<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/NCT03755648</url>
  </required_header>
  <id_info>
    <org_study_id>12345</org_study_id>
    <nct_id>NCT03755648</nct_id>
  </id_info>
  <brief_title>Effect of Delorme Resistance Exercises Versus Treadmill Training in Cerebral Palsy</brief_title>
  <official_title>Effect of Delorme Resistance Exercises Versus Treadmill Training on Locomotor Abilities in Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ghurki Trust and Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ghurki Trust and Teaching Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cerebral palsy is one of the most important source of disability among children and its&#xD;
      incidence is almost 3.6 in thousand live births.Children with Cerebral Palsy presents with&#xD;
      ambulatory difficulties.The current study highlights the effect of treadmill training as&#xD;
      compared to DeLorme resistance exercises on locomotor activities in cerebral palsy child.The&#xD;
      present study would add to the clinical knowledge of physical therapists by promoting the&#xD;
      implementation of treadmill training and DeLorme resistance exercises for this prevalent&#xD;
      pediatric neurodevelopmental disorder. The study would decrease the burden of disease among&#xD;
      community and enhance the social participation of cerebral palsy children. This in turn would&#xD;
      improve the quality of living of these disabling diseased children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2018</start_date>
  <completion_date type="Actual">October 15, 2018</completion_date>
  <primary_completion_date type="Actual">September 18, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Locomotor ability</measure>
    <time_frame>1 month</time_frame>
    <description>Locomotor ability was assessed using ABILOCO-kids questionnaire. It consisted of 10 locomotion activities of which difficulty was rated by the parents. It has good reliability r=0.97 and reproducibility of 0.96. Parent is asked to fill in questionnaire by estimating their child's ease or difficulty in performing each activity. Activities are presented in 10 different random orders to avoid any systematic effect. During evaluation, 3-level response scale is presented to parent. Parent is asked to rate his perception on response scale as 'Impossible', 'Difficult' or 'Easy'. Activities not attempted by child within last 3 months are not scored and are entered as not applicable. Activities that child doesn't perform because they are too difficult must be scored as 'Impossible'. Child's locomotion ability and its 95% confidence interval are located on locomotion ability scale expressed in logits. Higher the ability of a child the more the measure will be located to the right.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Treadmill training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A: received treadmill training along with traditional physiotherapy.. The motorized treadmill was used keeping treatment parameters as 50 Hertz, 10 Ampere and 220 Volts The treadmill training was provided by giving instructions first and then warm up was given for 5 minutes prior to the training. The children were upright with the feet flat on treadmill platform. The height of handrails was adjustable according to every child thus keeping their gaze forward. The training was ended at cool down period of 5 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional physical therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Traditional therapy includes use of hot packs for 15 minutes and stretching for 20 minutes which will be applied to both groups prior to actual intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delorme Resistance exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B received delorme resistance exercise with traditional physiotherapy. Delorme Resistance Training was also initiated with 5 minute warm up period. It was started with 10 Repetition Maximum and was gradually increased. The treatment session was thirty minutes for each group, six times a week for three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treadmill training</intervention_name>
    <description>The motorized treadmill treatment parameters considered will be 50 Hertz, 10 Ampere and 220 Volts. The speed of treadmill will be controlled with a single finger tip allowing an individual to exercise in safe environment with sufficient space.The treadmill training will be provided by giving instructions first and then warm up will be given for 5 minutes prior to the training. The children will be upright with the feet flat on treadmill platform. The height of handrails will be adjustable according to every child thus keeping their gaze forward. The training will be ended at cool down period of 5 minutes.The treatment session will be thirty minutes for each group, six times a week for three months.</description>
    <arm_group_label>Treadmill training</arm_group_label>
    <other_name>traditional physical therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>traditional physical therapy</intervention_name>
    <description>Traditional therapy includes hot pack for 15 minutes and stretching for 20 minutes</description>
    <arm_group_label>traditional physical therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Delorme resistance exercise</intervention_name>
    <description>Delorme Resistance Training was also initiated with 5 minute warm up period. It was started with 10 Repetition Maximum and was gradually increased. The treatment session was thirty minutes for each group, six times a week for three months.</description>
    <arm_group_label>Delorme Resistance exercise</arm_group_label>
    <other_name>traditional physical therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with Gross Motor Functional Scale Level II and III&#xD;
&#xD;
          -  Ability to understand commands and directions&#xD;
&#xD;
          -  Diplegic type of cerebral palsy&#xD;
&#xD;
          -  Children who had undergone bilateral Tendon of Achilles Lengthening procedure 3 to 6&#xD;
             months post-operatively&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children presenting with other types of Cerebral Palsy&#xD;
&#xD;
          -  Children with audiovisual impairment that can hinder the treatment&#xD;
&#xD;
          -  leg length discrepancy greater than 2 cm,&#xD;
&#xD;
          -  Fixed contractures, joint instability and associated cardiovascular condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hafiz Asim, DPT (USA)</last_name>
    <role>Study Chair</role>
    <affiliation>Lahore Medical and Dental college</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samreen Sadiq</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>October 2018</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ghurki Trust and Teaching Hospital</investigator_affiliation>
    <investigator_full_name>Samreen Sadiq</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Delorme resistance exercises</keyword>
  <keyword>treadmill training</keyword>
  <keyword>locomotor abilities</keyword>
  <keyword>tendon of achilles lengthening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03755648/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03755648/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03755648
org study id: 12345
nct id: NCT03755648
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cerebral palsy is one of the most important source of disability among children and its
      incidence is almost 3.6 in thousand live births.Children with Cerebral Palsy presents with
      ambulatory difficulties.The current study highlights the effect of treadmill training as
      compared to DeLorme resistance exercises on locomotor activities in cerebral palsy child.The
      present study would add to the clinical knowledge of physical therapists by promoting the
      implementation of treadmill training and DeLorme resistance exercises for this prevalent
      pediatric neurodevelopmental disorder. The study would decrease the burden of disease among
      community and enhance the social participation of cerebral palsy children. This in turn would
      improve the quality of living of these disabling diseased children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Locomotor ability
time frame: 1 month
description: Locomotor ability was assessed using ABILOCO-kids questionnaire. It consisted of 10 locomotion activities of which difficulty was rated by the parents. It has good reliability r=0.97 and reproducibility of 0.96. Parent is asked to fill in questionnaire by estimating their child's ease or difficulty in performing each activity. Activities are presented in 10 different random orders to avoid any systematic effect. During evaluation, 3-level response scale is presented to parent. Parent is asked to rate his perception on response scale as 'Impossible', 'Difficult' or 'Easy'. Activities not attempted by child within last 3 months are not scored and are entered as not applicable. Activities that child doesn't perform because they are too difficult must be scored as 'Impossible'. Child's locomotion ability and its 95% confidence interval are located on locomotion ability scale expressed in logits. Higher the ability of a child the more the measure will be located to the right.
arm group label: Treadmill training
arm group type: Experimental
description: Group A: received treadmill training along with traditional physiotherapy.. The motorized treadmill was used keeping treatment parameters as 50 Hertz, 10 Ampere and 220 Volts The treadmill training was provided by giving instructions first and then warm up was given for 5 minutes prior to the training. The children were upright with the feet flat on treadmill platform. The height of handrails was adjustable according to every child thus keeping their gaze forward. The training was ended at cool down period of 5 minutes
arm group label: traditional physical therapy
arm group type: Other
description: Traditional therapy includes use of hot packs for 15 minutes and stretching for 20 minutes which will be applied to both groups prior to actual intervention
arm group label: Delorme Resistance exercise
arm group type: Experimental
description: Group B received delorme resistance exercise with traditional physiotherapy. Delorme Resistance Training was also initiated with 5 minute warm up period. It was started with 10 Repetition Maximum and was gradually increased. The treatment session was thirty minutes for each group, six times a week for three months.
intervention type: Other
intervention name: Treadmill training
description: The motorized treadmill treatment parameters considered will be 50 Hertz, 10 Ampere and 220 Volts. The speed of treadmill will be controlled with a single finger tip allowing an individual to exercise in safe environment with sufficient space.The treadmill training will be provided by giving instructions first and then warm up will be given for 5 minutes prior to the training. The children will be upright with the feet flat on treadmill platform. The height of handrails will be adjustable according to every child thus keeping their gaze forward. The training will be ended at cool down period of 5 minutes.The treatment session will be thirty minutes for each group, six times a week for three months.
arm group label: Treadmill training
other name: traditional physical therapy
intervention type: Other
intervention name: traditional physical therapy
description: Traditional therapy includes hot pack for 15 minutes and stretching for 20 minutes
arm group label: traditional physical therapy
intervention type: Other
intervention name: Delorme resistance exercise
description: Delorme Resistance Training was also initiated with 5 minute warm up period. It was started with 10 Repetition Maximum and was gradually increased. The treatment session was thirty minutes for each group, six times a week for three months.
arm group label: Delorme Resistance exercise
other name: traditional physical therapy
criteria: 
gender: All
minimum age: 6 Years
maximum age: 10 Years
healthy volunteers: No
last name: Hafiz Asim, DPT (USA)
role: Study Chair
affiliation: Lahore Medical and Dental college
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Ghurki Trust and Teaching Hospital
investigator full name: Samreen Sadiq
investigator title: Principal Investigator
mesh term: Cerebral Palsy
provided document: 
provided document: 