<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20230206057343N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-09</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of dry needling of ankle plantar flexor muscles on neuromodulation, spasticity, and balance in people with MS and stroke.</public_title>
      <acronym>Dry needling به اختصار می شود DN ,و Multiple sclerosis به اختصار می شود MS</acronym>
      <scientific_title>Comparative Effects of Dry Needling of Gastrocnemius -Soleus muscles on Neuromodulation, Spasticity, and Balance in patients with MS (relapsing-remitting) and stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68454</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: The study is a prospective clinical trial, where the subjects are in two different disease groups (multiple sclerosis and stroke), which are non-randomly placed in two groups, and the subjects receive the same intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Multiple Sclerosis (Remitting Relapsing). Condition 2: Stroke.</hc_freetext>
      <i_freetext>Intervention group:  Dry needling will be done on the internal and external head of the gastrocnemius muscle, and the soleus muscle (in the area of the motor point)  by using a 0.30 x 50 mm foliform needle for one minute. For each muscle, dry needling by the fast in fast out method and in a cone shape will be done. Dry needling will be done for three weeks and one session every week..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
If needed by the researchers and their request, the raw data of the research and Its analysis will be provided to researchers

When:
After the publication of the articles resulting from the research

To whom:
Researchers working in academic institutions

Conditions:
The data is only available to other researchers to study and review treatment results Placed

Where to obtain:
By sending an email to the corresponding author

How to obtain:
Send an email to the responsible author and request the document

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nastaran Ghotbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, District 12, Enghelab St، Pich-e-Shemiran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>nghotbi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haniyeh Choobsaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, District 12, Enghelab St، Pich-e-Shemiran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>Choobsaz-h@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Remitting and relapsing Multiple sclerosis disease
Having a stroke
EDSS score less than 4 in the group of MS patients
Follow instructions
Spasticity of plantarflexors is equal to or greater than 1 using (MMAS scale)
No diabetes
Absence of any history of treatment with nerve blockers, or treatment with botulinum toxin A 6 months before entering the study.
No history of attacks in MS patients in the last 8 weeks
Absence of limitation of passive range of motion of more than 10 percent in ankle dorsiflexion compared to the less involved leg (absence of contracture).
Absence of other neurological disorder</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Fear of dry needling
Recurrent stroke during the patient evaluation and intervention program
Occurrence of a new attack in a patient with MS
Contraindications to the use of TMS</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
      <hc_code>G46.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
      <hc_keyword>Cerebellar stroke syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Dry needling will be done on the internal and external head of the gastrocnemius muscle, and the soleus muscle (in the area of the motor point)  by using a 0.30 x 50 mm foliform needle for one minute. For each muscle, dry needling by the fast in fast out method and in a cone shape will be done. Dry needling will be done for three weeks and one session every week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neuromodulation. Timepoint: Before the intervention, After 3 sessions of intervention, and 2 weeks after for follow up. Method of measurement: With Trans-cranial magnetic stimulation parameters, Including motor evoked potential (MEP) amplitude at rest and muscle motor threshold at rest (RMT) and motor evoked potential amplitude ratio in intracortical inhibition protocol (SICI) and motor evoked potential amplitude ratio in intracortical facilitation protocol (ICF).</prim_outcome>
      <prim_outcome>Spasticity. Timepoint: Before the intervention, after 3 sessions of intervention sessions, and two weeks after the last intervention session for follow-up. Method of measurement: Modified Modified Ashworth Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional Balance. Timepoint: Before the intervention, after 3 sessions of intervention sessions, and two weeks after the last intervention session for follow-up. Method of measurement: Timed up and go test and Four Square Step test.</sec_outcome>
      <sec_outcome>Active and Passive ankle dorsiflexion ROM. Timepoint: Before the intervention, after 3 sessions of intervention sessions, and two weeks after the last intervention session for follow-up. Method of measurement: The evaluation will be done using a goniometry.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-06</approval_date>
        <contact_name>Ethics Committee on Research in Nursing and Midwifery Faculty and Faculty of Rehabilitation, Tehran</contact_name>
        <contact_address>Tehran, District 12, Enghelab St، Pich-e-Shemiran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
