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/NCT06033885</url>
    </required_header>
    <id_info>
      <org_study_id>11.928</org_study_id>
      <nct_id>NCT06033885</nct_id>
    </id_info>
    <brief_title>User Satisfaction of an Instrumented Standing Frame</brief_title>
    <official_title>Changes in User Satisfaction and Quality of Life Following 4 Weeks of Instrumented Standing Frame Intervention in Children With Disabilities - a Feasibility Intervention Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Southern Denmark</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>R82 A/S</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Innovation Fund Denmark</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Southern Denmark</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>
        Standing frames have existed for a long time and are well-established medical devices used to&#xD;
        allow weight bearing in standing for persons who are unable to stand independently.&#xD;
  &#xD;
        Documenting the effectiveness of interventions using standing frames is complex. The current&#xD;
        evidence base for their use is limited due to studies of low to moderate quality and small&#xD;
        effects documented.&#xD;
  &#xD;
        Providing real-time feed-back on force and position and thus continuous tracking of the&#xD;
        intensity allows for informed decision making about the support provided by the standing&#xD;
        frame in clinical settings, thereby making it possible to document the potential setup for&#xD;
        optimal support and potential association between the intensity and positive effects of the&#xD;
        standing frames.&#xD;
  &#xD;
        The objective of the study is to document potential short-term benefits on a) patient&#xD;
        satisfaction and health-related quality of life and b) changes in prescription from the&#xD;
        prescribing therapist of the use of standing frames in children with standing disabilities&#xD;
        when PONDUS®, a digital product used to assess the force applied during standing in a R82&#xD;
        standing frame is applied opposed to current practice.&#xD;
  &#xD;
        The study is a one-arm feasibility intervention study using participants as their own&#xD;
        controls. The study will include 15 children with functional disabilities who currently uses&#xD;
        a standing frame.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Most children stand independently by the age of 11 month, allowing them to apply different&#xD;
        loads on their bones, joints, and muscles, and experience their surroundings from a new&#xD;
        perspective (1-2). Children who do not reach the motor milestone &quot;standing&quot; in early&#xD;
        childhood should have access to assistive medical devices such as standing frames, which&#xD;
        enable them to gain benefits of the standing position as typically developing children (3).&#xD;
  &#xD;
        Standing frames have existed for a long time and are well-established medical devices used to&#xD;
        allow weight bearing in standing for persons who are unable to stand independently. The frame&#xD;
        supports the child with upholstered plates and straps around the legs, trunk and/or head and&#xD;
        is often positioned in an almost vertical posture, allowing the user partial weight bearing&#xD;
        on their lower extremities. The devices are widely used as part of postural management for&#xD;
        persons with disability (4-5) and a population-based study in Sweden shows that 31% of all&#xD;
        children with cerebral palsy use external support to stand (6).&#xD;
  &#xD;
        Documenting the effectiveness of interventions using standing frames is complex. The current&#xD;
        evidence base for their use is limited due to studies of low to moderate quality and small&#xD;
        effects documented (5, 7, 8-17). A systematic review (5) and recent studies on the potential&#xD;
        benefits of using standing frames indicate improvements in a range of functions and&#xD;
        activities including: mental functions (7), bone and joint development and health (8-12),&#xD;
        cardiovascular and respiratory systems, digestive systems and urinary functions (7-8),&#xD;
        neuromusculoskeletal and movement related functions, pain (7-8), mobility (13), the ability&#xD;
        to maintain a sitting or standing position (14-16), and major life areas, including&#xD;
        interaction with peers (5, 17). Importantly, the studies did not report adverse events or&#xD;
        serious harm.&#xD;
  &#xD;
        The above studies reveal a large variety in dosing in terms of frequency and time of use of&#xD;
        the standing frames from &lt;1 to 7 days per week, 1 or more sessions per day and &lt;30 min to&#xD;
        &gt;120 min per session (5). Importantly, none of the studies document dosing in terms of&#xD;
        intensity assessed as the degree of weight bearing while using a standing frame. Multiple&#xD;
        variables such as type of frame, use of supports, inclination, activities performed while&#xD;
        standing and inclination of the frame have been suggested to affect weight bearing in&#xD;
        standing frames (18). Instrumented standing frames have been used in experimental settings&#xD;
        and have documented a large variation in percentage of body weight from 23-133%, which could&#xD;
        indicate serious issues of controlling the intensity or even misuse and/or measurement error&#xD;
        (18-20). To our knowledge, instrumented standing frames that can assess force and position&#xD;
        during the use of a standing frames is currently not available for use in clinical practice.&#xD;
  &#xD;
        The lack of information about force and position during the use of standing frames in&#xD;
        clinical settings makes it impossible to document the potential setup for optimal support and&#xD;
        potential association between the intensity and positive effects of the standing frames and,&#xD;
        moreover, whether the intensity of the intervention should be tailored to the individual&#xD;
        child.&#xD;
  &#xD;
        Providing real-time feed-back on force and position and thus continuous tracking of the&#xD;
        intensity allows for informed decision making about the support provided by the standing&#xD;
        frame in a clinical setting.&#xD;
  &#xD;
        The purpose of this study is to document potential short-term benefits on a) patient&#xD;
        satisfaction and health-related quality of life and b) changes in prescription from the&#xD;
        prescribing therapist of the use of standing frames in children with standing disabilities&#xD;
        when PONDUS®, a digital product used to assess the force applied during standing in a R82&#xD;
        standing frame, is applied opposed to current practice.&#xD;
  &#xD;
        The study is a one-arm feasibility intervention study using participants as their own&#xD;
        controls. The study will be conducted in special day-care centers and schools or in the&#xD;
        children's home. Participants will be 15 children with functional disabilities in the age of&#xD;
        3-17 years who currently uses a standing frame.&#xD;
  &#xD;
        Recruitment will be conducted in collaboration with the study's commercial partner's&#xD;
        distributor network and special day-care centers and schools across Denmark, that will assist&#xD;
        in identifying possible study participants. In addition to the above parents will be reached&#xD;
        through advocacy organizations or on social medias with an invitation for participation in&#xD;
        the studies.&#xD;
  &#xD;
        Prior to the intervention a 4-week control period, where the non-instrumented standing frame&#xD;
        is used according to standard practice, will be carried out. Subsequently, a 4-week&#xD;
        intervention period, where the standing frame is instrumented (PONDUS®) allowing continued&#xD;
        monitoring and adjustments of the force and position during sessions will be conducted.&#xD;
        Changes in outcome measures will be evaluated as the difference in within-group change score&#xD;
        between the control period and intervention period.&#xD;
  &#xD;
        Participation in the study will be voluntary and all participants will be informed that even&#xD;
        after the eventual acceptance of participation, at any stage of the project they may decide&#xD;
        to discontinue participation in the trial without giving any reason and without it having&#xD;
        consequences for further treatment.&#xD;
  &#xD;
          1. WHO Multicentre Growth Reference Study (2006) WHO Motor Development Study: Windows of&#xD;
             achievement for six gross motor development milestones, Acta Paediatrica, 2006; Suppl.&#xD;
             450:86-95.&#xD;
  &#xD;
          2. Wijnhovet et al (2004) Assessment of gross motor development in the WHO Multicentre&#xD;
             Growth Reference Study, Food and Nutrition Bulletin 25,1 (supp. 1)&#xD;
  &#xD;
          3. WHO Early childhood development and disability Early childhood development and&#xD;
             disability: discussion paper. ISBN 9789241504065&#xD;
  &#xD;
          4. Goodwin J, Lecouturier J, Smith J, Crombie S, Basu A, Parr JR, Howel D, McColl E,&#xD;
             Roberts A, Miller K, Cadwgan J. Understanding frames: A qualitative exploration of&#xD;
             standing frame use for young people with cerebral palsy in educational settings. Child&#xD;
             Care Health Dev. 2019 May;45(3):433-439. doi: 10.1111/cch.12659.&#xD;
  &#xD;
          5. Paleg GS, Smith BA, Glickman LB. Systematic review and evidence-based clinical&#xD;
             recommendations for dosing of pediatric supported standing programs. Pediatr Phys Ther.&#xD;
             2013 Fall;25(3):232-47. doi: 10.1097/PEP.0b013e318299d5e7.&#xD;
  &#xD;
          6. Rodby-Bousquet E, Hägglund G. Sitting and standing performance in a total population of&#xD;
             children with cerebral palsy: a cross-sectional study. BMC Musculoskelet Disord.&#xD;
             2010;11:131. Published 2010 Jun 23. Doi:10.1186/1471-2474-11-131&#xD;
  &#xD;
          7. Rivi E, Filippi M, Fornasari E, Mascia MT, Ferrari A, Costi S. Effectiveness of standing&#xD;
             frame on constipation in children with cerebral palsy: a single-subject study. Occup&#xD;
             Ther Int. 2014 Sep;21(3):115-23. doi: 10.1002/oti.1370.&#xD;
  &#xD;
          8. Capati V, Covert SY, Paleg G. Stander use for an adolescent with cerebral palsy at GMFCS&#xD;
             level V with hip and knee contractures. Assist Technol. 2019 Apr 4:1-7. doi:&#xD;
             10.1080/10400435.2019.1579268.&#xD;
  &#xD;
          9. Han EY, Choi JH, Kim SH, Im SH. The effect of weight bearing on bone mineral density and&#xD;
             bone growth in children with cerebral palsy: A randomized controlled preliminary trial.&#xD;
             Medicine (Baltimore). 2017 Mar;96(10):e5896. doi: 10.1097/MD.0000000000005896.&#xD;
  &#xD;
         10. Macias-Merlo L, Bagur-Calafat C, Girabent-Farrés M, A Stuberg W. Effects of the standing&#xD;
             program with hip abduction on hip acetabular development in children with spastic&#xD;
             diplegia cerebral palsy. Disabil Rehabil. 2016;38(11):1075-81. doi:&#xD;
             0.3109/09638288.2015.1100221.&#xD;
  &#xD;
         11. Macias-Merlo L, Bagur-Calafat C, Girabent-Farrés M, Stuberg WA. Standing Programs to&#xD;
             Promote Hip Flexibility in Children With Spastic Diplegic Cerebral Palsy. Pediatr Phys&#xD;
             Ther. 2015 Fall;27(3):243-9. doi: 10.1097/PEP.0000000000000150.&#xD;
  &#xD;
         12. Hough JP, Boyd RN, Keating JL. Systematic review of interventions for low bone mineral&#xD;
             density in children with cerebral palsy. Pediatrics. 2010;125(3):e670-e678.&#xD;
             Doi:10.1542/peds.2009-0292&#xD;
  &#xD;
         13. Salem Y, Lovelace-Chandler V, Zabel RJ, McMillan AG. Effects of prolonged standing on&#xD;
             gait in children with spastic cerebral palsy. Phys Occup Ther Pediatr. 2010;30(1):54-65.&#xD;
             doi:10.3109/01942630903297177&#xD;
  &#xD;
         14. Curtis DJ, Woollacott M, Bencke J, et al. The functional effect of segmental trunk and&#xD;
             head control training in moderate-to-severe cerebral palsy: A randomized controlled&#xD;
             trial. Dev Neurorehabil. 2018;21(2):91-100. Doi:10.1080/17518423.2016.1265603&#xD;
  &#xD;
         15. Curtis DJ, Butler P, Saavedra S, et al. The central role of trunk control in the gross&#xD;
             motor function of children with cerebral palsy: a retrospective cross-sectional study.&#xD;
             Dev Med Child Neurol. 2015;57(4):351-357. Doi:10.1111/dmcn.12641.&#xD;
  &#xD;
         16. George F, A case series exploring static and dynamic posture: how making static&#xD;
             equipment dynamic may improve movement and function of children with neurological&#xD;
             impairment. APCP Journal 2018;9:56-63&#xD;
  &#xD;
         17. Pedlow_K, McDonough_S, Lennon_S, Kerr_C, Bradbury_I. Assisted standing for Duchenne&#xD;
             muscular dystrophy. Cochrane Database of Systematic Reviews 2019, Issue 10. Art. No.:&#xD;
             CD011550. DOI: 10.1002/14651858.CD011550.pub2.&#xD;
  &#xD;
         18. Paleg G, Altizer W, Malone R, Ballard K, Kreger A. Inclination, hip abduction,&#xD;
             orientation, and tone affect weight-bearing in standing devices. J Pediatr Rehabil Med.&#xD;
             2021 May 28. doi: 10.3233/PRM-190660. Epub ahead of print. PMID: 34057103.&#xD;
  &#xD;
         19. Herman D, May R, Vogel L, Johnson J, Henderson RC. Quantifying weight-bearing by&#xD;
             children with cerebral palsy while in passive standers. Pediatr Phys Ther 2007;19:283-7&#xD;
  &#xD;
         20. Kecskemethy HH, Herman D, May R, Paul K, Bachrach SJ, Henderson RC. Quantifying weight&#xD;
             bearing while in passive standers and a comparison of standers. Dev Med Child Neurol.&#xD;
             2008 Jul;50(7):520-3. doi: 10.1111/j.1469-8749.2008.03021.x. PMID: 18611202.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient satisfaction with an instrumented standing frame</measure>
      <time_frame>8 weeks difference in change score between the control period and intervention period</time_frame>
      <description>Patient satisfaction with an instrumented standing frame will be assessed with the Quebec User Evaluation of Satisfaction with Assistive Technology (Quest 2.0) questionnaires eight items assessing characteristics of the assistive device in terms of the following dimensions: 1) dimensions (size), 2. weight, 3. adjustments, 4. safety, 5. durability, 6. simplicity of use, 7. comfort and 8. effectiveness</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The three most important aspects of patient satisfaction with an instrumented standing frame</measure>
      <time_frame>8 weeks difference in change score between the control period and intervention period</time_frame>
      <description>Through user involvement, the three key aspects of patient satisfaction with an instrumented standing frame will be selected from the Quebec User Evaluation of Satisfaction with Assistive Technology (Quest 2.0) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Usability of an instrumented standing frame</measure>
      <time_frame>8 weeks difference in change score between the control period and intervention period</time_frame>
      <description>Usability of an instrumented standing frame will be assessed with the Usefulness, Satisfaction, and Ease of use (USE) Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>8 weeks difference in change score between the control period and intervention period</time_frame>
      <description>Health-related quality of life will be assessed with the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in prescription from the prescribing therapist</measure>
      <time_frame>8 weeks difference in change score between the control period and intervention period</time_frame>
      <description>Changes in prescription from the prescribing therapist of the use of the standing frame when PONDUS® is applied opposed to current practice will be assessed with a self-constructed questionnaire made for the purpose</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Patient satisfaction with assistive device service of an instrumented standing frame</measure>
      <time_frame>8 weeks difference in change score between the control period and intervention period</time_frame>
      <description>Patient satisfaction with assistive device service of an instrumented standing frame will be assessed with the Quebec User Evaluation of Satisfaction with Assistive Technology (Quest 2.0) questionnaires four items assessing characteristics of service in terms of the following dimensions: 1. service delivery, 2. repairs and service of the device, 3. professionalism of service and 4. follow-up service</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient satisfaction with PONDUS®</measure>
      <time_frame>4 weeks score from the intervention period</time_frame>
      <description>Patient satisfaction with PONDUS® will be assessed with the Quebec User Evaluation of Satisfaction with Assistive Technology (Quest 2.0) questionnaire</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Functional Disability</condition>
    <arm_group>
      <arm_group_label>4-week control period + 4-week intervention period</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Prior to the intervention a 4-week control period, where the non-instrumented standing frame is used according to current practice, will be carried out. Subsequently, a 4-week intervention period, where the standing frame is instrumented (PONDUS®) allowing continued adjustments of the force and position within and between sessions will be conducted.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PONDUS®</intervention_name>
      <description>PONDUS® is a CE-marked medical device to support the positioning of the user in a R82 standing frame.&#xD;
  PONDUS® is designed as a pair of instrumented foot plates and an app as an external display.&#xD;
  PONDUS® gives individual readings from the right and the left plate telling how much force is applied to each plate by combining high frequency data from three pressure sensors in each plate. The data is displayed in the app as a time series graph and can also be exported.</description>
      <arm_group_label>4-week control period + 4-week intervention period</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children with disabilities aged 3-17 years who uses a standing frame&#xD;
  &#xD;
            -  Informed consent from parents&#xD;
  &#xD;
            -  Informed consent from children aged 15-17 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Earlier interventions in the form of orthopedic surgery within the past 52 weeks&#xD;
  &#xD;
            -  Injections with botulinum toxin type A in the 12 weeks prior to baseline assessments&#xD;
  &#xD;
            -  Insufficient co-operation and cognitive understanding to participate in the study&#xD;
  &#xD;
            -  Planned interventions in form of orthopedic surgery and/or botulinum toxin type A in&#xD;
               the study period&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anders Holsgaard-Larsen, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Clinical Research, SDU &amp; Department of Orthopaedics and Traumatology, OUH</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lærke Krarup, MSc</last_name>
      <phone>+4526172592</phone>
      <email>lkrarup@health.sdu.dk</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Southern Denmark</name>
        <address>
          <city>Odense C</city>
          <zip>5000</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <investigator>
        <last_name>Lærke Krarup, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Children</keyword>
    <keyword>Adolescents</keyword>
    <keyword>Standing frame</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Due to ethical and legal considerations, our data cannot be shared publicly. This is due to the restrictions from the Regional and the National Committee on Health Research Ethics and the General Data Protection Regulation (EU) 2016/679, since the data contains person-specific information on birth date, sex, and diagnosis classification among other.&#xD;
  Data are available for researchers who meet the criteria for access to confidential data. Access may be acquired through contact to the research group.</ipd_description>
    </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/NCT06033885
  org study id: 11.928
  nct id: NCT06033885
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Standing frames have existed for a long time and are well-established medical devices used to
        allow weight bearing in standing for persons who are unable to stand independently.
  
        Documenting the effectiveness of interventions using standing frames is complex. The current
        evidence base for their use is limited due to studies of low to moderate quality and small
        effects documented.
  
        Providing real-time feed-back on force and position and thus continuous tracking of the
        intensity allows for informed decision making about the support provided by the standing
        frame in clinical settings, thereby making it possible to document the potential setup for
        optimal support and potential association between the intensity and positive effects of the
        standing frames.
  
        The objective of the study is to document potential short-term benefits on a) patient
        satisfaction and health-related quality of life and b) changes in prescription from the
        prescribing therapist of the use of standing frames in children with standing disabilities
        when PONDUS®, a digital product used to assess the force applied during standing in a R82
        standing frame is applied opposed to current practice.
  
        The study is a one-arm feasibility intervention study using participants as their own
        controls. The study will include 15 children with functional disabilities who currently uses
        a standing frame.
  Most children stand independently by the age of 11 month, allowing them to apply different
        loads on their bones, joints, and muscles, and experience their surroundings from a new
        perspective (1-2). Children who do not reach the motor milestone "standing" in early
        childhood should have access to assistive medical devices such as standing frames, which
        enable them to gain benefits of the standing position as typically developing children (3).
  
        Standing frames have existed for a long time and are well-established medical devices used to
        allow weight bearing in standing for persons who are unable to stand independently. The frame
        supports the child with upholstered plates and straps around the legs, trunk and/or head and
        is often positioned in an almost vertical posture, allowing the user partial weight bearing
        on their lower extremities. The devices are widely used as part of postural management for
        persons with disability (4-5) and a population-based study in Sweden shows that 31% of all
        children with cerebral palsy use external support to stand (6).
  
        Documenting the effectiveness of interventions using standing frames is complex. The current
        evidence base for their use is limited due to studies of low to moderate quality and small
        effects documented (5, 7, 8-17). A systematic review (5) and recent studies on the potential
        benefits of using standing frames indicate improvements in a range of functions and
        activities including: mental functions (7), bone and joint development and health (8-12),
        cardiovascular and respiratory systems, digestive systems and urinary functions (7-8),
        neuromusculoskeletal and movement related functions, pain (7-8), mobility (13), the ability
        to maintain a sitting or standing position (14-16), and major life areas, including
        interaction with peers (5, 17). Importantly, the studies did not report adverse events or
        serious harm.
  
        The above studies reveal a large variety in dosing in terms of frequency and time of use of
        the standing frames from <1 to 7 days per week, 1 or more sessions per day and <30 min to
        >120 min per session (5). Importantly, none of the studies document dosing in terms of
        intensity assessed as the degree of weight bearing while using a standing frame. Multiple
        variables such as type of frame, use of supports, inclination, activities performed while
        standing and inclination of the frame have been suggested to affect weight bearing in
        standing frames (18). Instrumented standing frames have been used in experimental settings
        and have documented a large variation in percentage of body weight from 23-133%, which could
        indicate serious issues of controlling the intensity or even misuse and/or measurement error
        (18-20). To our knowledge, instrumented standing frames that can assess force and position
        during the use of a standing frames is currently not available for use in clinical practice.
  
        The lack of information about force and position during the use of standing frames in
        clinical settings makes it impossible to document the potential setup for optimal support and
        potential association between the intensity and positive effects of the standing frames and,
        moreover, whether the intensity of the intervention should be tailored to the individual
        child.
  
        Providing real-time feed-back on force and position and thus continuous tracking of the
        intensity allows for informed decision making about the support provided by the standing
        frame in a clinical setting.
  
        The purpose of this study is to document potential short-term benefits on a) patient
        satisfaction and health-related quality of life and b) changes in prescription from the
        prescribing therapist of the use of standing frames in children with standing disabilities
        when PONDUS®, a digital product used to assess the force applied during standing in a R82
        standing frame, is applied opposed to current practice.
  
        The study is a one-arm feasibility intervention study using participants as their own
        controls. The study will be conducted in special day-care centers and schools or in the
        children's home. Participants will be 15 children with functional disabilities in the age of
        3-17 years who currently uses a standing frame.
  
        Recruitment will be conducted in collaboration with the study's commercial partner's
        distributor network and special day-care centers and schools across Denmark, that will assist
        in identifying possible study participants. In addition to the above parents will be reached
        through advocacy organizations or on social medias with an invitation for participation in
        the studies.
  
        Prior to the intervention a 4-week control period, where the non-instrumented standing frame
        is used according to standard practice, will be carried out. Subsequently, a 4-week
        intervention period, where the standing frame is instrumented (PONDUS®) allowing continued
        monitoring and adjustments of the force and position during sessions will be conducted.
        Changes in outcome measures will be evaluated as the difference in within-group change score
        between the control period and intervention period.
  
        Participation in the study will be voluntary and all participants will be informed that even
        after the eventual acceptance of participation, at any stage of the project they may decide
        to discontinue participation in the trial without giving any reason and without it having
        consequences for further treatment.
  
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         11. Macias-Merlo L, Bagur-Calafat C, Girabent-Farrés M, Stuberg WA. Standing Programs to
             Promote Hip Flexibility in Children With Spastic Diplegic Cerebral Palsy. Pediatr Phys
             Ther. 2015 Fall;27(3):243-9. doi: 10.1097/PEP.0000000000000150.
  
         12. Hough JP, Boyd RN, Keating JL. Systematic review of interventions for low bone mineral
             density in children with cerebral palsy. Pediatrics. 2010;125(3):e670-e678.
             Doi:10.1542/peds.2009-0292
  
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  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Patient satisfaction with an instrumented standing frame
  time frame: 8 weeks difference in change score between the control period and intervention period
  description: Patient satisfaction with an instrumented standing frame will be assessed with the Quebec User Evaluation of Satisfaction with Assistive Technology (Quest 2.0) questionnaires eight items assessing characteristics of the assistive device in terms of the following dimensions: 1) dimensions (size), 2. weight, 3. adjustments, 4. safety, 5. durability, 6. simplicity of use, 7. comfort and 8. effectiveness
  measure: The three most important aspects of patient satisfaction with an instrumented standing frame
  time frame: 8 weeks difference in change score between the control period and intervention period
  description: Through user involvement, the three key aspects of patient satisfaction with an instrumented standing frame will be selected from the Quebec User Evaluation of Satisfaction with Assistive Technology (Quest 2.0) questionnaire
  measure: Usability of an instrumented standing frame
  time frame: 8 weeks difference in change score between the control period and intervention period
  description: Usability of an instrumented standing frame will be assessed with the Usefulness, Satisfaction, and Ease of use (USE) Questionnaire
  measure: Health-related quality of life
  time frame: 8 weeks difference in change score between the control period and intervention period
  description: Health-related quality of life will be assessed with the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) questionnaire
  measure: Changes in prescription from the prescribing therapist
  time frame: 8 weeks difference in change score between the control period and intervention period
  description: Changes in prescription from the prescribing therapist of the use of the standing frame when PONDUS® is applied opposed to current practice will be assessed with a self-constructed questionnaire made for the purpose
  measure: Patient satisfaction with assistive device service of an instrumented standing frame
  time frame: 8 weeks difference in change score between the control period and intervention period
  description: Patient satisfaction with assistive device service of an instrumented standing frame will be assessed with the Quebec User Evaluation of Satisfaction with Assistive Technology (Quest 2.0) questionnaires four items assessing characteristics of service in terms of the following dimensions: 1. service delivery, 2. repairs and service of the device, 3. professionalism of service and 4. follow-up service
  measure: Patient satisfaction with PONDUS®
  time frame: 4 weeks score from the intervention period
  description: Patient satisfaction with PONDUS® will be assessed with the Quebec User Evaluation of Satisfaction with Assistive Technology (Quest 2.0) questionnaire
  arm group label: 4-week control period + 4-week intervention period
  arm group type: Experimental
  description: Prior to the intervention a 4-week control period, where the non-instrumented standing frame is used according to current practice, will be carried out. Subsequently, a 4-week intervention period, where the standing frame is instrumented (PONDUS®) allowing continued adjustments of the force and position within and between sessions will be conducted.
  intervention type: Device
  intervention name: PONDUS®
  description: PONDUS® is a CE-marked medical device to support the positioning of the user in a R82 standing frame.
  PONDUS® is designed as a pair of instrumented foot plates and an app as an external display.
  PONDUS® gives individual readings from the right and the left plate telling how much force is applied to each plate by combining high frequency data from three pressure sensors in each plate. The data is displayed in the app as a time series graph and can also be exported.
  arm group label: 4-week control period + 4-week intervention period
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Anders Holsgaard-Larsen, Professor
  role: Principal Investigator
  affiliation: Department of Clinical Research, SDU & Department of Orthopaedics and Traumatology, OUH
  last name: Lærke Krarup, MSc
  phone: +4526172592
  email: lkrarup@health.sdu.dk
  facility: 
  investigator: 
  country: Denmark
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: Due to ethical and legal considerations, our data cannot be shared publicly. This is due to the restrictions from the Regional and the National Committee on Health Research Ethics and the General Data Protection Regulation (EU) 2016/679, since the data contains person-specific information on birth date, sex, and diagnosis classification among other.
  Data are available for researchers who meet the criteria for access to confidential data. Access may be acquired through contact to the research group.