<?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>IRCT20240306061198N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-17</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>The Effects of roods ontogenic motor patterns on trunk control and balance and motor skill and primitive reflexes among spastic diplegic cerebral palsy</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of roods ontogenic motor patterns on trunk control and balance in spastic diplegic cerebral palsy children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75967</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Spastic diplegic cerebral palsy gross motor function pediatric berg balance scale, Randomization description: non-probability consecutive sampling, The randomization will be done with the help of Chit &amp; Draw method. Chit: A chit is a small piece of paper or token, often with a number or other identifier written on it. In randomization processes involving chits, each chit represents a specific outcome or option. Chits are typically placed into a container, such as a hat or a bowl, and then drawn at random to determine the outcome. This method ensures randomness because each chit has an equal chance of being selected. Draw: Drawing is the action of randomly selecting a chit or card from a container. In this method, a person reaches into the container without looking and selects one item (chit or card) at random. The selected item determines the outcome of the randomization process. Drawing is often used in situations where physical objects like chits, cards, or tokens are involved. Both chit and draw methods are straightforward and widely used for generating random outcomes in various contexts, from simple games to more complex decision-making processes. They provide a fair and unbiased way to select from a set of options without any predetermined, Blinding description: Single blinded study was conducted to minimize the chance of biasness, this study design was used to allocate the members in comparable groups.This descriptions involve concealing details that could bias assessors when evaluating retrieval systems or algorithms. This ensures fair and unbiased evaluation of the systems' performance.</study_design>
      <phase>1</phase>
      <hc_freetext>Spastic Diplegic Cerebral Palsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: FES with Rood ontogenic motor pattern,Roods Ontogenic Patterns These are normal developmental patterns which will used as a basis for therapy. These patterns have beneficial effects when combined with occupational engagement and can be used for inhibiting or facilitating by positioning in these patterns.1. Supine withdrawal (Supine flexion): Total flexion response toward the vertebral level of T10. this position is protective because flexion of the neck and crossing of the arms and legs protect the anterior surface of the body. this pattern is recommended for individuals dominated by extensor tone.2. Rollover (Toward side lying): Rollover is a mobility pattern for extremities and activates the lateral trunk musculature. it is encouraged for individuals who are dominated by tonic reflex patterns in the supine position.3. Pivot prone (prone extension): This position demands full range extension of neck, shoulders, trunk, and lower extremities. it is both a stability and mobility pattern. it plays an important role in preparation for stability of the extensor muscles in the upright position.4. Neck co-contraction (co-innervation): This action is thought to activate both flexors and deep tonic extensors of the neck. this position elicits tonic labyrinthine righting reaction and also promotes stability and extra ocular control.5. On elbows (prone on elbows): Bearing weight on elbows stretches the upper trunk musculature to influence stability of the scapular and gleno-humeral regions. this position is inhibitory to symmetrical tonic neck reflex.6. All fours (quadruped position): The lower trunk and lower extremities are brought into a co contraction pattern. The weight shifting is preparatory to equilibrium responses.7. Static standing: Assuming the bipedal position. this position brings about higher-level neurological integration, such as righting reactions and equilibrium reactions. 8. Walking: Walking includes stance phase, push off, swing, heel strike and stride length. it is a sophisticated process requiring coordinated movement patterns of various parts of body including weight shifting. Intervention 2: Control group:  functional electrical stimulation with conservative physical therapy treatment.</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:
The effect of Roods ontogenic motor pattern on trunk control and balance in spastic diplegic cerebral palsy. Data was assembled with respect to muscle tone measured by Modified Ashworth Scale (Grade 0-2), Gross Motor Function Classification System (GMFCS) Grade (II, III, IV), a Gross Motor Function-88 Questionnaires to assessed trunk control and motor skill &amp; balance assessed by PBBS more than 20 as outcome measure tools.

When:
15 days after publication

To whom:
google scholar,pedro

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 in understanding the available data and its potential applications.

Where to obtain:
The University of Faisalabad
38000
https://tuf.edu.pk/
0092 41 875 0971-5
Fax: +92 41 875 0970

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 ,Canal Road, Faisalabad, Punjab</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 335 7916317</telephone>
        <email>zainboota9698@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Wardah Jabbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisal Town, West ,Canal Road, Faisalabad, Punjab</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>0092413138650848</telephone>
        <email>wardah.jabbar5@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both gender male and female.
Child age with 3-10 years.
Child able to follow verbal command.
Children with GMFS level (II, III, IV)
Children with Modified Ashworth scale (0-2)
Pediatric balance scale more than 20 score</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children who were uncooperative
Children who have visual and intellectual impairments
Use of anti-epileptic &amp; anti-spasticity medications
CP include (Hemiplegic CP, Quadriplegic CP, Ataxic CP, Athetoid CP, Mixed CP, Hypotonic CP)
With any Hearing deficit
Sensory loss
Tumors
Children with severe mental abnormality
Any cardiac anomalies affecting exercise tolerance
Less than 4 months after undergoing orthopedic surgery
Usage of botulism toxins Injections
With any bony Malalignment
Contractures</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Congenital spastic paralysis (cerebral)     Spastic cerebral palsy NOS</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: FES with Rood ontogenic motor pattern,Roods Ontogenic Patterns These are normal developmental patterns which will used as a basis for therapy. These patterns have beneficial effects when combined with occupational engagement and can be used for inhibiting or facilitating by positioning in these patterns.1. Supine withdrawal (Supine flexion): Total flexion response toward the vertebral level of T10. this position is protective because flexion of the neck and crossing of the arms and legs protect the anterior surface of the body. this pattern is recommended for individuals dominated by extensor tone.2. Rollover (Toward side lying): Rollover is a mobility pattern for extremities and activates the lateral trunk musculature. it is encouraged for individuals who are dominated by tonic reflex patterns in the supine position.3. Pivot prone (prone extension): This position demands full range extension of neck, shoulders, trunk, and lower extremities. it is both a stability and mobility pattern. it plays an important role in preparation for stability of the extensor muscles in the upright position.4. Neck co-contraction (co-innervation): This action is thought to activate both flexors and deep tonic extensors of the neck. this position elicits tonic labyrinthine righting reaction and also promotes stability and extra ocular control.5. On elbows (prone on elbows): Bearing weight on elbows stretches the upper trunk musculature to influence stability of the scapular and gleno-humeral regions. this position is inhibitory to symmetrical tonic neck reflex.6. All fours (quadruped position): The lower trunk and lower extremities are brought into a co contraction pattern. The weight shifting is preparatory to equilibrium responses.7. Static standing: Assuming the bipedal position. this position brings about higher-level neurological integration, such as righting reactions and equilibrium reactions. 8. Walking: Walking includes stance phase, push off, swing, heel strike and stride length. it is a sophisticated process requiring coordinated movement patterns of various parts of body including weight shifting</i_keyword>
      <i_keyword>Control group:  functional electrical stimulation with conservative physical therapy treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Trunk control. Timepoint: baseline intervention and 5weeks post intervention. Method of measurement: gross motor function scale.</prim_outcome>
      <prim_outcome>Gross motor function. Timepoint: baseline intervention and 5 weeks post intervention. Method of measurement: Gross motor function scale.</prim_outcome>
      <prim_outcome>Balance. Timepoint: baseline intervention and 5 weeks post intervention. Method of measurement: pediatric berg balance scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Modified Ashworth scale for spasticity. Timepoint: before and after 5 weeks of intervention. Method of measurement: Modified Ashworth 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>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 Committee 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>
