<?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>IRCT20210622051667N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-30</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of  combined speech and music-therapy on the  vocal characteristics of people with Parkinson's disease</public_title>
      <acronym></acronym>
      <scientific_title>comparison of The effect of  speech therapy , music-therapy and combined speech and music therapy on the  vocal characteristics of people with Parkinson's disease by using telerehabilitation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57048</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using SPSS software for numbers from 1 to 33, we produce three groups with 11 numbers from zero, one or two. By balloting, the speech therapy group was assigned number zero, the combination therapy group number one and the music therapy group number two.To hide the created list, all the mentioned steps are done by someone who does not do the research. Then, each of the groups of zero, one and two are placed inside the closed envelopes and the envelopes are numbered on them so as not to disturb them. After the patients are admitted to the study according to the inclusion and exclusion criteria, the envelopes are opened in order to determine which group each patient will be in, Blinding description: In this study, the person performing the assessments did not know which group each patient was in. Finally, the data obtained from the study are provided for analysis to a person who is unaware of the therapy groups .</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parkinson’s Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Combined speech  and music therapy using telerehabilitation.. This group receive speech and music exercises at the same time in each treatment session. Speech exercises includes routine breathing exercises, loudness, pitch and speech Intelligibility, and music exercises includes posture correction, breathing exercises, warm-up exercises, voice exercises and singing exercises.The duration of the intervention is 4 weeks and the exercises are performed three times a week by a speech and language pathologist and a music and song specialist via video call on WhatsApp. Intervention 2: control group 1:  speech therapy. this Group performs common and routine speech exercises, including breathing exercises, loudness, pitch, and intelligibility, which are the authority to use LSVT therapy and voice exercises. The duration of the intervention is 4 weeks and the exercises are performed three times a week by a speech and language pathologist  via video call on WhatsApp. Intervention 3: Control group 2: music therapy. The music exercises used in this study for music therapy group  are designed based on the music therapy protocols of previous studies and It consists of five parts: Part 1: Motor exercises; Section 2: Breathing Exercises; Section 3: vocal  Exercises; Section 4: Singing Exercises; Section 5: Final Conversation and Homework. The duration of the intervention is 4 weeks and the exercises are performed three times a week by a speech and language pathologist  via video call on WhatsApp.</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:
All data or results of the present study will be presentation in an article or 
 some articles that will be published, also will be available through correspondence with the corresponding author.

When:
After completing the present study and publishing the resulting article or articles.

To whom:
All researchers in the field of the present study

Conditions:
With the same goal as the present study and with mention of the present study as the reference. All intellectual property rights of the present study belongs to the   Iran University of Medical Sciences.

Where to obtain:
The corresponding author of the article or articles derived from the study

How to obtain:
Written request from the author responsible fore the the present review after the publication of the article or articles

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reyhaneh Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Speech Therapy, school of Rehabilitation science, Iran University of Medical Sciences, Madadakaran St, ShahNazari Ave, Mother square, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>mohamadi.re88@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab Mohseni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Speech Therapy, school of Rehabilitation science, Iran University of Medical Sciences, Madadakaran St, ShahNazari Ave, Mother square, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>zeynab_mohsny@yshoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with idiopathic Parkinson's disease (IPD)
Patients in terms of disease severity in stages 1-3 based on the Hoehn &amp; Yahr test
Patient or family complaints about individual speech
Ability to use r telerehabilitation and have a smartphone
Adequate vision and hearing
Use of drug therapy
No history of stroke, head injury, brain surgery and laryngeal diseases such as vocal cord nodules, etc.
No other neurological disorders other than idiopathic Parkinson's disease
Do not use treatments other than medication (such as deep brain stimulation surgery (DBS))</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If a patient develops a stroke or other neurological complication during treatment, they are excluded from the treatment plan.
•	Lack of cooperation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Combined speech  and music therapy using telerehabilitation.. This group receive speech and music exercises at the same time in each treatment session. Speech exercises includes routine breathing exercises, loudness, pitch and speech Intelligibility, and music exercises includes posture correction, breathing exercises, warm-up exercises, voice exercises and singing exercises.The duration of the intervention is 4 weeks and the exercises are performed three times a week by a speech and language pathologist and a music and song specialist via video call on WhatsApp.</i_keyword>
      <i_keyword>control group 1:  speech therapy. this Group performs common and routine speech exercises, including breathing exercises, loudness, pitch, and intelligibility, which are the authority to use LSVT therapy and voice exercises. The duration of the intervention is 4 weeks and the exercises are performed three times a week by a speech and language pathologist  via video call on WhatsApp.</i_keyword>
      <i_keyword>Control group 2: music therapy. The music exercises used in this study for music therapy group  are designed based on the music therapy protocols of previous studies and It consists of five parts: Part 1: Motor exercises; Section 2: Breathing Exercises; Section 3: vocal  Exercises; Section 4: Singing Exercises; Section 5: Final Conversation and Homework. The duration of the intervention is 4 weeks and the exercises are performed three times a week by a speech and language pathologist  via video call on WhatsApp.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Voice parameters ( loudness, fundamental frequency , The highest and lowest frequency they can produce, jitter and shimmer). Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: praat software.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Voice Handicap Index. Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: Persian version of Voice Handicap Index.</sec_outcome>
      <sec_outcome>Maximum phonation time. Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: The maximum amount of time a person can sustain phonation of "ah" is timed.</sec_outcome>
      <sec_outcome>Speech Intelligibility. Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: seven scale of  Fodala rankings.</sec_outcome>
      <sec_outcome>Swallowing Disturbance Questionnaire. Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: Persian version of Swallowing Disturbance Questionnaire.</sec_outcome>
      <sec_outcome>Dysphagia handicap index. Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: Persian version of Dysphagia handicap index.</sec_outcome>
      <sec_outcome>Northwest dysphagia patient check sheet. Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: Persian version of northwest dysphagia patient check sheet.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: Persian version of quality of life  test  36 questions.</sec_outcome>
      <sec_outcome>Geriatric Depressive Scale. Timepoint: Before the intervention, after the intervention, one month after the intervention. Method of measurement: Persian version of Geriatric Depressive Scale.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-07</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Department of Speech Therapy, school of Rehabilitation science, Iran University of Medical Sciences, Madadakaran St, ShahNazari Ave, Mother square, Mirdamad Ave, Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
