<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/NCT04502615</url>
  </required_header>
  <id_info>
    <org_study_id>TeessideUni</org_study_id>
    <nct_id>NCT04502615</nct_id>
  </id_info>
  <brief_title>Effect of Sand on Knee Load and Muscle Activity During a Single Leg Landing Task</brief_title>
  <official_title>Effect of Sand on Knee Load and sEMG Activity During a Single Leg Landing Task: Implications for ACL Prevention and Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teesside University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teesside 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 evaluates the effect of different surfaces on the load experienced by the knee&#xD;
      when landing from a single leg hop. A sand, pliable grass and firm (hard floor) surface will&#xD;
      be compared when hopping from a 30 cm height. Each subject will complete 5 hops on each&#xD;
      surface in a random order. The muscle activity in selected muscles of the lower limb will&#xD;
      also be investigated to see how this differs in the landing leg, when landing on the&#xD;
      different surfaces.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is twofold: 1) To investigate the effect of sand on landing kinematics&#xD;
      and kinetics at the knee joint when performing a single leg jump landing task (dominant leg),&#xD;
      comparing sand with a firm surface and pliable grass control. 2) To investigate the sEMG&#xD;
      activity of the hamstring, quadriceps and gastrocnemius muscles of the dominant leg during&#xD;
      the jump landing task on these different surfaces (from take off through to terminal knee&#xD;
      flexion at the end of the landing phase).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2020</start_date>
  <completion_date type="Actual">December 10, 2021</completion_date>
  <primary_completion_date type="Actual">December 10, 2021</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomised, repeated measures crossover design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>knee abduction moment (N.m)</measure>
    <time_frame>1 testing session (1 day)</time_frame>
    <description>a combination of ground force and amount of knee valgus on landing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>knee valgus</measure>
    <time_frame>1 testing session (1 day)</time_frame>
    <description>angle at the knee on landing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>surface electromyography (sEMG) activity pre and post landing</measure>
    <time_frame>1 testing session (1 day)</time_frame>
    <description>muscle activity of quadriceps (vastus medialis, vastus lateralis), hamstrings (lateral and medial), gastroc (lateral head)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anterior tibial translation</measure>
    <time_frame>1 testing session(1 day)</time_frame>
    <description>The amount of forward translation of the tibia when landing on the surface</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Single Leg Hop Sand Surface</condition>
  <condition>Single Leg Hop Grass Surface</condition>
  <condition>Single Leg Hop Firm Surface</condition>
  <arm_group>
    <arm_group_label>Sand</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants perform 5 single leg hops onto a Sand surface from a 30cm height</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Artificial grass</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants perform 5 single leg hops onto a grass surface from a 30cm height</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Firm Ground</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants perform 5 single leg hops onto a firm ground surface from a 30cm height</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sand</intervention_name>
    <description>sand surface</description>
    <arm_group_label>Sand</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>artificial grass</intervention_name>
    <description>grass surface</description>
    <arm_group_label>Artificial grass</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>firm ground</intervention_name>
    <description>firm surface</description>
    <arm_group_label>Firm Ground</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Participate in a minimum of 3 hours sporting activity per week.&#xD;
&#xD;
          -  Provided Informed Consent&#xD;
&#xD;
          -  Must be over 16 years of age (16-45 years)&#xD;
&#xD;
          -  No exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not willing to provide informed consent&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  History of ACL injury or other knee pathology&#xD;
&#xD;
          -  Significant lower limb pathology&#xD;
&#xD;
          -  Previous lower limb fracture or surgery&#xD;
&#xD;
          -  Lower Limb injury in last 3 months.&#xD;
&#xD;
          -  Male&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>most be female to be eligible for the study</gender_description>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Richardson, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Teesside University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Teesside University</name>
      <address>
        <city>Middlesbrough</city>
        <zip>TS1 3BA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Teesside University</investigator_affiliation>
    <investigator_full_name>Mark Richardson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Sand</keyword>
  <keyword>knee valgus</keyword>
  <keyword>knee abduction moment</keyword>
  <keyword>electromyography</keyword>
  <!-- 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/NCT04502615
org study id: TeessideUni
nct id: NCT04502615
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of different surfaces on the load experienced by the knee
      when landing from a single leg hop. A sand, pliable grass and firm (hard floor) surface will
      be compared when hopping from a 30 cm height. Each subject will complete 5 hops on each
      surface in a random order. The muscle activity in selected muscles of the lower limb will
      also be investigated to see how this differs in the landing leg, when landing on the
      different surfaces.
The aim of this study is twofold: 1) To investigate the effect of sand on landing kinematics
      and kinetics at the knee joint when performing a single leg jump landing task (dominant leg),
      comparing sand with a firm surface and pliable grass control. 2) To investigate the sEMG
      activity of the hamstring, quadriceps and gastrocnemius muscles of the dominant leg during
      the jump landing task on these different surfaces (from take off through to terminal knee
      flexion at the end of the landing phase).
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomised, repeated measures crossover design.
primary purpose: Treatment
masking: None (Open Label)
measure: knee abduction moment (N.m)
time frame: 1 testing session (1 day)
description: a combination of ground force and amount of knee valgus on landing
measure: knee valgus
time frame: 1 testing session (1 day)
description: angle at the knee on landing
measure: surface electromyography (sEMG) activity pre and post landing
time frame: 1 testing session (1 day)
description: muscle activity of quadriceps (vastus medialis, vastus lateralis), hamstrings (lateral and medial), gastroc (lateral head)
measure: Anterior tibial translation
time frame: 1 testing session(1 day)
description: The amount of forward translation of the tibia when landing on the surface
arm group label: Sand
arm group type: Experimental
description: Participants perform 5 single leg hops onto a Sand surface from a 30cm height
arm group label: Artificial grass
arm group type: Active Comparator
description: Participants perform 5 single leg hops onto a grass surface from a 30cm height
arm group label: Firm Ground
arm group type: Active Comparator
description: Participants perform 5 single leg hops onto a firm ground surface from a 30cm height
intervention type: Other
intervention name: Sand
description: sand surface
arm group label: Sand
intervention type: Other
intervention name: artificial grass
description: grass surface
arm group label: Artificial grass
intervention type: Other
intervention name: firm ground
description: firm surface
arm group label: Firm Ground
criteria: 
gender: Female
gender based: Yes
gender description: most be female to be eligible for the study
minimum age: 16 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Richardson, MSc
role: Principal Investigator
affiliation: Teesside University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Teesside University
investigator full name: Mark Richardson
investigator title: Principal Investigator