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/NCT06039904</url>
    </required_header>
    <id_info>
      <org_study_id>COA.MURA2021/292</org_study_id>
      <nct_id>NCT06039904</nct_id>
    </id_info>
    <brief_title>Protection of Knee Joints in Bleeding Disorder Patients</brief_title>
    <official_title>Comparison Between Natural Rubber Knee Support and Sponge Knee Support on the Protection of Knee Joint: A Crossover Randomized Controlled Study Among Patients With Bleeding Disorders</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ramathibodi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ramathibodi 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>
        INTRODUCTION Knee supports, usually made with sponge cushion, are used to protect knee joint&#xD;
        and prevent its injury. Sponge has less elasticity and durability compared with natural&#xD;
        rubber. To our knowledge, there has been no study regarding effectiveness of natural rubber&#xD;
        and sponge for knee joint protection and injury prevention in children with bleeding&#xD;
        disorders.&#xD;
  &#xD;
        AIMS The study aimed to compare the effectiveness and satisfaction between natural rubber and&#xD;
        sponge knee supports for knee joint protection among children with bleeding disorders METHODS&#xD;
        The study had three phases: 1) measurement of compression force, 2) fabrication of knee&#xD;
        supports, and 3) a randomized crossover trial. The supports were fabricated in 4 sizes, S, M,&#xD;
        L, and XL. They comprised two parts: body, made from stretchable cotton; and cushion&#xD;
        (protection part), made from either natural rubber or sponge. The trial included 8 weeks of&#xD;
        alternatively wearing natural rubber knee support and sponge knee support with a 4-week&#xD;
        wash-out period. Numbers of knee bleeds and satisfied users were recorded.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study employed a prospective design, conducted at the Faculty of Medicine Ramathibodi&#xD;
        Hospital, a tertiary care hospital in Thailand, from April 2021 to September 2022; and&#xD;
        approved by the Hospital's Committee on Human Rights Related to Research Involving Human&#xD;
        Subjects (COA. MURA2021/292). Written informed consents were obtained from individual&#xD;
        patients and their legal guardians. The study was divided into three phases: measurement of&#xD;
        transmitted impact force, fabrication of knee supports, and randomized cross-over trial of&#xD;
        natural rubber and sponge knee supports.&#xD;
  &#xD;
        Phase I: Transmitted impact forces were measured using an impact tester (Model DC Power&#xD;
        Supply GW Instek GPS-30300 and Multi-Meter Fluke DT-9208a). Three types of knee support&#xD;
        samples, size 30 x 30 x 1 cm (W x L x H), were prepared: with no barrier, with natural rubber&#xD;
        cushion, and with sponge cushion and tested. The test was performed using the same force in&#xD;
        the ballistic pendulum test (1 kg momentum ball with a radius of 50 cm). The test was&#xD;
        repeated three times, and the average results were recorded as force (Newton) and time (sec)&#xD;
        after the sphere hit the receptive sensor. Natural rubber used in this study was made from&#xD;
        natural rubber and polymer (Patent ID 74814).&#xD;
  &#xD;
        Phase II: Knee supports were designed and fabricated in various sizes. Three measurements,&#xD;
        knee circumferences, patella sizes, and knee heights, were taken from 20 Thai children aged&#xD;
        between 9 months and 10 years and having body weights within the 50th to 75th percentile. The&#xD;
        knee support comprised two parts, the support body and the protective cushion. The width of&#xD;
        the support body was derived from half of the knee circumference, and the length was taken&#xD;
        from 80% of the knee height, measured from knee to medial malleolus. From those measurements,&#xD;
        final knee supports were categorized into four sizes, S, M, L and XL according to widths and&#xD;
        lengths, as follows: size S, 8x17 cm; size M, 10x19 cm; size L, 12x24 cm; and size XL, 14x28&#xD;
        cm. The support body was made of stretchable natural cotton fabrics, which were comfortable,&#xD;
        breathable, washable, less irritant and flexible.22 Similarly, the protective cushion was&#xD;
        classified into four sizes: S, M, L and XL with diameters (based on the patellar diameters)&#xD;
        of 5, 6, 7 and 8 cm, respectively. Cushions were made from either natural rubber or sponge&#xD;
        and inserted at the front of the support body (to cover the patellar). As a result, natural&#xD;
        rubber and sponge knee supports were fabricated, and they both had similar external&#xD;
        appearance.&#xD;
  &#xD;
        Phase III: A randomized cross-over trial using natural rubber and sponge knee supports was&#xD;
        conducted among patients with bleeding disorders. The patients were divided into two groups,&#xD;
        A and B, by computer-generated randomization sequence using a box of ten. A total of 44&#xD;
        patients were enrolled with 21 in Group A and the other 23 in Group B. Later, two patients in&#xD;
        Group A were excluded due to loss of follow-ups. Therefore, the final number of patients in&#xD;
        the study was 42 with 19 in Group A and 23 in Group B. Group A was first assigned to&#xD;
        Treatment I of natural rubber knee support followed by Treatment II of sponge knee support,&#xD;
        while Group B was first assigned to Treatment II followed by Treatment I. Patients were&#xD;
        advised to use the supports during physical activities; for example, walking and crawling&#xD;
        among toddlers and playing sports among school-aged children. Each treatment covered a period&#xD;
        of eight weeks, with four weeks of wash-out period of cross-over from the first treatment to&#xD;
        the second. Survey data on demographics, number of bleeds, types of bleeding (extraarticular&#xD;
        or intraarticular), and user's satisfaction were collected. User's compliance and bleeding&#xD;
        data, including severity and activity when injury occurred, were collected weekly using&#xD;
        freeware application, online electronic form, or direct telephone contact. Satisfaction&#xD;
        survey was conducted following the Client Satisfaction with Device module of Orthotics and&#xD;
        Prosthetic User' Survey (CSD-OPUS)24 with Thai translation. The survey consisted of nine&#xD;
        aspects: fitting well, weight, comfort, ease to use, attractiveness, durability, irritation,&#xD;
        pain, and overall satisfaction. Patients aged &gt;7 years and all parents were included in the&#xD;
        survey, sent to them in electronic format, twice; i.e., at the end of the two treatments.&#xD;
        Scores were graded in absolutely agree, agree, disagree, and absolutely disagree. At the end&#xD;
        of the second treatment, parents of both groups were asked to choose either the knee support&#xD;
        of Treatment I or Treatment II as a preference.&#xD;
  &#xD;
        Patients The inclusion criteria were bleeding disorder patients, aged 9 months to 12 years&#xD;
        old, with written consents The enrolled patients had no coexisting diseases affecting their&#xD;
        activities, or bleeding episodes two weeks before the study. Children or parents who were not&#xD;
        able to continue the study until the end were excluded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 8, 2021</start_date>
    <completion_date type="Actual">September 1, 2022</completion_date>
    <primary_completion_date type="Actual">April 1, 2022</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>Randomized crossover trial</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of knee bleeding</measure>
      <time_frame>8 weeks</time_frame>
      <description>Number of intra and extraarticular knee bleedings</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">44</enrollment>
    <condition>Bleeding Disorder</condition>
    <condition>Knee Injuries</condition>
    <condition>Hemophilia</condition>
    <arm_group>
      <arm_group_label>Arm A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Arm A was first assigned to Treatment I of natural rubber knee support followed by Treatment II of sponge knee support</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Arm B was first assigned to Treatment II of sponge knee support followed by Treatment I of natural rubber knee support</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Natural rubber knee support</intervention_name>
      <description>The knee support comprised two parts, the support body and the protective cushion. Which were categorized into four sizes, S, M, L and XL according to widths and lengths, as follows: size S, 8x17 cm; size M, 10x19 cm; size L, 12x24 cm; and size XL, 14x28 cm. The support body was made of stretchable natural cotton fabrics, which were comfortable, breathable, washable, less irritant and flexible. Similarly, the protective cushion was classified into four sizes: S, M, L and XL with diameters (based on the patellar diameters) of 5, 6, 7 and 8 cm, respectively. Cushions were made from either natural rubber and inserted at the front of the support body (to cover the patellar).</description>
      <arm_group_label>Arm A</arm_group_label>
      <other_name>Sponge knee support</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sponge knee support</intervention_name>
      <description>The knee support comprised two parts, the support body and the protective cushion. Which were categorized into four sizes, S, M, L and XL according to widths and lengths, as follows: size S, 8x17 cm; size M, 10x19 cm; size L, 12x24 cm; and size XL, 14x28 cm. The support body was made of stretchable natural cotton fabrics, which were comfortable, breathable, washable, less irritant and flexible. Similarly, the protective cushion was classified into four sizes: S, M, L and XL with diameters (based on the patellar diameters) of 5, 6, 7 and 8 cm, respectively. Cushions were made from either sponge and inserted at the front of the support body (to cover the patellar).</description>
      <arm_group_label>Arm B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  bleeding disorder patients, aged 9 months to 12 years old, with written consents&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  coexisting diseases affecting their activities, or bleeding episodes two weeks before&#xD;
               the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>9 Months</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Supicha Maneekhiew</name>
        <address>
          <city>Bangkok</city>
          <zip>10220</zip>
          <country>Thailand</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Thailand</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ramathibodi Hospital</investigator_affiliation>
      <investigator_full_name>Nongnuch Sirachainan</investigator_full_name>
      <investigator_title>Prof</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemostatic Disorders</mesh_term>
      <mesh_term>Blood Coagulation Disorders</mesh_term>
      <mesh_term>Hemorrhagic Disorders</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
      <mesh_term>Knee Injuries</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/NCT06039904
  org study id: COA.MURA2021/292
  nct id: NCT06039904
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  INTRODUCTION Knee supports, usually made with sponge cushion, are used to protect knee joint
        and prevent its injury. Sponge has less elasticity and durability compared with natural
        rubber. To our knowledge, there has been no study regarding effectiveness of natural rubber
        and sponge for knee joint protection and injury prevention in children with bleeding
        disorders.
  
        AIMS The study aimed to compare the effectiveness and satisfaction between natural rubber and
        sponge knee supports for knee joint protection among children with bleeding disorders METHODS
        The study had three phases: 1) measurement of compression force, 2) fabrication of knee
        supports, and 3) a randomized crossover trial. The supports were fabricated in 4 sizes, S, M,
        L, and XL. They comprised two parts: body, made from stretchable cotton; and cushion
        (protection part), made from either natural rubber or sponge. The trial included 8 weeks of
        alternatively wearing natural rubber knee support and sponge knee support with a 4-week
        wash-out period. Numbers of knee bleeds and satisfied users were recorded.
  The study employed a prospective design, conducted at the Faculty of Medicine Ramathibodi
        Hospital, a tertiary care hospital in Thailand, from April 2021 to September 2022; and
        approved by the Hospital's Committee on Human Rights Related to Research Involving Human
        Subjects (COA. MURA2021/292). Written informed consents were obtained from individual
        patients and their legal guardians. The study was divided into three phases: measurement of
        transmitted impact force, fabrication of knee supports, and randomized cross-over trial of
        natural rubber and sponge knee supports.
  
        Phase I: Transmitted impact forces were measured using an impact tester (Model DC Power
        Supply GW Instek GPS-30300 and Multi-Meter Fluke DT-9208a). Three types of knee support
        samples, size 30 x 30 x 1 cm (W x L x H), were prepared: with no barrier, with natural rubber
        cushion, and with sponge cushion and tested. The test was performed using the same force in
        the ballistic pendulum test (1 kg momentum ball with a radius of 50 cm). The test was
        repeated three times, and the average results were recorded as force (Newton) and time (sec)
        after the sphere hit the receptive sensor. Natural rubber used in this study was made from
        natural rubber and polymer (Patent ID 74814).
  
        Phase II: Knee supports were designed and fabricated in various sizes. Three measurements,
        knee circumferences, patella sizes, and knee heights, were taken from 20 Thai children aged
        between 9 months and 10 years and having body weights within the 50th to 75th percentile. The
        knee support comprised two parts, the support body and the protective cushion. The width of
        the support body was derived from half of the knee circumference, and the length was taken
        from 80% of the knee height, measured from knee to medial malleolus. From those measurements,
        final knee supports were categorized into four sizes, S, M, L and XL according to widths and
        lengths, as follows: size S, 8x17 cm; size M, 10x19 cm; size L, 12x24 cm; and size XL, 14x28
        cm. The support body was made of stretchable natural cotton fabrics, which were comfortable,
        breathable, washable, less irritant and flexible.22 Similarly, the protective cushion was
        classified into four sizes: S, M, L and XL with diameters (based on the patellar diameters)
        of 5, 6, 7 and 8 cm, respectively. Cushions were made from either natural rubber or sponge
        and inserted at the front of the support body (to cover the patellar). As a result, natural
        rubber and sponge knee supports were fabricated, and they both had similar external
        appearance.
  
        Phase III: A randomized cross-over trial using natural rubber and sponge knee supports was
        conducted among patients with bleeding disorders. The patients were divided into two groups,
        A and B, by computer-generated randomization sequence using a box of ten. A total of 44
        patients were enrolled with 21 in Group A and the other 23 in Group B. Later, two patients in
        Group A were excluded due to loss of follow-ups. Therefore, the final number of patients in
        the study was 42 with 19 in Group A and 23 in Group B. Group A was first assigned to
        Treatment I of natural rubber knee support followed by Treatment II of sponge knee support,
        while Group B was first assigned to Treatment II followed by Treatment I. Patients were
        advised to use the supports during physical activities; for example, walking and crawling
        among toddlers and playing sports among school-aged children. Each treatment covered a period
        of eight weeks, with four weeks of wash-out period of cross-over from the first treatment to
        the second. Survey data on demographics, number of bleeds, types of bleeding (extraarticular
        or intraarticular), and user's satisfaction were collected. User's compliance and bleeding
        data, including severity and activity when injury occurred, were collected weekly using
        freeware application, online electronic form, or direct telephone contact. Satisfaction
        survey was conducted following the Client Satisfaction with Device module of Orthotics and
        Prosthetic User' Survey (CSD-OPUS)24 with Thai translation. The survey consisted of nine
        aspects: fitting well, weight, comfort, ease to use, attractiveness, durability, irritation,
        pain, and overall satisfaction. Patients aged >7 years and all parents were included in the
        survey, sent to them in electronic format, twice; i.e., at the end of the two treatments.
        Scores were graded in absolutely agree, agree, disagree, and absolutely disagree. At the end
        of the second treatment, parents of both groups were asked to choose either the knee support
        of Treatment I or Treatment II as a preference.
  
        Patients The inclusion criteria were bleeding disorder patients, aged 9 months to 12 years
        old, with written consents The enrolled patients had no coexisting diseases affecting their
        activities, or bleeding episodes two weeks before the study. Children or parents who were not
        able to continue the study until the end were excluded.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Randomized crossover trial
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Number of knee bleeding
  time frame: 8 weeks
  description: Number of intra and extraarticular knee bleedings
  arm group label: Arm A
  arm group type: Experimental
  description: Arm A was first assigned to Treatment I of natural rubber knee support followed by Treatment II of sponge knee support
  arm group label: Arm B
  arm group type: Experimental
  description: Arm B was first assigned to Treatment II of sponge knee support followed by Treatment I of natural rubber knee support
  intervention type: Device
  intervention name: Natural rubber knee support
  description: The knee support comprised two parts, the support body and the protective cushion. Which were categorized into four sizes, S, M, L and XL according to widths and lengths, as follows: size S, 8x17 cm; size M, 10x19 cm; size L, 12x24 cm; and size XL, 14x28 cm. The support body was made of stretchable natural cotton fabrics, which were comfortable, breathable, washable, less irritant and flexible. Similarly, the protective cushion was classified into four sizes: S, M, L and XL with diameters (based on the patellar diameters) of 5, 6, 7 and 8 cm, respectively. Cushions were made from either natural rubber and inserted at the front of the support body (to cover the patellar).
  arm group label: Arm A
  other name: Sponge knee support
  intervention type: Device
  intervention name: Sponge knee support
  description: The knee support comprised two parts, the support body and the protective cushion. Which were categorized into four sizes, S, M, L and XL according to widths and lengths, as follows: size S, 8x17 cm; size M, 10x19 cm; size L, 12x24 cm; and size XL, 14x28 cm. The support body was made of stretchable natural cotton fabrics, which were comfortable, breathable, washable, less irritant and flexible. Similarly, the protective cushion was classified into four sizes: S, M, L and XL with diameters (based on the patellar diameters) of 5, 6, 7 and 8 cm, respectively. Cushions were made from either sponge and inserted at the front of the support body (to cover the patellar).
  arm group label: Arm B
  criteria: 
  gender: All
  minimum age: 9 Months
  maximum age: 12 Years
  healthy volunteers: No
  facility: 
  country: Thailand
  responsible party type: Principal Investigator
  investigator affiliation: Ramathibodi Hospital
  investigator full name: Nongnuch Sirachainan
  investigator title: Prof
  mesh term: Hemostatic Disorders
  mesh term: Blood Coagulation Disorders
  mesh term: Hemorrhagic Disorders
  mesh term: Hemorrhage
  mesh term: Knee Injuries
  sharing ipd: No