xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06015555</url>
    </required_header>
    <id_info>
      <org_study_id>RiphahIU- Farhan</org_study_id>
      <nct_id>NCT06015555</nct_id>
    </id_info>
    <brief_title>TAMO Therapy Versus Postural Control Exercise in Children With Congenital Muscular Torticollis</brief_title>
    <official_title>Effect Of Postural Control Exercise Versus¬¬ Tscharnuter Akademie For Motor Organization (TAMO) Therapy On Range Of Motion And Motor Function In Children With Congenital Muscular Torticollis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>khadija liaquat</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A randomized control trial was conducted through convenient sampling. 18 subjects were&#xD;
        randomly allocated into two groups, group A received postural control exercises in addition&#xD;
        to conventional therapy, while Group B received TAMO therapy along with conventional therapy.&#xD;
        analysis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Torticollis is common in children and can be congenital or acquired. Acquired cases can&#xD;
        result from neck muscles or bone injuries. Though distressing for parents, it usually&#xD;
        improves over time. Treatment includes postural control exercise and TAMO therapy, along with&#xD;
        conventional treatment. To compare the effects of TAMO therapy versus postural control&#xD;
        exercises on children with congenital muscular torticollis on cervical range of motion. A&#xD;
        randomized control trial was conducted through convenient sampling. Eighteen subjects were&#xD;
        randomly allocated into two groups; Group A received postural control exercises in addition&#xD;
        to conventional therapy, while group B received TAMO therapy along with conventional therapy.&#xD;
        The duration of the treatment was eight weeks. Goniometer, still photography, muscle&#xD;
        function. Eighteen participants (n=18) were included in the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 23, 2023</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 25, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Goniometer</measure>
      <time_frame>Readings were taken at baseline and four months of intervention</time_frame>
      <description>It measured cervical range of motion.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Muscle function Scale:</measure>
      <time_frame>Readings were taken at baseline and four months of intervention</time_frame>
      <description>MFS is a tool used to check the function of the lateral flexors, a scale of 0 to 5, with higher scores indicating better function of muscles.Readings were taken at baseline and after four months of intervention of the neck in children,</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">18</enrollment>
    <condition>Torticollis Congenital</condition>
    <arm_group>
      <arm_group_label>The TAMO therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>For four months, TAMO therapy will last 30 minutes every day, twice a week. The therapist first applies light loading for a short period of time to his left hemiocciput directed toward the supporting surface.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Postural Control exercises</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>For four months, posture control exercises will be taught twice a week for 30 minutes each time. Under the age of 3 months, infants were required to shift their chin as far to the affected side and upward in the supine or dominant prone posture before they could regulate their neck. Instead of passively adjusting the newborns' heads, we waited for them to actively turn toward their midline.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>TAMO</intervention_name>
      <description>TAMO therapy</description>
      <arm_group_label>The TAMO therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Postural Control exercises</intervention_name>
      <description>Postural Control exercises</description>
      <arm_group_label>Postural Control exercises</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Greater than 3 months&#xD;
  &#xD;
            -  Both genders&#xD;
  &#xD;
            -  Abnormal neck posture&#xD;
  &#xD;
            -  Torticollis of both sides&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  SCM mass present&#xD;
  &#xD;
            -  Deficit in cervical PROM greater than 15 degree&#xD;
  &#xD;
            -  Craniosynostosis (it is a birth defect in which the bones in a baby skull join&#xD;
               together too early)&#xD;
  &#xD;
            -  Infectious&#xD;
  &#xD;
            -  Metabolic&#xD;
  &#xD;
            -  Scoliosis of spine&#xD;
  &#xD;
            -  Developmental plagiocephaly&#xD;
  &#xD;
            -  SCM tumor&#xD;
  &#xD;
            -  Visual disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Months</minimum_age>
      <maximum_age>6 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Riphah Rehabilitation Center, Riphah International University</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>54000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Riphah International University</investigator_affiliation>
      <investigator_full_name>khadija liaquat</investigator_full_name>
      <investigator_title>Senior lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Torticollis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06015555
  org study id: RiphahIU- Farhan
  nct id: NCT06015555
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A randomized control trial was conducted through convenient sampling. 18 subjects were
        randomly allocated into two groups, group A received postural control exercises in addition
        to conventional therapy, while Group B received TAMO therapy along with conventional therapy.
        analysis.
  Torticollis is common in children and can be congenital or acquired. Acquired cases can
        result from neck muscles or bone injuries. Though distressing for parents, it usually
        improves over time. Treatment includes postural control exercise and TAMO therapy, along with
        conventional treatment. To compare the effects of TAMO therapy versus postural control
        exercises on children with congenital muscular torticollis on cervical range of motion. A
        randomized control trial was conducted through convenient sampling. Eighteen subjects were
        randomly allocated into two groups; Group A received postural control exercises in addition
        to conventional therapy, while group B received TAMO therapy along with conventional therapy.
        The duration of the treatment was eight weeks. Goniometer, still photography, muscle
        function. Eighteen participants (n=18) were included in the study.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Goniometer
  time frame: Readings were taken at baseline and four months of intervention
  description: It measured cervical range of motion.
  measure: Muscle function Scale:
  time frame: Readings were taken at baseline and four months of intervention
  description: MFS is a tool used to check the function of the lateral flexors, a scale of 0 to 5, with higher scores indicating better function of muscles.Readings were taken at baseline and after four months of intervention of the neck in children,
  arm group label: The TAMO therapy
  arm group type: Experimental
  description: For four months, TAMO therapy will last 30 minutes every day, twice a week. The therapist first applies light loading for a short period of time to his left hemiocciput directed toward the supporting surface.
  arm group label: Postural Control exercises
  arm group type: Experimental
  description: For four months, posture control exercises will be taught twice a week for 30 minutes each time. Under the age of 3 months, infants were required to shift their chin as far to the affected side and upward in the supine or dominant prone posture before they could regulate their neck. Instead of passively adjusting the newborns' heads, we waited for them to actively turn toward their midline.
  intervention type: Behavioral
  intervention name: TAMO
  description: TAMO therapy
  arm group label: The TAMO therapy
  intervention type: Behavioral
  intervention name: Postural Control exercises
  description: Postural Control exercises
  arm group label: Postural Control exercises
  criteria: 
  gender: All
  minimum age: 3 Months
  maximum age: 6 Months
  healthy volunteers: No
  facility: 
  country: Pakistan
  responsible party type: Sponsor-Investigator
  investigator affiliation: Riphah International University
  investigator full name: khadija liaquat
  investigator title: Senior lecturer
  mesh term: Torticollis
  sharing ipd: Undecided