<?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>IRCT20240314061290N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-27</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>neurological music therapy on older adults with mild cognitive impairment</public_title>
      <acronym></acronym>
      <scientific_title>Effect of neurological music therapy on older adults with mild cognitive impairment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76105</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple random sampling technique with lottery method, Blinding description: he individuals responsible for assessing or measuring the study outcomes are kept unaware of the participants' treatment group assignments or intervention status.</study_design>
      <phase>2</phase>
      <hc_freetext>Mild cognitive impairment.</hc_freetext>
      <i_freetext>Intervention 1: Active Control group: In this control group, an instructor will guide the participants through the same exercises that will perform in the MMT group by giving counts only, without accompanying background music or use of the Naruko clapper. Both interventions will conduct once a week for 12 weeks. Intervention 2: Intervention group: In the MMT intervention group, each MMT session started with a 20 min warm-up period including about 5 min of light exercise completed in synchronization with background music. The next 15 min involved exercises with background music that aimed to strengthen leg muscles for fall prevention.This was followed by 30 min of MMT during which the participants used the Naruko clapper to accompany the music will play for 4 min, followed by ‘March of 365 steps’ (3 min), ‘Hakodatenohito’ (3 min), ‘Palm in the sun’(3 min), ‘Kiyoshi’s Zundoko’ (4 min), etc. Each session, will select 2 songs music and will repeat them for 30 min. These songs will repeat three times per one song, two songs per a session. It will include an explanation of each move, times to wipe sweat and to water supply between song and song for 2 min. The session will end with relaxation exercises, as well as deep breathing and massage to accompanying background music.</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:
Effect of neurological music therapy on older adults with mild cognitive impairment

When:
15 days after publication

To whom:
Google scholar

Conditions:
Access to the data will be facilitated through a specified mechanism, such as a secure online portal or data sharing platform. Requests for access will be reviewed by a designated committee or entity responsible for ensuring that they meet the established criteria and comply with relevant regulations and guidelines. Additional supporting information and documents may be provided to assist requesters

Where to obtain:
The University of Faisalabad 38000 https://tuf.edu.pk/ 00924187509715

How to obtain:
To receive the documents or data files, the process typically involves the following steps: 1. Request Initiation: The applicant submits a formal request specifying the documents or data files they need. 2. Verification and Authorization: The organization verifies the request and ensures that the applicant is authorized to access the requested documents or data files. This may involve confirming the identity of the requester and checking their permissions. 3. Processing Time: The processing time varies depending on the complexity of the request, the volume of documents or data files, and any legal or regulatory requirements. It could range from a few hours to several weeks. 4. Document Retrieval or Data Extraction: Once the request is approved, the organization retrieves the documents from their archives or extracts the requested data from their databases. 5. Quality Assurance: Before releasing the documents or data files to the applicant, the organization may conduct quality checks to ensure accuracy and completeness. 6. Delivery: The documents or data files are delivered to the applicant through a secure channel, such as encrypted email, secure file transfer protocols, or a secure online portal. 7. Confirmation of Receipt: The applicant acknowledges receipt of the documents or data files, confirming that they have received the information they requested.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Zainab Boota;PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisal Town, West Canall Road, Faisalabad, Punjab</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>0092 41 3357916317</telephone>
        <email>zainboota9698@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Warda Jabbar;PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisal Town, West Canal Road, Faisalabad, Punjab</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>0092 41 313 8650848</telephone>
        <email>Wardah.jabbar5@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both Male and female
Presence of MCI (Montreal Cognitive Assessment score &lt; 26)
Being able to walk safely
A low level of physical activity assessed by means of a physical activity questionnaire.
Age 60-80 years</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Older adults with visual impairment and those with hearing problems
History of cardiovascular disease
Presence of  neurological disorder ( Parkinson's disease, multiple sclerosis )
Patients having Serious motor deficits
Patient having difficulty in moving and communicating
Left-handed or ambidextrous
Patient having diagnosis of severe cognitive impairment such as dementia.
Presence of depression</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>A disorder characterized by impairment of memory, learning difficulties, and reduced ability to concentrate on a task for more than brief periods. There is often a marked feeling of mental fatigue when mental tasks are attempted, and new learning is found</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Active Control group: In this control group, an instructor will guide the participants through the same exercises that will perform in the MMT group by giving counts only, without accompanying background music or use of the Naruko clapper. Both interventions will conduct once a week for 12 weeks.</i_keyword>
      <i_keyword>Intervention group: In the MMT intervention group, each MMT session started with a 20 min warm-up period including about 5 min of light exercise completed in synchronization with background music. The next 15 min involved exercises with background music that aimed to strengthen leg muscles for fall prevention.This was followed by 30 min of MMT during which the participants used the Naruko clapper to accompany the music will play for 4 min, followed by ‘March of 365 steps’ (3 min), ‘Hakodatenohito’ (3 min), ‘Palm in the sun’(3 min), ‘Kiyoshi’s Zundoko’ (4 min), etc. Each session, will select 2 songs music and will repeat them for 30 min. These songs will repeat three times per one song, two songs per a session. It will include an explanation of each move, times to wipe sweat and to water supply between song and song for 2 min. The session will end with relaxation exercises, as well as deep breathing and massage to accompanying background music.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>•	Cognitive function. Timepoint: Before and after 6 week of intervention. Method of measurement: Mini-mental state examination (MMSE).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>•	Quality of life. Timepoint: Before and after 6 week of intervention. Method of measurement: SF 36 for Quality of life.</sec_outcome>
      <sec_outcome>•	Physical Function. Timepoint: Before and after 6 week of intervention. Method of measurement: International Physical Activity Questionnaire (IPAQ).</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>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-05</approval_date>
        <contact_name>Research and Ethics/technical committe for The University of Faisalabad</contact_name>
        <contact_address>Faisal Town, West Canal Road, Faisalabad Punjab Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
