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/NCT06009978</url>
    </required_header>
    <id_info>
      <org_study_id>2022-00921-02</org_study_id>
      <nct_id>NCT06009978</nct_id>
    </id_info>
    <brief_title>Effect of Additional Treatment With NMES After Achilles Tendon Rupture</brief_title>
    <official_title>The Effect of Early Treatment With Neuromuscular, Electrical Stimulation (NMES) After Achilles Tendon Rupture</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vastra Gotaland Region</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Göteborg University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Vastra Gotaland Region</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>
        Increased knowledge is needed about new methods how to treat patients with Achilles tendon&#xD;
        ruptures (ATR). A goal is to be able to individualize as well as improve treatment beyond the&#xD;
        question about if surgery should be used or not.&#xD;
  &#xD;
        An overall aim of the project is to, in a randomized controlled trial (RCT), explore what&#xD;
        impact a new treatment method with Neuromuscular Electrical Stimulation (NMES) - attached on&#xD;
        the patients ́ calf muscles on the injured leg - in the early stages after an ATR, may have&#xD;
        on tendon length, functional performance, biomechanical variables and patient reported&#xD;
        outcome, both in the short and long term after the injury. 70 patients are planned to be&#xD;
        included in this RCT and will be evaluated 3,6 and 12 months after their injury. Primary&#xD;
        outcome will be heel-rise height. Secondary outcome will be tendon length, jumping ability,&#xD;
        patient- reported outcome and biomechanical loading pattern.&#xD;
  &#xD;
        There is also a need to explore if the patients ́ loading patterns improve after treatment&#xD;
        with NMES. Therefore, biomechanical variables in lower leg during walking and jumping will&#xD;
        also be evaluated one year after their injury.&#xD;
  &#xD;
        The planned studies include completely new ways of exploring how to optimize the&#xD;
        rehabilitation after an ATR.&#xD;
  &#xD;
        Since there might be an increased risk for overuse injuries in the healthy limb, there will&#xD;
        also be focus on how the non- injured limb may be affected of an ATR.&#xD;
  &#xD;
        Taken together, this new knowledge can be helpful in the clinical setting to individualize&#xD;
        and optimize patients' treatment and rehabilitation with the goal to guide the patient return&#xD;
        to the same, or higher level of, physical activity as before the injury.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        BACKGROUND:&#xD;
  &#xD;
        There is limited knowledge about how calf muscle performance and tendon elongation affect the&#xD;
        patient's discomfort or ability to return to previous activity levels after an Achilles&#xD;
        Tendon rupture. Tendon elongation can cause a changed recruitment pattern of the different&#xD;
        parts of the muscle complex triceps surae. There is some evidence that treatment with&#xD;
        Neuromuscular Electrical Stimulation (NMES) can improve postural balance by stimulating the&#xD;
        calf muscles in elderly people with impaired balance. A newly published study concluded that&#xD;
        NMES treatment the first 12 weeks after an ATR, did not have any impact on calf circumference&#xD;
        or patient-reported outcome the first 12 weeks after the injury.&#xD;
  &#xD;
        Studies have shown that only 20-40% of patients are able to return to the same level of&#xD;
        physical activity as before the injury. Although patients return to full participation in&#xD;
        sports, their level of performance is often adversely affected. Obviously, there can be&#xD;
        different reasons for this. In a newly published study, it was concluded that joint power&#xD;
        distribution during a drop countermovement jump was affected by fear of reinjury as long as 2&#xD;
        years after an ATR. However, there is still a lot to explore about if an improved physical&#xD;
        function in the injured calf muscle may decrease the fear of re-injury and therefore&#xD;
        positively affect the ability to return to previous physical activity level after an ATR.&#xD;
        Therefore, new treatments with the goal to increase the possibility to return to the same&#xD;
        physical level as before the injury are very much needed.&#xD;
  &#xD;
        An ATR can lead to reduced strength development in the ankle with simultaneous increased load&#xD;
        development in the knee joint in the injured leg for as long as 6 years after the injury.&#xD;
        Reduction in strength and endurance in the calf muscle has been shown to persist long after&#xD;
        the injury. Exhaustion of the lower leg muscles affects the valgus moment in the knee as well&#xD;
        as kinematic variables in athletes during vertical jumps, which may affect the risk of knee&#xD;
        injury. However, there is a lack of knowledge about how lower leg function, biomechanics and&#xD;
        muscle recruitment are affected in patients after an ATR. It is also unknown how this injury&#xD;
        affects the healthy limb and perhaps increase the risk of overload injuries in other parts of&#xD;
        the body.&#xD;
  &#xD;
        HYPOTHESIS:&#xD;
  &#xD;
        Additional treatment with NMES in early stages after an Achilles Tendon rupture have a&#xD;
        positive impact on lower leg function both in the short and long term.&#xD;
  &#xD;
        PURPOSE AND SPECIFIC GOALS:&#xD;
  &#xD;
        An overall aim of the project is to, in a randomized controlled trial, explore what impact a&#xD;
        new treatment method with NMES in the early stages after an ATR may have on calf muscle&#xD;
        performance, tendon length, jumping ability, biomechanical variables and patient reported&#xD;
        outcome both in the short and long term after the injury.&#xD;
  &#xD;
        There will also be focus on how the non-injured limb may be affected of an Achilles tendon&#xD;
        rupture. This new knowledge can be helpful in the clinical setting to&#xD;
  &#xD;
          1. individualize and optimize patients' treatment and rehabilitation&#xD;
  &#xD;
          2. avoid overuse injuries, both in the injured and healthy limb The goal will be to guide&#xD;
             the patient return to the same, or higher level of physical activity as before the&#xD;
             injury.&#xD;
  &#xD;
        OBJECTIVES:&#xD;
  &#xD;
          -  To explore if additional treatment with NMES during the first 3-8 weeks after an ATR can&#xD;
             improve calf muscle function, biomechanical variables, tendon lengthening and&#xD;
             patient-reported outcome both in short an long term. The design of this study is a&#xD;
             Randomized Controlled Trial (RCT).&#xD;
  &#xD;
          -  To evaluate the biomechanics of the ankle, knee and hip during walking, running and&#xD;
             jumping in both limbs in two groups of patients one year after an ATR. One group has&#xD;
             been treated with NMES 3-8 weeks after the injury and the other group has not.&#xD;
  &#xD;
        METHOD The design of this study is a randomized controlled trial. A power calculation (p&#xD;
        &lt;0.05, power 80%) showed that 28 patients who receive and 28 who do not receive treatment&#xD;
        with NMES are needed to be able to show a clinically important difference of 10% in heel-rise&#xD;
        height. A total of 70 patients with ATR will be included and randomized to receive or to not&#xD;
        receive additional therapy with NMES during the first 3-8 weeks after their ATR.&#xD;
  &#xD;
        Four electrodes connected with the NMES equipment will be attached on the patients ́ calf on&#xD;
        the injured leg and they will use the equipment in their home two times a day á 15 minutes&#xD;
        for six weeks, that is 3-8 weeks after the injury.&#xD;
  &#xD;
        Primary outcome will be the heel-rise height during the heel-rise work test. Standardized&#xD;
        seated heel-rise as well as single-leg standing heel- rise will be evaluated 3, 6 and 12&#xD;
        months after the injury in both the injured and the healthy limb. The heel-rise work test&#xD;
        will be evaluated with a linear encoder connected to the software MuscleLab®.&#xD;
  &#xD;
        Tendon length will be evaluated with ultrasound 8 weeks and 3, 6 and 12 months after the&#xD;
        injury. The measurement is found to be reliable and valid. The tendon length will be&#xD;
        evaluated with ultrasonography with extended field of view using a wideband array linear&#xD;
        probe (5.0- 13.0 MHz). The B- mode at 10 MHz and a depth of 3 cm will be used to record the&#xD;
        images.&#xD;
  &#xD;
        One year after the injury, kinematic and kinetic variables together with EMG will be&#xD;
        evaluated during walking, running and jumping. For collection of the biomechanical data, 16&#xD;
        7+ cameras and 4 force plates will be used. This new equipment is available in a new motional&#xD;
        analysis lab at our research unit. Fifty-five reflectors will be attached on the patients´&#xD;
        body to be able to detect segmental movements. EMG electrodes on the medial and lateral&#xD;
        Gastrocnemius, Soleus and Tibialis anterior muscles will also be attached on the patient in&#xD;
        order to measure how the muscles are recruited in the different activities. Both healthy and&#xD;
        injured sides will be analyzed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Heel-rise height during heel-rise work test</measure>
      <time_frame>12 months</time_frame>
      <description>Evaluation of heel-rise height during heel-rise work test. Comparison between groups in heel-rise height Limb Symmetry Index (LSI) - injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heel-rise height during heel-rise work test</measure>
      <time_frame>6 months</time_frame>
      <description>Evaluation of heel-rise height during heel-rise work test. Comparison between groups in heel-rise height (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heel-rise height during heel-rise work test</measure>
      <time_frame>3 months</time_frame>
      <description>Evaluation of heel-rise height during heel-rise work test using. Comparison between groups in heel-rise height (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Tendon length</measure>
      <time_frame>12 months</time_frame>
      <description>Comparison between groups and limbs in Length measured with ultrasound from insertion to myotendinous junction in both limbs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tendon length</measure>
      <time_frame>6 months</time_frame>
      <description>Comparison between groups and limbs in Length measured with ultrasound from insertion to myotendinous junction in both limbs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tendon length</measure>
      <time_frame>3 months</time_frame>
      <description>Comparison between groups and limbs in Length measured with ultrasound from insertion to myotendinous junction in both limbs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastrocnemius Cross-sectional area</measure>
      <time_frame>12 months</time_frame>
      <description>Comparison between groups and limbs in Area of medial and lateral gastrocnemius in both limbs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastrocnemius Cross-sectional area</measure>
      <time_frame>6 months</time_frame>
      <description>Comparison between groups and limbs in Area of medial and lateral gastrocnemius in both limbs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastrocnemius Cross-sectional area</measure>
      <time_frame>3 months</time_frame>
      <description>Comparison between groups and limbs in Area of m medial and m lateral gastrocnemius in both limbs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soleus cross-sectional area</measure>
      <time_frame>12 months</time_frame>
      <description>Comparison between groups and limbs in Area of m soleus in both limbs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soleus cross-sectional area</measure>
      <time_frame>6 months</time_frame>
      <description>Comparison between groups and limbs in Area of m soleus in both limbs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soleus cross-sectional area</measure>
      <time_frame>3 months</time_frame>
      <description>Comparison between groups and limbs in Area of m soleus in both limbs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biomechanical data; kinematic data will be evaluated during walking, running and jumping.</measure>
      <time_frame>12 months</time_frame>
      <description>16 7+ cameras and 4 force plates will be used. 55 reflectors will be attached on the patients´body to be able to detect segmental movements. Kinematic data will be evaluated in degrees in ankle, knee and hip. Comparison will be performed between groups and limbs in degrees (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biomechanical data; kinetic data will be evaluated during walking, running and jumping.</measure>
      <time_frame>12 months</time_frame>
      <description>16 7+ cameras and 4 force plates will be used. 55 reflectors will be attached on the patients´body to be able to detect segmental movements. Kinetic data will be evaluated in power (watt) in ankle, knee and hip. Comparison will be performed between groups and limbs in power (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Electro Myography (EMG) will be evaluated during walking, running and jumping.</measure>
      <time_frame>12 months</time_frame>
      <description>EMG electrodes on the medial and lateral Gastrocnemius, Soleus and Tibialis anterior, Quadriceps and trunk muscles will be attached on the patient in order to measure how the muscles are recruited during walking running and jumping. Both healthy and injured sides will be analyzed. The electrical activity in the muscles will be evaluated. Comparison will be performed between groups and limbs in power (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Achilles tendon Total Rupture Score (ATRS)</measure>
      <time_frame>3 months</time_frame>
      <description>A valid and reliable questionnaire developed for patients with an Achilles Tendon rupture with a purpose to evaluate patient reported outcome in terms of symptoms and function. The values can be between 0 and 100 and the higher score, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Achilles tendon Total Rupture Score (ATRS)</measure>
      <time_frame>6 months</time_frame>
      <description>A valid and reliable questionnaire developed for patients with an Achilles Tendon rupture with a purpose to evaluate patient reported outcome in terms of symptoms and function.The values can be between 0 and 100 and the higher score, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Achilles tendon Total Rupture Score (ATRS)</measure>
      <time_frame>12 months</time_frame>
      <description>A valid and reliable questionnaire developed for patients with an Achilles Tendon rupture with a purpose to evaluate patient reported outcome in terms of symptoms and function.The values can be between 0 and 100 and the higher score, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Scale (PAS)</measure>
      <time_frame>12 months</time_frame>
      <description>A patient reported outcome used for the purpose to evaluate the patients self estimated physical activity level. The scale is from 1 to 6 and the higher score, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Scale (PAS)</measure>
      <time_frame>6 months</time_frame>
      <description>A patient reported outcome used for the purpose to evaluate the patients self estimated physical activity level.The scale is from 1 to 6 and the higher score, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Scale (PAS)</measure>
      <time_frame>3 months</time_frame>
      <description>A patient reported outcome used for the purpose to evaluate the patients self estimated physical activity level.The scale is from 1 to 6 and the higher score, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drop Countermovement Jump</measure>
      <time_frame>6 months</time_frame>
      <description>Drop Countermovement Jump: Evaluation of vertical jumping height after jumping from a 20 cm high box. The outcome will be measured as the height the patient can perform in jump height after landing in cm. Comparison between groups and limbs in jump height will be presented as Limb Symmetry Index (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drop Countermovement Jump</measure>
      <time_frame>12 months</time_frame>
      <description>Drop Countermovement Jump: Evaluation of vertical jumping height after jumping from a 20 cm high box. The outcome will be measured as the height the patient can perform in jump height after landing in cm. Comparison between groups and limbs in jump height will be presented as Limb Symmetry Index (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hopping</measure>
      <time_frame>6 months</time_frame>
      <description>Evaluation of series of jumps as in jumping ropes. The outcome measurement will be mean jumping height in cm and elasticity ratio in 20 jumps. Comparison between groups and limbs in jump height and elasticity ratio will be presented as Limb Symmetry Index (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hopping</measure>
      <time_frame>12 months</time_frame>
      <description>Evaluation of series of jumps as in jumping ropes. The outcome measurement will be mean jumping height in cm and elasticity ratio in 20 jumps. Comparison between groups and limbs in jump height and elasticity ratio will be presented as Limb Symmetry Index (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Calf muscle power</measure>
      <time_frame>6 months</time_frame>
      <description>Evaluation of calf muscle power in a weight training machine expressed in watt (Newton x meter /seconds). Comparison will be performed between groups and limbs in power (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Calf muscle power</measure>
      <time_frame>12 months</time_frame>
      <description>Evaluation of calf muscle power in a weight training machine expressed in watt (Newton x meter /seconds). Comparison will be performed between groups and limbs in power (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Achilles Tendon Rupture</condition>
    <condition>Physical Disability</condition>
    <arm_group>
      <arm_group_label>Additional treatment with NMES after Achilles Tendon rupture</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Neuromuscular electrical stimulation 2 times a day á 15 minutes during the week 3-8 after the Achilles Tendon rupture.&#xD;
  Patients will also follow ordinary standard rehabilitation for Achilles Tendon rupture</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients will follow ordinary standard rehabilitation for Achilles Tendon rupture</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Neuromuscular electrical stimulation (NMES)</intervention_name>
      <description>Neuromuscular electrical stimulation (NMES) 2 times a day á 15 minutes from the third to the eight week after injury. The additional treatment will be perform in the patients home by themselves</description>
      <arm_group_label>Additional treatment with NMES after Achilles Tendon rupture</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Achilles Tendon rupture&#xD;
  &#xD;
            -  The injury should have been treated within two days from the trauma&#xD;
  &#xD;
            -  The rupture is located in the mid portion of the tendon&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Having a pace maker, intra cardiac defibrillator or other active implant&#xD;
  &#xD;
            -  Having had an Achilles Tendon rupture before, regardless of side&#xD;
  &#xD;
            -  Having an earlier injury that will have an impact on lower leg function, regardless of&#xD;
               side&#xD;
  &#xD;
            -  Diabetes&#xD;
  &#xD;
            -  Neuro vascular disease&#xD;
  &#xD;
            -  Immunosuppressive treatment&#xD;
  &#xD;
            -  Difficulties to understand the language or difficulties in understand instructions.&#xD;
  &#xD;
            -  Unable to consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Katarina Nilsson Helander, Ass.Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>VGregion</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Katarina Nilsson Helander, Ass.prof.</last_name>
      <phone>+46 70-3218420</phone>
      <email>katarina.nilsson.helander@vgregion.se</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Annelie Brorsson, PhD</last_name>
      <phone>+46 70-4005508</phone>
      <email>annelie.brorsson@orthop.gu.se</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Forskningsenhet Ortopedi, Sahlgrenska universitetssjukhuset, Mölndal</name>
        <address>
          <city>Mölndal</city>
          <state>VGregion</state>
          <zip>43180</zip>
          <country>Sweden</country>
        </address>
      </facility>
      <contact>
        <last_name>Pernilla Eliasson, Ass.prof.</last_name>
        <phone>+46 73-9864982</phone>
        <email>pernilla.eliasson@vgregion.se</email>
      </contact>
      <contact_backup>
        <last_name>Roy Tranberg, Ass.prof</last_name>
        <phone>+46 70-8105401</phone>
        <email>roy.tranberg@vgregion.se</email>
      </contact_backup>
      <investigator>
        <last_name>Katarina Nilsson Helander, Ass.prof.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Annelie Brorsson, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Achilles Tendon Rupture</keyword>
    <keyword>Rehabilitation</keyword>
    <keyword>Neuromuscular Electrical Stimulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rupture</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06009978
  org study id: 2022-00921-02
  nct id: NCT06009978
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Increased knowledge is needed about new methods how to treat patients with Achilles tendon
        ruptures (ATR). A goal is to be able to individualize as well as improve treatment beyond the
        question about if surgery should be used or not.
  
        An overall aim of the project is to, in a randomized controlled trial (RCT), explore what
        impact a new treatment method with Neuromuscular Electrical Stimulation (NMES) - attached on
        the patients ́ calf muscles on the injured leg - in the early stages after an ATR, may have
        on tendon length, functional performance, biomechanical variables and patient reported
        outcome, both in the short and long term after the injury. 70 patients are planned to be
        included in this RCT and will be evaluated 3,6 and 12 months after their injury. Primary
        outcome will be heel-rise height. Secondary outcome will be tendon length, jumping ability,
        patient- reported outcome and biomechanical loading pattern.
  
        There is also a need to explore if the patients ́ loading patterns improve after treatment
        with NMES. Therefore, biomechanical variables in lower leg during walking and jumping will
        also be evaluated one year after their injury.
  
        The planned studies include completely new ways of exploring how to optimize the
        rehabilitation after an ATR.
  
        Since there might be an increased risk for overuse injuries in the healthy limb, there will
        also be focus on how the non- injured limb may be affected of an ATR.
  
        Taken together, this new knowledge can be helpful in the clinical setting to individualize
        and optimize patients' treatment and rehabilitation with the goal to guide the patient return
        to the same, or higher level of, physical activity as before the injury.
  BACKGROUND:
  
        There is limited knowledge about how calf muscle performance and tendon elongation affect the
        patient's discomfort or ability to return to previous activity levels after an Achilles
        Tendon rupture. Tendon elongation can cause a changed recruitment pattern of the different
        parts of the muscle complex triceps surae. There is some evidence that treatment with
        Neuromuscular Electrical Stimulation (NMES) can improve postural balance by stimulating the
        calf muscles in elderly people with impaired balance. A newly published study concluded that
        NMES treatment the first 12 weeks after an ATR, did not have any impact on calf circumference
        or patient-reported outcome the first 12 weeks after the injury.
  
        Studies have shown that only 20-40% of patients are able to return to the same level of
        physical activity as before the injury. Although patients return to full participation in
        sports, their level of performance is often adversely affected. Obviously, there can be
        different reasons for this. In a newly published study, it was concluded that joint power
        distribution during a drop countermovement jump was affected by fear of reinjury as long as 2
        years after an ATR. However, there is still a lot to explore about if an improved physical
        function in the injured calf muscle may decrease the fear of re-injury and therefore
        positively affect the ability to return to previous physical activity level after an ATR.
        Therefore, new treatments with the goal to increase the possibility to return to the same
        physical level as before the injury are very much needed.
  
        An ATR can lead to reduced strength development in the ankle with simultaneous increased load
        development in the knee joint in the injured leg for as long as 6 years after the injury.
        Reduction in strength and endurance in the calf muscle has been shown to persist long after
        the injury. Exhaustion of the lower leg muscles affects the valgus moment in the knee as well
        as kinematic variables in athletes during vertical jumps, which may affect the risk of knee
        injury. However, there is a lack of knowledge about how lower leg function, biomechanics and
        muscle recruitment are affected in patients after an ATR. It is also unknown how this injury
        affects the healthy limb and perhaps increase the risk of overload injuries in other parts of
        the body.
  
        HYPOTHESIS:
  
        Additional treatment with NMES in early stages after an Achilles Tendon rupture have a
        positive impact on lower leg function both in the short and long term.
  
        PURPOSE AND SPECIFIC GOALS:
  
        An overall aim of the project is to, in a randomized controlled trial, explore what impact a
        new treatment method with NMES in the early stages after an ATR may have on calf muscle
        performance, tendon length, jumping ability, biomechanical variables and patient reported
        outcome both in the short and long term after the injury.
  
        There will also be focus on how the non-injured limb may be affected of an Achilles tendon
        rupture. This new knowledge can be helpful in the clinical setting to
  
          1. individualize and optimize patients' treatment and rehabilitation
  
          2. avoid overuse injuries, both in the injured and healthy limb The goal will be to guide
             the patient return to the same, or higher level of physical activity as before the
             injury.
  
        OBJECTIVES:
  
          -  To explore if additional treatment with NMES during the first 3-8 weeks after an ATR can
             improve calf muscle function, biomechanical variables, tendon lengthening and
             patient-reported outcome both in short an long term. The design of this study is a
             Randomized Controlled Trial (RCT).
  
          -  To evaluate the biomechanics of the ankle, knee and hip during walking, running and
             jumping in both limbs in two groups of patients one year after an ATR. One group has
             been treated with NMES 3-8 weeks after the injury and the other group has not.
  
        METHOD The design of this study is a randomized controlled trial. A power calculation (p
        <0.05, power 80%) showed that 28 patients who receive and 28 who do not receive treatment
        with NMES are needed to be able to show a clinically important difference of 10% in heel-rise
        height. A total of 70 patients with ATR will be included and randomized to receive or to not
        receive additional therapy with NMES during the first 3-8 weeks after their ATR.
  
        Four electrodes connected with the NMES equipment will be attached on the patients ́ calf on
        the injured leg and they will use the equipment in their home two times a day á 15 minutes
        for six weeks, that is 3-8 weeks after the injury.
  
        Primary outcome will be the heel-rise height during the heel-rise work test. Standardized
        seated heel-rise as well as single-leg standing heel- rise will be evaluated 3, 6 and 12
        months after the injury in both the injured and the healthy limb. The heel-rise work test
        will be evaluated with a linear encoder connected to the software MuscleLab®.
  
        Tendon length will be evaluated with ultrasound 8 weeks and 3, 6 and 12 months after the
        injury. The measurement is found to be reliable and valid. The tendon length will be
        evaluated with ultrasonography with extended field of view using a wideband array linear
        probe (5.0- 13.0 MHz). The B- mode at 10 MHz and a depth of 3 cm will be used to record the
        images.
  
        One year after the injury, kinematic and kinetic variables together with EMG will be
        evaluated during walking, running and jumping. For collection of the biomechanical data, 16
        7+ cameras and 4 force plates will be used. This new equipment is available in a new motional
        analysis lab at our research unit. Fifty-five reflectors will be attached on the patients´
        body to be able to detect segmental movements. EMG electrodes on the medial and lateral
        Gastrocnemius, Soleus and Tibialis anterior muscles will also be attached on the patient in
        order to measure how the muscles are recruited in the different activities. Both healthy and
        injured sides will be analyzed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Heel-rise height during heel-rise work test
  time frame: 12 months
  description: Evaluation of heel-rise height during heel-rise work test. Comparison between groups in heel-rise height Limb Symmetry Index (LSI) - injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome
  measure: Heel-rise height during heel-rise work test
  time frame: 6 months
  description: Evaluation of heel-rise height during heel-rise work test. Comparison between groups in heel-rise height (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome
  measure: Heel-rise height during heel-rise work test
  time frame: 3 months
  description: Evaluation of heel-rise height during heel-rise work test using. Comparison between groups in heel-rise height (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome
  measure: Tendon length
  time frame: 12 months
  description: Comparison between groups and limbs in Length measured with ultrasound from insertion to myotendinous junction in both limbs.
  measure: Tendon length
  time frame: 6 months
  description: Comparison between groups and limbs in Length measured with ultrasound from insertion to myotendinous junction in both limbs.
  measure: Tendon length
  time frame: 3 months
  description: Comparison between groups and limbs in Length measured with ultrasound from insertion to myotendinous junction in both limbs.
  measure: Gastrocnemius Cross-sectional area
  time frame: 12 months
  description: Comparison between groups and limbs in Area of medial and lateral gastrocnemius in both limbs
  measure: Gastrocnemius Cross-sectional area
  time frame: 6 months
  description: Comparison between groups and limbs in Area of medial and lateral gastrocnemius in both limbs
  measure: Gastrocnemius Cross-sectional area
  time frame: 3 months
  description: Comparison between groups and limbs in Area of m medial and m lateral gastrocnemius in both limbs
  measure: Soleus cross-sectional area
  time frame: 12 months
  description: Comparison between groups and limbs in Area of m soleus in both limbs
  measure: Soleus cross-sectional area
  time frame: 6 months
  description: Comparison between groups and limbs in Area of m soleus in both limbs
  measure: Soleus cross-sectional area
  time frame: 3 months
  description: Comparison between groups and limbs in Area of m soleus in both limbs
  measure: Biomechanical data; kinematic data will be evaluated during walking, running and jumping.
  time frame: 12 months
  description: 16 7+ cameras and 4 force plates will be used. 55 reflectors will be attached on the patients´body to be able to detect segmental movements. Kinematic data will be evaluated in degrees in ankle, knee and hip. Comparison will be performed between groups and limbs in degrees (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome.
  measure: Biomechanical data; kinetic data will be evaluated during walking, running and jumping.
  time frame: 12 months
  description: 16 7+ cameras and 4 force plates will be used. 55 reflectors will be attached on the patients´body to be able to detect segmental movements. Kinetic data will be evaluated in power (watt) in ankle, knee and hip. Comparison will be performed between groups and limbs in power (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome.
  measure: Electro Myography (EMG) will be evaluated during walking, running and jumping.
  time frame: 12 months
  description: EMG electrodes on the medial and lateral Gastrocnemius, Soleus and Tibialis anterior, Quadriceps and trunk muscles will be attached on the patient in order to measure how the muscles are recruited during walking running and jumping. Both healthy and injured sides will be analyzed. The electrical activity in the muscles will be evaluated. Comparison will be performed between groups and limbs in power (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome.
  measure: Achilles tendon Total Rupture Score (ATRS)
  time frame: 3 months
  description: A valid and reliable questionnaire developed for patients with an Achilles Tendon rupture with a purpose to evaluate patient reported outcome in terms of symptoms and function. The values can be between 0 and 100 and the higher score, the better outcome.
  measure: Achilles tendon Total Rupture Score (ATRS)
  time frame: 6 months
  description: A valid and reliable questionnaire developed for patients with an Achilles Tendon rupture with a purpose to evaluate patient reported outcome in terms of symptoms and function.The values can be between 0 and 100 and the higher score, the better outcome.
  measure: Achilles tendon Total Rupture Score (ATRS)
  time frame: 12 months
  description: A valid and reliable questionnaire developed for patients with an Achilles Tendon rupture with a purpose to evaluate patient reported outcome in terms of symptoms and function.The values can be between 0 and 100 and the higher score, the better outcome.
  measure: Physical Activity Scale (PAS)
  time frame: 12 months
  description: A patient reported outcome used for the purpose to evaluate the patients self estimated physical activity level. The scale is from 1 to 6 and the higher score, the better outcome.
  measure: Physical Activity Scale (PAS)
  time frame: 6 months
  description: A patient reported outcome used for the purpose to evaluate the patients self estimated physical activity level.The scale is from 1 to 6 and the higher score, the better outcome.
  measure: Physical Activity Scale (PAS)
  time frame: 3 months
  description: A patient reported outcome used for the purpose to evaluate the patients self estimated physical activity level.The scale is from 1 to 6 and the higher score, the better outcome.
  measure: Drop Countermovement Jump
  time frame: 6 months
  description: Drop Countermovement Jump: Evaluation of vertical jumping height after jumping from a 20 cm high box. The outcome will be measured as the height the patient can perform in jump height after landing in cm. Comparison between groups and limbs in jump height will be presented as Limb Symmetry Index (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.
  measure: Drop Countermovement Jump
  time frame: 12 months
  description: Drop Countermovement Jump: Evaluation of vertical jumping height after jumping from a 20 cm high box. The outcome will be measured as the height the patient can perform in jump height after landing in cm. Comparison between groups and limbs in jump height will be presented as Limb Symmetry Index (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.
  measure: Hopping
  time frame: 6 months
  description: Evaluation of series of jumps as in jumping ropes. The outcome measurement will be mean jumping height in cm and elasticity ratio in 20 jumps. Comparison between groups and limbs in jump height and elasticity ratio will be presented as Limb Symmetry Index (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.
  measure: Hopping
  time frame: 12 months
  description: Evaluation of series of jumps as in jumping ropes. The outcome measurement will be mean jumping height in cm and elasticity ratio in 20 jumps. Comparison between groups and limbs in jump height and elasticity ratio will be presented as Limb Symmetry Index (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.
  measure: Calf muscle power
  time frame: 6 months
  description: Evaluation of calf muscle power in a weight training machine expressed in watt (Newton x meter /seconds). Comparison will be performed between groups and limbs in power (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome.
  measure: Calf muscle power
  time frame: 12 months
  description: Evaluation of calf muscle power in a weight training machine expressed in watt (Newton x meter /seconds). Comparison will be performed between groups and limbs in power (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome
  arm group label: Additional treatment with NMES after Achilles Tendon rupture
  arm group type: Active Comparator
  description: Neuromuscular electrical stimulation 2 times a day á 15 minutes during the week 3-8 after the Achilles Tendon rupture.
  Patients will also follow ordinary standard rehabilitation for Achilles Tendon rupture
  arm group label: Control group
  arm group type: No Intervention
  description: Patients will follow ordinary standard rehabilitation for Achilles Tendon rupture
  intervention type: Device
  intervention name: Neuromuscular electrical stimulation (NMES)
  description: Neuromuscular electrical stimulation (NMES) 2 times a day á 15 minutes from the third to the eight week after injury. The additional treatment will be perform in the patients home by themselves
  arm group label: Additional treatment with NMES after Achilles Tendon rupture
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Katarina Nilsson Helander, Ass.Prof
  role: Principal Investigator
  affiliation: VGregion
  last name: Katarina Nilsson Helander, Ass.prof.
  phone: +46 70-3218420
  email: katarina.nilsson.helander@vgregion.se
  last name: Annelie Brorsson, PhD
  phone: +46 70-4005508
  email: annelie.brorsson@orthop.gu.se
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Sweden
  responsible party type: Sponsor
  mesh term: Rupture
  sharing ipd: No