<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/NCT03788135</url>
  </required_header>
  <id_info>
    <org_study_id>RRC-2018-011</org_study_id>
    <nct_id>NCT03788135</nct_id>
  </id_info>
  <brief_title>Localized Muscle Cooling on Balance in Healthy Individuals</brief_title>
  <official_title>Effect of Localized Muscle Cooling on Balance in Healthy Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Saud University</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aims to investigate the effects of localized muscle cooling on static and dynamic&#xD;
      stability in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy young adult aged 18-30 years will be recruited from the College of Applied Medical&#xD;
      Sciences (CAMS), King Saud University, Riyadh. Subjects will be excluded if they had a&#xD;
      history of a hip or knee injury, sensory deficits in the lower extremity, a history of&#xD;
      lower-extremity surgery, or a history of a quadriceps or hamstring muscle injury. The&#xD;
      protocol was submitted to and approved by the Ethics Sub-Committee of Rehabilitation Research&#xD;
      chair (RRC-2018-011). Participants will be requested to sign a written informed consent form&#xD;
      approved by the institution ethics committee. A total of 50 participants were randomly&#xD;
      assigned to the quadriceps cooling (QC: n = 10), hamstrings cooling (HC: n = 10), calf&#xD;
      cooling (CC: n = 10), back muscle cooling (BC: n = 10) or control (no cooling: n = 10) group&#xD;
      by a lottery method.A baseline assessment of mean center of gravity (COG), sway velocity&#xD;
      (degrees/sec) for the unilateral Stance (US) will be performed. After the baseline&#xD;
      assessment, a cold pack (gel pack, temperature -6 degrees to -12 degrees Celsius) will be&#xD;
      placed on the target muscle for 20 minutes. One thin dry towel will be kept between the cold&#xD;
      pack and the skin to prevent skin damage. Before and after the application of ice application&#xD;
      the skin sensibility will be assessed by testing the participant's to a pinprick.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2019</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">April 25, 2019</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mean center of gravity (COG) sway velocity (degrees/sec) for the unilateral Stance (US)</measure>
    <time_frame>up to 3 weeks</time_frame>
    <description>The participants will be asked to stood in the marked position on the force plate, with their hands positioned on the iliac crests. The participants will be requested to lift the right foot to a standard height of 10 cm. This 10-second test will be performed three times in two test conditions, including eyes open (EO) and eyes closed (EC). The mean COG sway velocity (degrees/sec) from three trials of the US will be used in the analysis. The participants will be requested to perform the same test for the left leg. The US will be used to determine each participant's ability to maintain postural stability during unilateral standing in the EO and EC conditions.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Quadriceps cooling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive a cold pack on anterior thigh muscles for 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hamstring cooling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive a cold pack on posterior thigh muscles for 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calf cooling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive a cold pack on posterior leg muscles for 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Back cooling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive a cold pack on posterior low back muscles for 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants in the control group will be rested for 20 minutes without any intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cooling</intervention_name>
    <description>the participants in the experimental group will receive a cold pack (gel pack, temperature -6 degrees to -12 degrees Celsius) will be placed on the target muscles for 20 minutes.</description>
    <arm_group_label>Back cooling</arm_group_label>
    <arm_group_label>Calf cooling</arm_group_label>
    <arm_group_label>Hamstring cooling</arm_group_label>
    <arm_group_label>Quadriceps cooling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy young adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of a hip or knee injury, sensory deficits in the lower extremity and lower&#xD;
             back, a history of lower-extremity surgery, spinal surgery, or a history of a&#xD;
             quadriceps or hamstring muscle injury.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AHMAD H ALGHADIR, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>King Saud University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RRC, KSU</name>
      <address>
        <city>Riyadh</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>Shahnawaz Anwer</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be kept secure with the principal investigator (MR. SHAHNAWAZ ANWER) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues</ipd_description>
  </patient_data>
  <!-- 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/NCT03788135
org study id: RRC-2018-011
nct id: NCT03788135
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the effects of localized muscle cooling on static and dynamic
      stability in healthy adults.
Healthy young adult aged 18-30 years will be recruited from the College of Applied Medical
      Sciences (CAMS), King Saud University, Riyadh. Subjects will be excluded if they had a
      history of a hip or knee injury, sensory deficits in the lower extremity, a history of
      lower-extremity surgery, or a history of a quadriceps or hamstring muscle injury. The
      protocol was submitted to and approved by the Ethics Sub-Committee of Rehabilitation Research
      chair (RRC-2018-011). Participants will be requested to sign a written informed consent form
      approved by the institution ethics committee. A total of 50 participants were randomly
      assigned to the quadriceps cooling (QC: n = 10), hamstrings cooling (HC: n = 10), calf
      cooling (CC: n = 10), back muscle cooling (BC: n = 10) or control (no cooling: n = 10) group
      by a lottery method.A baseline assessment of mean center of gravity (COG), sway velocity
      (degrees/sec) for the unilateral Stance (US) will be performed. After the baseline
      assessment, a cold pack (gel pack, temperature -6 degrees to -12 degrees Celsius) will be
      placed on the target muscle for 20 minutes. One thin dry towel will be kept between the cold
      pack and the skin to prevent skin damage. Before and after the application of ice application
      the skin sensibility will be assessed by testing the participant's to a pinprick.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: mean center of gravity (COG) sway velocity (degrees/sec) for the unilateral Stance (US)
time frame: up to 3 weeks
description: The participants will be asked to stood in the marked position on the force plate, with their hands positioned on the iliac crests. The participants will be requested to lift the right foot to a standard height of 10 cm. This 10-second test will be performed three times in two test conditions, including eyes open (EO) and eyes closed (EC). The mean COG sway velocity (degrees/sec) from three trials of the US will be used in the analysis. The participants will be requested to perform the same test for the left leg. The US will be used to determine each participant's ability to maintain postural stability during unilateral standing in the EO and EC conditions.
arm group label: Quadriceps cooling
arm group type: Experimental
description: Participants in this group will receive a cold pack on anterior thigh muscles for 20 minutes.
arm group label: Hamstring cooling
arm group type: Experimental
description: Participants in this group will receive a cold pack on posterior thigh muscles for 20 minutes.
arm group label: Calf cooling
arm group type: Experimental
description: Participants in this group will receive a cold pack on posterior leg muscles for 20 minutes.
arm group label: Back cooling
arm group type: Experimental
description: Participants in this group will receive a cold pack on posterior low back muscles for 20 minutes.
arm group label: Control
arm group type: No Intervention
description: The participants in the control group will be rested for 20 minutes without any intervention.
intervention type: Behavioral
intervention name: cooling
description: the participants in the experimental group will receive a cold pack (gel pack, temperature -6 degrees to -12 degrees Celsius) will be placed on the target muscles for 20 minutes.
arm group label: Back cooling
arm group label: Calf cooling
arm group label: Hamstring cooling
arm group label: Quadriceps cooling
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: AHMAD H ALGHADIR, PHD
role: Study Chair
affiliation: King Saud University
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: Shahnawaz Anwer
investigator title: Principal Investigator
sharing ipd: No
ipd description: Data will be kept secure with the principal investigator (MR. SHAHNAWAZ ANWER) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues