<?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>IRCT20250406065222N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-22</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effects of sensory-motor reeducation of the hand on cognitive functions in patients with Parkinson's disease</public_title>
      <acronym></acronym>
      <scientific_title>Effects of sensory-motor reeducation of the hand on cognitive functions in Parkinson's disease patients with mild cognitive disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/87078</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of 30 patients with Parkinson's disease through stratified randomization to two intervention groups (sensorimotor hand rehabilitation) and control (cognitive rehabilitation):
- Type of randomization: stratified randomization;
- Randomization layers: First layer: score 1 to 1.5 on the Hoehn and Yahr scale, second layer: score 2 to 2.5 on the Hoehn and Yahr scale);
- Allocation ratio is 1:1;
- Randomization sequence of assigning samples to groups in each stratum: Given that each patient may enter the study at different times, before starting the allocation of samples, a random sequence is generated to randomly assign individuals to each of the study randomization strata based on the time of entry of individuals (first layer: B, B, A, B, A, B, A, B, A, B, A, B, B, A, A; second layer: A, B, B, A, A, A, A, B, B, B, A, B, B, B, A) - A: Intervention group; B: Control group
- Concealment of the randomization sequence through a sealed envelope containing the name of the assigned group. The names of the randomization strata (first stratum and second stratum) are written on the envelope and the name of the intervention or control group is placed inside the envelope, Blinding description: The person responsible for conducting the assessments is someone other than the people implementing the therapeutic intervention sessions who is not aware of the study groups in terms of the type of therapeutic interventions.
The person responsible for conducting the statistical analyses of the study is also someone other than the group implementing and evaluating the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parkinson.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group - Cognitive rehabilitation: The intervention group's treatment program will include cognitive rehabilitation for 10 one-and-a-half hour sessions, 3 days a week. In the first part of cognitive exercises, common cognitive problems of Parkinson's patients are targeted for treatment through the following exercises: 1. Elimination 2. Number sequences. 3. Problem clarification. 4. Communication. 5. Text comprehension. 6. Recall. 7. Word search. 8. Maze navigation. 9. Classification. 10. Action sequences. 11. Story memory. In the second part of cognitive exercises, cognitive exercises are performed in the form of daily life activities and based on a task-oriented approach in occupational therapy. To implement this approach, daily life activities that the individual has considered important and meaningful in his or her life in the initial assessment session and that have the ability to be implemented in the occupational therapy clinic environment are practiced. Intervention 2: Control group: The treatment program includes hand sensorimotor retraining for 10 one-and-a-half hour sessions, 3 days a week, plus cognitive rehabilitation for 10 one-and-a-half hour sessions, 3 days a week.Sensory-motor rehabilitation of the hand: Sensory-motor exercises of the hand for 45 minutes per session and sensory-motor exercises in the form of daily life activities based on a task-oriented approach in occupational therapy for 45 minutes per session. In the sensory-motor retraining exercises of the hand, sensory retraining exercises and motor retraining exercises are performed in combination with the help of various objects and equipment applied to sensory recovery, muscle strength, and range of motion. In the second part of the sensory-motor retraining exercises of the hand, sensory-motor exercises are performed in the form of daily life activities based on a task-oriented approach in occupational therapy. To implement this approach, daily life activities that the individual has considered important and meaningful in his or her life in the initial assessment session and that have the ability to be performed in the occupational therapy clinic environment are practiced.</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:
6 months after the publication of the study results, the data of the individuals will be made available anonymously only to scientific and academic researchers, if needed.

When:
6 months after the publication of the study results

To whom:
scientific and academic researchers

Conditions:
scientific and academic usages

Where to obtain:
Hamid Reza Rostami
Isfahan University of medical sciences
email: hrr.rostami@gmail.com

How to obtain:
Email: hrr.rostami@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>hamid Reza Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8184667951</zip>
        <telephone>+98 913 432 8034</telephone>
        <email>hrr.rostami@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>hamid reza rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>hezar jarib</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8184667951</zip>
        <telephone>+98 913 432 8034</telephone>
        <email>hrr.rostami@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A patient with Parkinson's disease diagnosed by a neurologist
At least 2 years have passed since the initial diagnosis of Parkinson's disease
Disability level of maximum 2.5 on the Hoehn &amp; Yahr scale
Age 50 to 65 years (age of highest prevalence of Parkinson's disease)
Mild cognitive impairment (score between 20 and 26 on the Montreal Cognitive Assessment Scale)</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of diseases other than Parkinson's</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group - Cognitive rehabilitation: The intervention group's treatment program will include cognitive rehabilitation for 10 one-and-a-half hour sessions, 3 days a week. In the first part of cognitive exercises, common cognitive problems of Parkinson's patients are targeted for treatment through the following exercises: 1. Elimination 2. Number sequences. 3. Problem clarification. 4. Communication. 5. Text comprehension. 6. Recall. 7. Word search. 8. Maze navigation. 9. Classification. 10. Action sequences. 11. Story memory. In the second part of cognitive exercises, cognitive exercises are performed in the form of daily life activities and based on a task-oriented approach in occupational therapy. To implement this approach, daily life activities that the individual has considered important and meaningful in his or her life in the initial assessment session and that have the ability to be implemented in the occupational therapy clinic environment are practiced.</i_keyword>
      <i_keyword>Control group: The treatment program includes hand sensorimotor retraining for 10 one-and-a-half hour sessions, 3 days a week, plus cognitive rehabilitation for 10 one-and-a-half hour sessions, 3 days a week.Sensory-motor rehabilitation of the hand: Sensory-motor exercises of the hand for 45 minutes per session and sensory-motor exercises in the form of daily life activities based on a task-oriented approach in occupational therapy for 45 minutes per session. In the sensory-motor retraining exercises of the hand, sensory retraining exercises and motor retraining exercises are performed in combination with the help of various objects and equipment applied to sensory recovery, muscle strength, and range of motion. In the second part of the sensory-motor retraining exercises of the hand, sensory-motor exercises are performed in the form of daily life activities based on a task-oriented approach in occupational therapy. To implement this approach, daily life activities that the individual has considered important and meaningful in his or her life in the initial assessment session and that have the ability to be performed in the occupational therapy clinic environment are practiced.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognition. Timepoint: Pre-test, Post-test (one month after starting the intervention), follow-up (one month after ending intervention). Method of measurement: The Cambridge Neuropsychological Test Automated Battery.</prim_outcome>
      <prim_outcome>Hand Function. Timepoint: Pre-test, Post-test (one month after starting the intervention), follow-up (one month after ending intervention). Method of measurement: Box&amp;Block test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-16</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
