<?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>IRCT20210615051586N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-09</date_registration>
      <primary_sponsor>The University Of Lahore</primary_sponsor>
      <public_title>Effectiveness of modified constraint induced movement therapy with trunk restraint versus bobath approach on motor function and activities of daily livings in hemiplegic upper extremity after stroke</public_title>
      <acronym>RCT</acronym>
      <scientific_title>Effectiveness of modified constraint induced movement therapy with trunk restraint versus bobath approach on motor function and activities of daily livings in hemiplegic upper extremity after stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56912</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random numbers will be generated from 1-30 using an online random numbers generator in two sets. Set 1 will be assigned modified Constraint-Induced Movement Therapy and set 2 will be physical therapy based on both Concepts. The sealed envelope method will be used to assign patients to both groups, Blinding description: Random numbers will be generated from 1-30 using an online random numbers generator in two sets. Set 1 will be assigned modified Constraint-Induced Movement Therapy and set 2 will be physical therapy based on both Concepts. The sealed envelope method will be used to assign patients to both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sub Acute Hemiplegic Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Group-B: Bobath approach. This approach usually takes one hour per day during 20 sessions. The interventions will group in 5 major items: facilitated movement; mobilization; practicing an activity component; and/or whole task and teaching patients. All interventions, individually program, aims to improving postural control of trunk and shoulder girdle enabling more selective arm movement and increasing strength and function, to recover full motor range patterns, in order to enhance efficiency and maximize function and reducing the severity of impairments where they influence function. Intervention 2: Group-A: Modified Constraint Induced Movement Therapy with trunk restraint. The training was provided at the rehabilitation clinic during a 1-hour therapy session, 5 days per week, for 4 weeks (a total of 20 sessions). The training was based on repetitive and task-specific practice. Participants mCIMT +TR group will be asked to perform tasks with the paretic arm only, with the less-paretic arm restraint in a mitt. During the 4-week period, the participants’ less-paretic hands and wrists will be placed in mitts with self-adhesive straps. Patients in the mCIMT + TR group will be restrained at the trunk by a non-elastic strap during the intervention to limit compensatory movements of the trunk. Arm movement, and pelvic motion were not restricted. The therapist provided consistent verbal feedback to increase the effectiveness of the training. More-affected arm restraint was accomplished by use of a padded mitt that prevented use of the fingers of the less-affected arm.</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 collected deidentified IPD

When:
starting in January 2020

To whom:
people working in academic institutions or people working in businesses can also apply to receive it.

Conditions:
types of analyses, and by what mechanism. Information about who will review requests and criteria for reviewing requests may also be provided.

Where to obtain:
addresses for websites, telephone and fax numbers, and contact persons to whom the applicant should talk.

How to obtain:
Your description should give sufficient insight to the applicant into the amount of time needed to follow through these processes.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tanveer Hussain</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Defense Road Lahore The University Of Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35963424</telephone>
        <email>tanveerhussainpt@gmail.com</email>
        <affiliation>The University Of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tanveer Hussain</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Defense Road Lahore The University Of Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35963424</telephone>
        <email>tanveerhussainpt@gmail.com</email>
        <affiliation>The University Of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient with episode of first stroke between 2 to 12th week of subacute stage.
Both genders, age lies 40-70 years
The first stroke confirmed by C.T, MRI, or clinically by a neuro-physician.
Patient able to perform a functional test of 20° wrist extension and 10° finger extension
The patient had an active range of motion of 45° or more of shoulder flexion, abduction, or scaption and had the capacity to sustain standing balance for 2 min
Patient had Mini Mental State Exam score of greater than or equal to 7</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with shoulder pain (frozen shoulder etc.) or other neurological and orthopedic conditions affecting the reaching movement ability or trunk, hemispatial neglect, or apraxia.
Patient with any comorbidity or disability other than stroke that precludes upper-extremity training
Patient with any uncontrolled health condition for which exercise is contraindicated.
Patient have any psychosocial problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebellar Stroke Syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group-B: Bobath approach. This approach usually takes one hour per day during 20 sessions. The interventions will group in 5 major items: facilitated movement; mobilization; practicing an activity component; and/or whole task and teaching patients. All interventions, individually program, aims to improving postural control of trunk and shoulder girdle enabling more selective arm movement and increasing strength and function, to recover full motor range patterns, in order to enhance efficiency and maximize function and reducing the severity of impairments where they influence function.</i_keyword>
      <i_keyword>Group-A: Modified Constraint Induced Movement Therapy with trunk restraint. The training was provided at the rehabilitation clinic during a 1-hour therapy session, 5 days per week, for 4 weeks (a total of 20 sessions). The training was based on repetitive and task-specific practice. Participants mCIMT +TR group will be asked to perform tasks with the paretic arm only, with the less-paretic arm restraint in a mitt. During the 4-week period, the participants’ less-paretic hands and wrists will be placed in mitts with self-adhesive straps. Patients in the mCIMT + TR group will be restrained at the trunk by a non-elastic strap during the intervention to limit compensatory movements of the trunk. Arm movement, and pelvic motion were not restricted. The therapist provided consistent verbal feedback to increase the effectiveness of the training. More-affected arm restraint was accomplished by use of a padded mitt that prevented use of the fingers of the less-affected arm.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motor Function. Timepoint: At Baseline,  At The End Of 4th Week, And At The End Of 8th Week. Method of measurement: Motor Assessment Scale.</prim_outcome>
      <prim_outcome>Activity Of Daily Livings. Timepoint: At Baseline, At The End Of 4th Week, And At The End Of 8th Week. Method of measurement: Barthel Index Scale.</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>The University Of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-26</approval_date>
        <contact_name>Institutional Review Board, Faculty of Allied Health Sciences, The University of Lahore</contact_name>
        <contact_address>Defense Road Lahore The University Of Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
