get up from a chair approximately 46 centimeters high, travel 3 meters, turn and sit again. This scale has showed excellent intrarater reliability (ICC&gt;0.95) in patients with stroke.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>10 Meter Walking Test (10MWT)</measure>
      <time_frame>Baseline (T0) and after the fourth intervention in fourth week (T4).</time_frame>
      <description>The 10 Meter Walking Test (10MWT) to assess the comfortable and fast speed of the march, which consists of measuring the seconds that the subject takes to travel 10 meters in a straight line to obtain the comfortable and fast speed in meters per second (m/s), with excellent intrarater reliability (ICC=0.87-0.88).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6 Minute Walking Test (6MWT)</measure>
      <time_frame>Baseline (T0) and after the fourth intervention in fourth week (T4).</time_frame>
      <description>The 6 Minute Walking Test (6MWT) to assess the resistance and distance in meters that the subject travels for 6 minutes, showing good intrarater reliability (ICC=0.74), in patients with stroke.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gait variability</measure>
      <time_frame>Baseline (T0) and after the fourth intervention in fourth week (T4).</time_frame>
      <description>The variability represents the coefficient of variation of cycle duration in percent (%) measured with a validated tool for spatiotemporal gait analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gait asymmetry</measure>
      <time_frame>Baseline (T0) and after the fourth intervention in fourth week (T4).</time_frame>
      <description>The asymmetry is the ratio of swing times, which compares the time in the air of each foot in percent (%) measured with a validated tool for spatiotemporal gait analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Affected leg stride length</measure>
      <time_frame>Baseline (T0) and after the fourth intervention in fourth week (T4).</time_frame>
      <description>The stride length describes the distance between two successive footprints on the ground, from the heel of a foot to the heel on the same foot, one cycle after, measured with a validated tool for spatiotemporal gait analysis. Both affected and non affected leg stride length will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-affected leg stride length</measure>
      <time_frame>Baseline (T0) and after the fourth intervention in fourth week (T4).</time_frame>
      <description>The stride length describes the distance between two successive footprints on the ground, from the heel of a foot to the heel on the same foot, one cycle after, measured with a validated tool for spatiotemporal gait analysis. Both affected and non affected leg stride length will be measured.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Spasticity as Sequela of Stroke</condition>
    <arm_group>
      <arm_group_label>Dry needling group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dry needling + usual care. Subjects will receive a total of 4 sessions of ultrasound-guided dry needling over 4 weeks, one per week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Sham or simulated dry needling. + usual care. Subjects will receive a total of 4 sessions of sham ultrasound-guided dry needling over 4 weeks, one per week.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dry needling + usual care</intervention_name>
      <description>Participants assigned to the dry needling group will receive a weekly session for four weeks of ultrasound-guided dry needling in the inner gastrocnemius muscle with disposable stainless-steel needles, according to the depth of the muscle to be treated. For the realization of the technique, the diagnostic criteria of the Dry Needling in Hypertonia and Spasticity technique (DNHS®) developed by Herrero et al. will be applied adapted to the characteristics of the study, as well as the procedure for its application.&#xD;
  The ultrasound guidance will be the same ultrasound device than in the assessments. This ultrasound-guided intervention allows to guarantee the safety of the approach, to have the certainty in the location of the target structure and to see the responses of local spasm. During the application of the technique, patient will not look at the ultrasound screen to ensure the blindness of the patient to the group allocated.</description>
      <arm_group_label>Dry needling group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sham dry needling + usual care</intervention_name>
      <description>Participants assigned to this group will receive the same assessments, the same number of sessions, and the sham dry needling at the same site as the dry needling group, but with a sham intervention, where the needle is dropped through the guide tube and touch the skin. The patient will not feel anything, or at most that the needle touches the skin, since it does not get into the subcutaneous cell tissue, as placebo interventions were performed in similar studies. The context will be simulated in its entirety, using the same ultrasound and disposable needles for the intervention.&#xD;
  Both groups will continue their daily motor rehabilitation treatment during the 4 weeks, which consists of strength training, balance, motor control, gait training, and mass practice oriented to tasks of intensity and duration appropriate to each patient, allowing the fastest possible clinical improvement, as recommended by clinical practice guidelines.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  be over 18 years old&#xD;
  &#xD;
            -  understand and voluntarily sign informed consent before performing the intervention&#xD;
  &#xD;
            -  have a medical diagnosis of ischemic or hemorrhagic stroke&#xD;
  &#xD;
            -  have a grade between 1-3 according to the modified Ashworth scale (MAS) on the triceps&#xD;
               sural&#xD;
  &#xD;
            -  able to walk independently to perform gait test&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  recurrent stroke&#xD;
  &#xD;
            -  who have received previous treatments of botulinum toxin type A in the last 3 months&#xD;
  &#xD;
            -  who have received treatments with dry needling in the last month&#xD;
  &#xD;
            -  severe cognitive deficits&#xD;
  &#xD;
            -  fear of needles&#xD;
  &#xD;
            -  metal allergy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Pablo Herrero Gallego, PhD</last_name>
      <phone>646168248</phone>
      <email>pherrero@unizar.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centro Europeo de Neurociencias</name>
        <address>
          <city>Madrid</city>
          <zip>28023</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Daniel Jiménez Masa</last_name>
      </contact>
      <investigator>
        <last_name>Daniel Jiménez Masa, PT, PhD(c)</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Javier Sánchez Aguilar, PT</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 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>Universidad de Zaragoza</investigator_affiliation>
      <investigator_full_name>Dr. Pablo Herrero Gallego</investigator_full_name>
      <investigator_title>PhD</investigator_title>
    </responsible_party>
    <keyword>Dry needling</keyword>
    <keyword>Spasticity</keyword>
    <keyword>Hypertonia</keyword>
    <keyword>Surface electromyography</keyword>
    <keyword>Diagnostic ultrasound</keyword>
    <keyword>Gait</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscle Spasticity</mesh_term>
      <mesh_term>Stroke</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/NCT06017960
  org study id: EMGUS-DN
  nct id: NCT06017960
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Stroke is a global health problem, with an incidence in Europe of 147/100,000 people per
        year. It is estimated that 43% of them present spasticity throughout the first year, causing
        disability, hindering mobility and functionality, which can generate comorbidity problems,
        which in turn hinders its improvement over time.
  
        Recently, high quality studies have conclude that there is a moderate level of evidence with
        large effect size in reducing spasticity with dry needling, as well as being cost-effective
        in stroke patients in both the subacute and chronic phases. However, due to the limitation of
        manual evaluations of spasticity, and it is necessary to look for measurement alternatives
        that complement it, such as the analysis of the electromyographic activity and the muscular
        structure measured with ultrasound. These data could provide objective, useful and
        complementary information to clinical assessments to be more specific and effective in the
        treatment of stroke patients.
  
        This randomized controlled trial aim to analyse the effect of dry needling in this parameters
        in patients with stroke and spasticity, as well as correlated with gait variables. Each
        participant will be randomly assigned to the dry needling group or to the sham dry needling
        group, where participants receive a total of 4 sessions of ultrasound-guided dry needling or
        sham ultrasound-guided dry needling in the gastrocnemius medialis over 4 weeks, one per week.
        Measures of spasticity, electromyographic activity and muscle structure via ultrasound will
        made at baseline (T0) and immediate after each intervention (T1,T2,T3,T4). Gait variables
        will be made at baseline and after the last intervention (T0 and T4).
  The aim of the study is to analyse the effect of dry needling in stroke patients. The
        investigators hypothesized dry needling will decrease spasticity and electromyographic
        activity of spastic muscles during dynamic stretching and at rest, causing a reduction of
        their abnormal hyperactivity.
  
        Secondary, dry needling will also improve the maximum muscle contraction capacity; will
        improve spastic muscle ultrasound variables in terms of decreased muscle thickness and
        pennation angle, increased fasciculus length and reduced pixel intensity measured via
        histogram and second order histogram parameters; as well as dry needling will improve gait
        parameters such as gait speed, functional gait and better spatiotemporal parameters such as a
        reduction of the variability, asymmetry and an improve of the stride length.
  
        On the other hand, the investigators hypothesized that there is a correlation between the
        changes that will be found in the electromyographic activity, the ultrasound variables, and
        the clinical and gait variables. This information will allow us to make useful predictions of
        best responders to dry needling according to the information obtained in electromyographic
        and ultrasound explorations.
  
        The study will be a randomized clinical trial with a control group. Each participant will be
        randomly assigned to the dry needling group or to the sham dry needling group with a 1:1
        ratio, where they will receive a total of 4 sessions of ultrasound-guided dry needling or
        sham ultrasound-guided dry needling in the gastrocnemius medialis over 4 weeks, one per week.
  
        After being informed about the study, all eligible patients give their written informed
        consent.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Allocation conceal will be performed using a computer-generated randomized table of numbers created before data collection. Both participants, evaluator and data analyzer will be blinded to the type of intervention.
  To take the ultrasound images, an artificial arm will be used to hold the probe and to avoid direct contact by the researcher. Another researcher will analyze the images through a program. Both participants, image analyzer and data analyzer will be blinded to the type of intervention
  measure: Modified Ashworth Scale
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: The modified Ashworth scale (MAS) will be the main outcome of the investigation, as is one of the most studied scales in the application of dry needling in patients with spasticity in stroke population. The MAS is indicated to assess spasticity, or positive speed-dependent stretching reflex, in pathologies of the central nervous system.
  The scale rate muscle tone on a scale between 0 and 4. 0 is no increase in tone, 1 slight increase in tone and catch/release at end of Range Of Motion (ROM), 1+ with catch/release through 1/2 ROM, 2 more marked increased in tone through ROM, but affected part moved easily, 3 considerable increase in tone, passive movement difficult, 4 affected part rigid flexion or extension.
  measure: surface Electromyography (sEMG) - Activity at rest
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: The first test will evaluate the muscle activity at rest, while the subject is asked to be relaxed, the Root Mean Square (RMS) of both inner gastrocnemius will be measured for 30 seconds.
  measure: sEMG - Dynamic stretching
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: The second measurement will consist of a dynamic stretch to assess muscular activity during the speed-dependent stretching reflex or spasticity. For this, 10 passive stretches will be performed according to the method described and validated by Marinelli et al. 2013, that showed an easily reproducible constant speed and rhythm to avoid intra-rater bias along the study.
  measure: sEMG - Maximum Voluntary Isometric Contraction
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: The third test will consist of evaluating the Maximum Voluntary Isometric Contraction (MVIC) of the internal gastrocnemius muscle. To do this, the ankle will be placed in an intermediate position, with neither fully elongated nor fully shortened muscle fibers, and 5 seconds of maximum isometric contraction towards plantar flexion will be performed 3 times, leaving an interval of 60 seconds between repetitions. Then the maximum values of electromyographic activation of each repetition will be selected to obtain the mean value.
  measure: Ultrasound (US) - Muscle thickness
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: Muscle thickness is the distance between deep and superficial aponeurosis of a muscle, from an image of the gastrocnemius medialis obtained with ultrasound.
  measure: US - Pennation angle
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: The pennation angle is defined as the angle formed by the muscle fasciculus with the deep aponeurosis, from an image of the gastrocnemius medialis obtained with ultrasound.
  measure: US - Fascicle length
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: Fascicle length is the length of the fascicular path between the insertions of the fascicle into the superficial and deep aponeuroses, from an image of the gastrocnemius medialis obtained with ultrasound.
  measure: US - Histogram/Echo intensity
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: Echo intensity was defined as the brightness of the image acquired through ultrasound. It is expressed in gray scale between 0 and 255 after processing the image in an image analysis software, from an image of the gastrocnemius medialis obtained with ultrasound.
  measure: US - Grey level co-occurrence matrices (GLCM)
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: Grey level co-occurrence matrices (GLCM) consist of comparing pair of pixels separated by a certain distance (by default a value of 1 is used) and in an angular direction (0°, 45°, 90°, and 135°) along the entire matrix, calculating the frequency with which certain grey levels appear in the image and their relationship with each other, from an image of the gastrocnemius medialis obtained with ultrasound.
  measure: US - Run-length matrices (GLRLM)
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: Run-length matrices (GLRLM) represents a set of consecutive pixels having the same grey level in each of the four angular directions described across the entire matrix, from an image of the gastrocnemius medialis obtained with ultrasound.
  measure: US - Local binary pattern (LBP)
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: Local binary pattern (LBP) analysis compares the intensity of a central pixel, which is taken as a reference value, with the surrounding pixels, from an image of the gastrocnemius medialis obtained with ultrasound.
  measure: US - Blob analysis (BA)
  time frame: Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).
  description: Blob analysis is based on detecting areas close to each other with a similar eco-intensity called "blobs", from an image of the gastrocnemius medialis obtained with ultrasound.
  measure: Timed Up and Go (TUG)
  time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
  description: The Timed Up and Go (TUG) test to assess functional gait, which consists of measuring the seconds it takes the individual to get up from a chair approximately 46 centimeters high, travel 3 meters, turn and sit again. This scale has showed excellent intrarater reliability (ICC>0.95) in patients with stroke.
  measure: 10 Meter Walking Test (10MWT)
  time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
  description: The 10 Meter Walking Test (10MWT) to assess the comfortable and fast speed of the march, which consists of measuring the seconds that the subject takes to travel 10 meters in a straight line to obtain the comfortable and fast speed in meters per second (m/s), with excellent intrarater reliability (ICC=0.87-0.88).
  measure: 6 Minute Walking Test (6MWT)
  time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
  description: The 6 Minute Walking Test (6MWT) to assess the resistance and distance in meters that the subject travels for 6 minutes, showing good intrarater reliability (ICC=0.74), in patients with stroke.
  measure: Gait variability
  time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
  description: The variability represents the coefficient of variation of cycle duration in percent (%) measured with a validated tool for spatiotemporal gait analysis
  measure: Gait asymmetry
  time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
  description: The asymmetry is the ratio of swing times, which compares the time in the air of each foot in percent (%) measured with a validated tool for spatiotemporal gait analysis.
  measure: Affected leg stride length
  time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
  description: The stride length describes the distance between two successive footprints on the ground, from the heel of a foot to the heel on the same foot, one cycle after, measured with a validated tool for spatiotemporal gait analysis. Both affected and non affected leg stride length will be measured.
  measure: Non-affected leg stride length
  time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).
  description: The stride length describes the distance between two successive footprints on the ground, from the heel of a foot to the heel on the same foot, one cycle after, measured with a validated tool for spatiotemporal gait analysis. Both affected and non affected leg stride length will be measured.
  arm group label: Dry needling group
  arm group type: Experimental
  description: Dry needling + usual care. Subjects will receive a total of 4 sessions of ultrasound-guided dry needling over 4 weeks, one per week.
  arm group label: Control group
  arm group type: Sham Comparator
  description: Sham or simulated dry needling. + usual care. Subjects will receive a total of 4 sessions of sham ultrasound-guided dry needling over 4 weeks, one per week.
  intervention type: Other
  intervention name: Dry needling + usual care
  description: Participants assigned to the dry needling group will receive a weekly session for four weeks of ultrasound-guided dry needling in the inner gastrocnemius muscle with disposable stainless-steel needles, according to the depth of the muscle to be treated. For the realization of the technique, the diagnostic criteria of the Dry Needling in Hypertonia and Spasticity technique (DNHS®) developed by Herrero et al. will be applied adapted to the characteristics of the study, as well as the procedure for its application.
  The ultrasound guidance will be the same ultrasound device than in the assessments. This ultrasound-guided intervention allows to guarantee the safety of the approach, to have the certainty in the location of the target structure and to see the responses of local spasm. During the application of the technique, patient will not look at the ultrasound screen to ensure the blindness of the patient to the group allocated.
  arm group label: Dry needling group
  intervention type: Other
  intervention name: Sham dry needling + usual care
  description: Participants assigned to this group will receive the same assessments, the same number of sessions, and the sham dry needling at the same site as the dry needling group, but with a sham intervention, where the needle is dropped through the guide tube and touch the skin. The patient will not feel anything, or at most that the needle touches the skin, since it does not get into the subcutaneous cell tissue, as placebo interventions were performed in similar studies. The context will be simulated in its entirety, using the same ultrasound and disposable needles for the intervention.
  Both groups will continue their daily motor rehabilitation treatment during the 4 weeks, which consists of strength training, balance, motor control, gait training, and mass practice oriented to tasks of intensity and duration appropriate to each patient, allowing the fastest possible clinical improvement, as recommended by clinical practice guidelines.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Pablo Herrero Gallego, PhD
  phone: 646168248
  email: pherrero@unizar.es
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: Spain
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  PMID: 30256006
  citation: Kabboord AD, Van Eijk M, Buijck BI, Koopmans RTCM, van Balen R, Achterberg WP. Comorbidity and intercurrent diseases in geriatric stroke rehabilitation: a multicentre observational study in skilled nursing facilities. Eur Geriatr Med. 2018;9(3):347-353. doi: 10.1007/s41999-018-0043-5. Epub 2018 Mar 13.
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  citation: Li S, Francisco GE, Rymer WZ. A New Definition of Poststroke Spasticity and the Interference of Spasticity With Motor Recovery From Acute to Chronic Stages. Neurorehabil Neural Repair. 2021 Jul;35(7):601-610. doi: 10.1177/15459683211011214. Epub 2021 May 12.
  PMID: 33978513
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  PMID: 34894776
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  responsible party type: Principal Investigator
  investigator affiliation: Universidad de Zaragoza
  investigator full name: Dr. Pablo Herrero Gallego
  investigator title: PhD
  mesh term: Muscle Spasticity
  mesh term: Stroke
  sharing ipd: No