<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/NCT04470570</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000737</org_study_id>
    <nct_id>NCT04470570</nct_id>
  </id_info>
  <brief_title>The Effect of Cross-Education on Shoulder Arthroscopy</brief_title>
  <official_title>The Effects of Cross-Education and Blood Flow Restriction Study on Patients Undergoing Shoulder Arthroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</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>
      The purpose of this study is to examine the effectiveness of a strength training protocol on&#xD;
      the uninjured upper extremity either alone or with the addition of blood flow restriction&#xD;
      (BFR) training on subjects who have undergone shoulder arthroscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine the effectiveness of a strength training protocol on&#xD;
      the uninjured limb either alone or with the addition of blood flow restriction (BFR) training&#xD;
      on the status of the injured limb post shoulder arthroscopy. Patients will be randomized into&#xD;
      one of three standardized physical therapy (PT) groups after shoulder arthroscopy: Control&#xD;
      group (CON), Strength Training on the uninvolved shoulder (STR), strength training with the&#xD;
      BFR on the uninvolved shoulder (BFR). All three patient groups will follow a standardized PT&#xD;
      rehab protocol that is usual standard of care on the involved shoulder. The STR and BFR group&#xD;
      will follow a typical standard of care rehab protocol to the uninvolved side to investigate&#xD;
      the potential effects of cross-education. Isometric strength will be assessed utilizing&#xD;
      handheld dynamometry (HHD) at Kerlan-Jobe during their regularly scheduled pre-operative and&#xD;
      follow-up visits. Patients age 18 and older undergoing shoulder arthroscopy for rotator cuff&#xD;
      repair and/or biceps tenodesis. The study includes 3 visits which are standard of care&#xD;
      pre-operative and post-operative visits. The duration of the study will be 14 weeks. 2 weeks&#xD;
      to allow for a pre-op baseline strength assessment and 12 weeks post-op for the final&#xD;
      assessment during the patients routine follow-up visit. Physical Therapy will be standardized&#xD;
      for all three groups in terms of frequency and rehabilitation protocol. The only exercises&#xD;
      that will be added will be to the intervention groups on the uninvolved side. Patients will&#xD;
      present to physical therapy 2-3 times/week during the duration of the study regardless of&#xD;
      their group allocation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in strength of the shoulder at 6 weeks and 12 weeks</measure>
    <time_frame>pre-operative visit, 6 week post-operative visit, 12-week post-operative visit</time_frame>
    <description>Strength of the shoulder will be assessed via hand-held dynamometer</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Rotator Cuff Tears</condition>
  <condition>Rotator Cuff Injuries</condition>
  <condition>Rotator Cuff Repair</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will undergo a standardized rehabilitation protocol of the involved shoulder only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cross-Education Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cross-Education + Blood-Flow Restriction Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side with blood-flow restriction simultaneously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cross-Education</intervention_name>
    <description>1) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.</description>
    <arm_group_label>Cross-Education + Blood-Flow Restriction Group</arm_group_label>
    <arm_group_label>Cross-Education Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood-Flow Restriction Training</intervention_name>
    <description>1) Blood Flow Restriction: A type of resistance training using a blood-pressure like cuff that partially occludes venous blood flow to induce various neurohormonal effects and allows strength gains to be achieved at very low loads of resistance.</description>
    <arm_group_label>Cross-Education + Blood-Flow Restriction Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  Diagnosed with rotator cuff injury&#xD;
&#xD;
          -  Scheduled for rotator cuff surgery via shoulder arthroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years old&#xD;
&#xD;
          -  History of previous contra-lateral surgery or injury&#xD;
&#xD;
          -  Previous ipsi-lateral upper extremity surgery&#xD;
&#xD;
          -  History of shoulder osteoarthritis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael B Banffy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Kerlan-Jobe Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Kerlan-Jobe Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>March 30, 2021</last_update_submitted>
  <last_update_submitted_qc>March 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Michael Banffy, MD</investigator_full_name>
    <investigator_title>Director, Orthopedic Sports Medicine Fellowship</investigator_title>
  </responsible_party>
  <keyword>biceps tenodesis</keyword>
  <keyword>Cross-Education</keyword>
  <keyword>Blood-Flow Restriction Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available for 6 months after the study has been published.</ipd_time_frame>
  </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/NCT04470570
org study id: STUDY00000737
nct id: NCT04470570
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effectiveness of a strength training protocol on
      the uninjured upper extremity either alone or with the addition of blood flow restriction
      (BFR) training on subjects who have undergone shoulder arthroscopy.
The purpose of this study is to examine the effectiveness of a strength training protocol on
      the uninjured limb either alone or with the addition of blood flow restriction (BFR) training
      on the status of the injured limb post shoulder arthroscopy. Patients will be randomized into
      one of three standardized physical therapy (PT) groups after shoulder arthroscopy: Control
      group (CON), Strength Training on the uninvolved shoulder (STR), strength training with the
      BFR on the uninvolved shoulder (BFR). All three patient groups will follow a standardized PT
      rehab protocol that is usual standard of care on the involved shoulder. The STR and BFR group
      will follow a typical standard of care rehab protocol to the uninvolved side to investigate
      the potential effects of cross-education. Isometric strength will be assessed utilizing
      handheld dynamometry (HHD) at Kerlan-Jobe during their regularly scheduled pre-operative and
      follow-up visits. Patients age 18 and older undergoing shoulder arthroscopy for rotator cuff
      repair and/or biceps tenodesis. The study includes 3 visits which are standard of care
      pre-operative and post-operative visits. The duration of the study will be 14 weeks. 2 weeks
      to allow for a pre-op baseline strength assessment and 12 weeks post-op for the final
      assessment during the patients routine follow-up visit. Physical Therapy will be standardized
      for all three groups in terms of frequency and rehabilitation protocol. The only exercises
      that will be added will be to the intervention groups on the uninvolved side. Patients will
      present to physical therapy 2-3 times/week during the duration of the study regardless of
      their group allocation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change in strength of the shoulder at 6 weeks and 12 weeks
time frame: pre-operative visit, 6 week post-operative visit, 12-week post-operative visit
description: Strength of the shoulder will be assessed via hand-held dynamometer
arm group label: Control Group
arm group type: No Intervention
description: This group will undergo a standardized rehabilitation protocol of the involved shoulder only.
arm group label: Cross-Education Group
arm group type: Experimental
description: This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side.
arm group label: Cross-Education + Blood-Flow Restriction Group
arm group type: Experimental
description: This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side with blood-flow restriction simultaneously.
intervention type: Other
intervention name: Cross-Education
description: 1) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.
arm group label: Cross-Education + Blood-Flow Restriction Group
arm group label: Cross-Education Group
intervention type: Other
intervention name: Blood-Flow Restriction Training
description: 1) Blood Flow Restriction: A type of resistance training using a blood-pressure like cuff that partially occludes venous blood flow to induce various neurohormonal effects and allows strength gains to be achieved at very low loads of resistance.
arm group label: Cross-Education + Blood-Flow Restriction Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael B Banffy, MD
role: Principal Investigator
affiliation: Cedars-Sinai Kerlan-Jobe Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Michael Banffy, MD
investigator title: Director, Orthopedic Sports Medicine Fellowship
mesh term: Rotator Cuff Injuries
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available for 6 months after the study has been published.