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/NCT05989113</url>
    </required_header>
    <id_info>
      <org_study_id>HOP23-RIPH3-09</org_study_id>
      <nct_id>NCT05989113</nct_id>
    </id_info>
    <brief_title>Psychometric Qualities IPAQ-SF</brief_title>
    <acronym>QUAPSY</acronym>
    <official_title>Evaluation of the Psychometric Qualities of the International Physical Activity Questionnaire-Short Form (IPAQ-SF) in Patients With Lower Limb Amputations (QUAPSY)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>FondationbHopale</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>FondationbHopale</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an observational, prospective multicentric study designed to develop medical&#xD;
        knowledge.&#xD;
  &#xD;
        The aim of the study is to validate the IPAQ-SF questionnaire in a population of lower limb&#xD;
        amputee patients.&#xD;
  &#xD;
        The questionnaire is administered twice to each patient, once during the consultation and&#xD;
        again when they return home. Patients also undergo a 6-minute walk test.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an observational, prospective multicentric study designed to develop medical&#xD;
        knowledge.&#xD;
  &#xD;
        The IPAQ is an internationally validated questionnaire for measuring physical activity in&#xD;
        healthy subjects.&#xD;
  &#xD;
        The IPAQ-SF (short format of the IPAQ) assesses overall physical activity and sedentary time&#xD;
        during the last seven days. The IPAQ-SF has been used in a population of lower limb amputees&#xD;
        on several occasions, but no study of its psychometric qualities in application to this&#xD;
        population has been performed to date.&#xD;
  &#xD;
        The main objective of the study is therefore to gather a set of arguments allowing the&#xD;
        IPAQ-SF to be used in the follow-up consultation of patients with lower limb amputations who&#xD;
        are fitted with a device.&#xD;
  &#xD;
        This would help health professionals to assess the physical activity of this population and&#xD;
        to develop physical activity promotion interventions adapted to their needs.&#xD;
  &#xD;
        This study is part of the standard management of patients with lower limb amputations and&#xD;
        devices. In addition to the clinical data and the result of the 6-minute test from the&#xD;
        classical management, the IPAQ-SF questionnaire will be completed twice by the patients&#xD;
        included in this study:&#xD;
  &#xD;
          -  Once during the consultation,&#xD;
  &#xD;
          -  Once at home.&#xD;
  &#xD;
        For the only center equipped (center 01) with inertial sensors, the gait parameters during&#xD;
        the 6-minute test will be collected in order to extract fatigue indices.&#xD;
  &#xD;
        Upon completion of the IPAQ-SF questionnaire a second time, the patient's participation in&#xD;
        the study ends.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 3, 2023</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Correlation of the METs/week questionnaire results with the results of the 6-minute walk test</measure>
      <time_frame>Data collection during the routine consultation on the day of inclusion</time_frame>
      <description>The results of the IPAQ-SF questionnaire will be expressed in METs/week (Metabolic Equivalent of Task).&#xD;
  The distance covered by the patient at the end of the 6-minute test will be collected in meters.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Relationships between the patients ability to perform his or her expected daily functions after rehabilitation (MFCL classification, out of 5 points) and the IPAQ-SF score.</measure>
      <time_frame>Data collection during the routine consultation on the day of inclusion</time_frame>
      <description>The MFCL consists of five ordered categories or 'K-levels' that define increasing functional mobility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationships between the level of amputation and the IPAQ-SF score.</measure>
      <time_frame>Data collection during the routine consultation on the day of inclusion</time_frame>
      <description>5 levels of amputation :&#xD;
  Hip disarticulation&#xD;
  Transfemoral amputation&#xD;
  Knee disarticulation&#xD;
  Transtibial amputation&#xD;
  Trans-iliolumbar amputation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationships between the patient's weight and the IPAQ-SF score.</measure>
      <time_frame>Data collection during the routine consultation on the day of inclusion</time_frame>
      <description>Patient's weight in kilogram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationships between type of prosthesis and the IPAQ-SF score.</measure>
      <time_frame>Data collection during the routine consultation on the day of inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationships between the age of amputation and the IPAQ-SF score.</measure>
      <time_frame>Data collection during the routine consultation on the day of inclusion</time_frame>
      <description>Age of amputation in years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationships between the physical activity level of lower limb amputee patients and the patient's walking speed measured by inertial units during the 6-minute test.</measure>
      <time_frame>Data collection during the 6-minute routine consultation test on the day of inclusion</time_frame>
      <description>The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters.&#xD;
  Patient's walking speed in meters per second during the 6-minute test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationship between the physical activity level of patients with lower-limb amputations and the patient's average step length measured by inertial units during the 6-minute test.</measure>
      <time_frame>Data collection during the 6-minute routine consultation test on the day of inclusion</time_frame>
      <description>The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters.&#xD;
  Patient's average step length in centimeters during the 6-minute test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationship between the physical activity level of patients with lower-limb amputations and the average width of the patient's step measured by inertial units during the 6-minute test.</measure>
      <time_frame>Data collection during the 6-minute routine consultation test on the day of inclusion</time_frame>
      <description>The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters.&#xD;
  Patient's average step width in centimeters during the 6-minute test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationship between the physical activity level of patients with lower-limb amputations and the patient's walking cadence measured by inertial units during the 6-minute test.</measure>
      <time_frame>Data collection during the 6-minute routine consultation test on the day of inclusion</time_frame>
      <description>The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters.&#xD;
  Number of steps per minute during the 6-minute test.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Amputation</condition>
    <condition>Lower Extremity Amputation</condition>
    <condition>Gait Analysis</condition>
    <condition>Questionnaires</condition>
    <arm_group>
      <arm_group_label>Lower limb amputee patients with devices</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Administration of the IPAQ-SF questionnaire</intervention_name>
      <description>Administration of the IPAQ-SF questionnaire at the patient's consultation and upon return home</description>
      <arm_group_label>Lower limb amputee patients with devices</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Lower limb amputee patients with devices&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who have undergone a major lower limb amputation: transtibial, transfemoral,&#xD;
               hip or knee disarticulation or trans-iliolumbar&#xD;
  &#xD;
            -  Fitting more than 1 year old&#xD;
  &#xD;
            -  Age 15-69 years (IPAQ-SF not validated outside these ages)&#xD;
  &#xD;
            -  All causes of amputation (vascular, traumatic, tumor, infectious...)&#xD;
  &#xD;
            -  Patient having given their informed consent&#xD;
  &#xD;
            -  Patient affiliated to a social security system&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects with bilateral amputations&#xD;
  &#xD;
            -  Inability to fully and adequately understand the questionnaire (i.e., cognitive&#xD;
               impairment, patient does not speak French)&#xD;
  &#xD;
            -  Contraindication to the 6-minute walk test (chest pain, palpitations, mental confusion&#xD;
               or lack of coordination and balance, dizziness or malaise, intolerable dyspnea, leg&#xD;
               cramps or extreme leg muscle fatigue, any other clinically justified reason).&#xD;
  &#xD;
            -  Patients under legal protection (under guardianship, under curatorship, safeguard of&#xD;
               justice)&#xD;
  &#xD;
            -  Pregnant or breast-feeding woman&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>69 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Frédéric Charlaté</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fondation Hopale</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marine Deseur</last_name>
      <phone>0362882780</phone>
      <email>marine.deseur@fondation-hopale.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elias Ghehioueche</last_name>
      <email>elias.ghehioueche@chu-lille.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Institut Calvé</name>
        <address>
          <city>Berck</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marine Deseur</last_name>
        <phone>03 62 88 27 80</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHRU Lille - Hôpital Swynghedauw</name>
        <address>
          <city>Lille</city>
          <zip>59037</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elias GHEHIOUECHE</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CRF les HAUTOIS- CRO</name>
        <address>
          <city>Oignies</city>
          <zip>62590</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elias GHEHIOUECHE</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <link>
      <url>https://doi.org/10.1177/0309364612437905</url>
      <description>Deans S, Burns D, McGarry A, et al. Motivations and barriers to prosthesis users participation in physical activity, exercise and sport: a review of the literature. Prosthet Orthot Int. 2012;36:260-269.</description>
    </link>
    <link>
      <url>https://doi.org/10.3390/s140405845</url>
      <description>Hordacre, B., Barr, C., &amp; Crotty, M. (2014). Use of an activity monitor and GPS device to assess community activity and participation in transtibial amputees. Sensors (Basel, Switzerland), 14(4), 5845-5859</description>
    </link>
    <link>
      <url>https://doi.org/10.1097/00002060-200203000-00007</url>
      <description>Wetterhahn, K. A., Hanson, C., &amp; Levy, C. E. (2002). Effect of participation in physical activity on body image of amputees. American journal of physical medicine &amp; rehabilitation, 81(3), 194-201.</description>
    </link>
    <link>
      <url>https://doi.org/10.1590/1806-9282.20210382</url>
      <description>Melo, V. H., Sousa, R. A. L., Improta-Caria, A. C., &amp; Nunes, M. A. P. (2021). Physical activity and quality of life in adults and elderly individuals with lower limb amputation. Revista da Associacao Medica Brasileira (1992), 67(7), 985-990</description>
    </link>
    <link>
      <url>https://doi.org/10.1177/0309364611425093</url>
      <description>da Silva, R., Rizzo, J. G., Gutierres Filho, P. J., Ramos, V., &amp; Deans, S. (2011). Physical activity and quality of life of amputees in southern Brazil. Prosthetics and orthotics international, 35(4), 432-438.</description>
    </link>
    <link>
      <url>https://doi.org/10.1093/gerona/glx254</url>
      <description>Del Din, S., Galna, B., Godfrey, A., Bekkers, E. M. J., Pelosin, E., Nieuwhof, F., Mirelman, A., Hausdorff, J. M., &amp; Rochester, L. (2019). Analysis of Free-Living Gait in Older Adults With and Without Parkinson's Disease and With and Without a History of</description>
    </link>
    <link>
      <url>https://doi.org/10.1007/s00415-019-09500-z</url>
      <description>Shema-Shiratzky (2019). Deterioration of specific aspects of gait during the instrumented 6-min walk test among people with multiple sclerosis. Jou</description>
    </link>
    <link>
      <url>https://doi.org/10.1371/journal.pone.0158623</url>
      <description>Van Schooten (2016). Daily-Life Gait Quality as Predictor of Falls in Older People: A 1-Year Prospective Cohort Study.</description>
    </link>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>April 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT05989113
  org study id: HOP23-RIPH3-09
  nct id: NCT05989113
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an observational, prospective multicentric study designed to develop medical
        knowledge.
  
        The aim of the study is to validate the IPAQ-SF questionnaire in a population of lower limb
        amputee patients.
  
        The questionnaire is administered twice to each patient, once during the consultation and
        again when they return home. Patients also undergo a 6-minute walk test.
  This is an observational, prospective multicentric study designed to develop medical
        knowledge.
  
        The IPAQ is an internationally validated questionnaire for measuring physical activity in
        healthy subjects.
  
        The IPAQ-SF (short format of the IPAQ) assesses overall physical activity and sedentary time
        during the last seven days. The IPAQ-SF has been used in a population of lower limb amputees
        on several occasions, but no study of its psychometric qualities in application to this
        population has been performed to date.
  
        The main objective of the study is therefore to gather a set of arguments allowing the
        IPAQ-SF to be used in the follow-up consultation of patients with lower limb amputations who
        are fitted with a device.
  
        This would help health professionals to assess the physical activity of this population and
        to develop physical activity promotion interventions adapted to their needs.
  
        This study is part of the standard management of patients with lower limb amputations and
        devices. In addition to the clinical data and the result of the 6-minute test from the
        classical management, the IPAQ-SF questionnaire will be completed twice by the patients
        included in this study:
  
          -  Once during the consultation,
  
          -  Once at home.
  
        For the only center equipped (center 01) with inertial sensors, the gait parameters during
        the 6-minute test will be collected in order to extract fatigue indices.
  
        Upon completion of the IPAQ-SF questionnaire a second time, the patient's participation in
        the study ends.
  observational model: Case-Only
  time perspective: Prospective
  measure: Correlation of the METs/week questionnaire results with the results of the 6-minute walk test
  time frame: Data collection during the routine consultation on the day of inclusion
  description: The results of the IPAQ-SF questionnaire will be expressed in METs/week (Metabolic Equivalent of Task).
  The distance covered by the patient at the end of the 6-minute test will be collected in meters.
  measure: Relationships between the patients ability to perform his or her expected daily functions after rehabilitation (MFCL classification, out of 5 points) and the IPAQ-SF score.
  time frame: Data collection during the routine consultation on the day of inclusion
  description: The MFCL consists of five ordered categories or 'K-levels' that define increasing functional mobility.
  measure: Relationships between the level of amputation and the IPAQ-SF score.
  time frame: Data collection during the routine consultation on the day of inclusion
  description: 5 levels of amputation :
  Hip disarticulation
  Transfemoral amputation
  Knee disarticulation
  Transtibial amputation
  Trans-iliolumbar amputation
  measure: Relationships between the patient's weight and the IPAQ-SF score.
  time frame: Data collection during the routine consultation on the day of inclusion
  description: Patient's weight in kilogram
  measure: Relationships between type of prosthesis and the IPAQ-SF score.
  time frame: Data collection during the routine consultation on the day of inclusion
  measure: Relationships between the age of amputation and the IPAQ-SF score.
  time frame: Data collection during the routine consultation on the day of inclusion
  description: Age of amputation in years
  measure: Relationships between the physical activity level of lower limb amputee patients and the patient's walking speed measured by inertial units during the 6-minute test.
  time frame: Data collection during the 6-minute routine consultation test on the day of inclusion
  description: The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters.
  Patient's walking speed in meters per second during the 6-minute test.
  measure: Relationship between the physical activity level of patients with lower-limb amputations and the patient's average step length measured by inertial units during the 6-minute test.
  time frame: Data collection during the 6-minute routine consultation test on the day of inclusion
  description: The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters.
  Patient's average step length in centimeters during the 6-minute test.
  measure: Relationship between the physical activity level of patients with lower-limb amputations and the average width of the patient's step measured by inertial units during the 6-minute test.
  time frame: Data collection during the 6-minute routine consultation test on the day of inclusion
  description: The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters.
  Patient's average step width in centimeters during the 6-minute test.
  measure: Relationship between the physical activity level of patients with lower-limb amputations and the patient's walking cadence measured by inertial units during the 6-minute test.
  time frame: Data collection during the 6-minute routine consultation test on the day of inclusion
  description: The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters.
  Number of steps per minute during the 6-minute test.
  arm group label: Lower limb amputee patients with devices
  intervention type: Other
  intervention name: Administration of the IPAQ-SF questionnaire
  description: Administration of the IPAQ-SF questionnaire at the patient's consultation and upon return home
  arm group label: Lower limb amputee patients with devices
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 69 Years
  last name: Frédéric Charlaté
  role: Principal Investigator
  affiliation: Fondation Hopale
  last name: Marine Deseur
  phone: 0362882780
  email: marine.deseur@fondation-hopale.org
  last name: Elias Ghehioueche
  email: elias.ghehioueche@chu-lille.fr
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: France
  url: https://doi.org/10.1177/0309364612437905
  description: Deans S, Burns D, McGarry A, et al. Motivations and barriers to prosthesis users participation in physical activity, exercise and sport: a review of the literature. Prosthet Orthot Int. 2012;36:260-269.
  url: https://doi.org/10.3390/s140405845
  description: Hordacre, B., Barr, C., & Crotty, M. (2014). Use of an activity monitor and GPS device to assess community activity and participation in transtibial amputees. Sensors (Basel, Switzerland), 14(4), 5845-5859
  url: https://doi.org/10.1097/00002060-200203000-00007
  description: Wetterhahn, K. A., Hanson, C., & Levy, C. E. (2002). Effect of participation in physical activity on body image of amputees. American journal of physical medicine & rehabilitation, 81(3), 194-201.
  url: https://doi.org/10.1590/1806-9282.20210382
  description: Melo, V. H., Sousa, R. A. L., Improta-Caria, A. C., & Nunes, M. A. P. (2021). Physical activity and quality of life in adults and elderly individuals with lower limb amputation. Revista da Associacao Medica Brasileira (1992), 67(7), 985-990
  url: https://doi.org/10.1177/0309364611425093
  description: da Silva, R., Rizzo, J. G., Gutierres Filho, P. J., Ramos, V., & Deans, S. (2011). Physical activity and quality of life of amputees in southern Brazil. Prosthetics and orthotics international, 35(4), 432-438.
  url: https://doi.org/10.1093/gerona/glx254
  description: Del Din, S., Galna, B., Godfrey, A., Bekkers, E. M. J., Pelosin, E., Nieuwhof, F., Mirelman, A., Hausdorff, J. M., & Rochester, L. (2019). Analysis of Free-Living Gait in Older Adults With and Without Parkinson's Disease and With and Without a History of
  url: https://doi.org/10.1007/s00415-019-09500-z
  description: Shema-Shiratzky (2019). Deterioration of specific aspects of gait during the instrumented 6-min walk test among people with multiple sclerosis. Jou
  url: https://doi.org/10.1371/journal.pone.0158623
  description: Van Schooten (2016). Daily-Life Gait Quality as Predictor of Falls in Older People: A 1-Year Prospective Cohort Study.
  responsible party type: Sponsor