<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/NCT03828331</url>
  </required_header>
  <id_info>
    <org_study_id>A3010-P</org_study_id>
    <nct_id>NCT03828331</nct_id>
  </id_info>
  <brief_title>Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations</brief_title>
  <acronym>BestBikeFit</acronym>
  <official_title>Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bicycling is a promising form of low-impact exercise that could prevent/treat Type 2&#xD;
      diabetes. However, Veterans with transtibial amputations (TTAs) may not effectively utilize&#xD;
      bicycling for rehabilitation and exercise due to improper bike fit, socket discomfort, and/or&#xD;
      the potential for injury. An optimized prosthetic/bicycle fit could improve comfort and&#xD;
      reduce injury risk by decreasing asymmetries between legs, lowering metabolic costs, and&#xD;
      improving efficiency for Veterans with TTAs during bicycling. Moreover, the use of objective&#xD;
      prosthetic/bicycle fit guidelines would allow clinicians to facilitate shorter appointment&#xD;
      times and fewer revisits for Veterans with TTAs. The investigators will determine the&#xD;
      physiological and biomechanical effects of different prosthetic and bicycle configurations&#xD;
      for Veterans with a TTA to develop optimal prosthetic/bicycle fit guidelines. The&#xD;
      investigators hypothesize that a longer prosthetic pylon length and shorter bicycle crank arm&#xD;
      length for the affected compared to the unaffected leg along with a pedal attachment position&#xD;
      beneath the pylon compared to beneath the forefoot will optimize performance for Veterans&#xD;
      with TTAs the investigators' research will integrate evidence-based guidelines to advance&#xD;
      rehabilitation and enhance the lives of Veterans with an amputation, thus improving and&#xD;
      restoring their function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over one million people in the United States have a leg amputation and this number continues&#xD;
      to grow due to the prevalence of diabetes and recent military conflicts. Because of the&#xD;
      functional impairment caused by an amputation, it is extremely important to advance&#xD;
      rehabilitation that optimizes the use of prostheses so that Veterans with amputations can&#xD;
      regain the greatest possible level of health, function, and physical activity. Low-impact&#xD;
      exercise such as bicycling could facilitate return to work/duty after amputation by improving&#xD;
      cardiovascular fitness, muscle strength, endurance, and quality of life for Veterans with&#xD;
      transtibial amputations (TTAs). Bicycling as exercise could also prevent the deleterious&#xD;
      effects of vascular disease and diabetes by improving cardiovascular function, controlling&#xD;
      body weight, decreasing the rate of re-amputation, and improving quality of life for Veterans&#xD;
      with TTAs. However, it is likely that discomfort and the increased potential for secondary&#xD;
      musculoskeletal injury due to the lack of a proper prosthetic/bike fit discourages Veterans&#xD;
      with TTAs from using bicycling for rehabilitation and exercise. Moreover, it is unclear how&#xD;
      prosthetic and bicycle components, such as pylon length (PL), pedal attachment position (PAP)&#xD;
      beneath the prosthetic forefoot versus the pylon, and crank arm length (CAL) affect the&#xD;
      biomechanics, metabolic costs, and comfort/ satisfaction of Veterans with TTAs. Thus, the&#xD;
      investigators' goal is to challenge the state-of-the-science by developing evidence-based&#xD;
      prosthetic and bicycle fit guidelines that optimize the biomechanics, metabolic costs,&#xD;
      efficiency (mechanical power/metabolic power) and comfort/satisfaction for Veterans with&#xD;
      TTAs. The Department of Veterans Affairs (VA) and Department of Defense (DoD) Rehabilitation&#xD;
      Directive has put forth an initiative that aims to dramatically improve and restore function&#xD;
      in wounded Veterans and Service members so that they have the choice to return to active duty&#xD;
      or productive civilian employment. The proposed research will establish optimal&#xD;
      prosthetic/bicycle fit guidelines, which would enhance function by improving cardiovascular&#xD;
      health, controlling body weight, decreasing re-amputation rates, and enhancing quality of&#xD;
      life of Veterans with TTAs, thus helping to fulfill this initiative and having high potential&#xD;
      impact. Specifically, the investigators aim to: 1) Study 15 Veterans with unilateral TTAs to&#xD;
      determine the effects of systematically varying PL, PAP beneath the prosthetic forefoot&#xD;
      versus the pylon, and CAL for the affected leg on bicycling biomechanics, metabolic costs,&#xD;
      and comfort/satisfaction. 2) Synthesize and disseminate the investigators' findings into&#xD;
      practical, evidence-based quantitative prosthetic/bicycle fit guidelines for Veterans with&#xD;
      TTAs. The investigators hypothesize that a longer PL and shorter CAL for the affected&#xD;
      compared to the unaffected leg along with a PAP beneath the pylon compared to beneath the&#xD;
      forefoot will maximize mechanical power symmetry and reduce metabolic cost and muscle&#xD;
      activity, and thus maximize efficiency and comfort/satisfaction during bicycling in Veterans&#xD;
      with unilateral TTAs. The utilization of evidence-based prosthetic/bicycle fit guidelines&#xD;
      that increase symmetry, improve comfort, reduce the risk of injury, decrease metabolic costs,&#xD;
      and improve efficiency will directly benefit Veterans with TTAs by increasing their physical&#xD;
      activity and function. Optimized prosthetic/bicycle fit guidelines will allow Veterans TTAs&#xD;
      who were previously unable to comfortably ride a bicycle, as well as those currently riding a&#xD;
      bicycle, to ride longer with less effort and discomfort, potentially leading to an improved&#xD;
      quality of life. Moreover, the prosthetic/bicycle fit guidelines generated by this research&#xD;
      will ensure that clinicians are able to fit Veterans with TTAs to bicycles more effectively,&#xD;
      leading to shorter appointment times and fewer revisits due to enhanced function and reduced&#xD;
      comorbidities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">August 31, 2023</completion_date>
  <primary_completion_date type="Actual">August 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Motion will be measured using 3D motion capture</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The investigators will measure motion (rad) while participants bicycle using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of oxygen consumption and carbon dioxide production will be measured using indirect calorimetry to calculate metabolic power</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The investigators will measure and compare metabolic power from while participants bicycle using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>comfort/pain will be measured with a Visual Analog Scale (VAS)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The investigators will measure and compare comfort/pain with a questionnaire that has a range of 0-10 that indicates no pain to the worst pain, respectively, after participants bicycle using each different prosthetic and bicycle configuration (pylon length, crank arm length, and pedal attachment position).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forces will be measured using force-measuring pedals</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The investigators will simultaneously measure forces (N) while participants bicycle using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Activity will be measured using electromyography</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The investigators will measure muscle activity (v) while participants bicycle using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>comfort/satisfaction will be measured with a modified Prosthesis Evaluation Questionnaire (PEQ)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The investigators will measure and compare comfort/satisfaction with a questionnaire that has a series of questions that have a range of 0-10 that indicates worst to best, respectively, after participants bicycle using each different prosthetic and bicycle configuration (pylon length, crank arm length, and pedal attachment position).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Amputation</condition>
  <arm_group>
    <arm_group_label>Participants with Transtibial Amputation</arm_group_label>
    <description>The investigators will recruit participants with unilateral transtibial amputations who are at or above a K3 Medicare functional classification level (MFCL), and 18-55 years old. A K3 MFCL means that a person has the ability or potential for ambulation with variable cadence. A person at K3 MFCL is a typical community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic or exercise activity that demands prosthetic use beyond simple locomotion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prosthetic/Bicycle Configuration</intervention_name>
    <description>The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects ride using an initial bike fit and three taller pylon lengths (PL) for the affected leg (AL) in increments of 6.8 mm using a pedal attachment position (PAP) beneath the prosthetic forefoot. Then, using the optimal (most efficient) PL, the investigators will measure the biomechanics and metabolic rates while subjects ride using three shorter crank arm lengths (CALs) for the AL in decrements of 6.8 mm using a PAP beneath the prosthetic forefoot. On Day 2, the investigators will repeat the protocol of Day 1, but have riders use a PAP beneath the pylon for their AL.</description>
    <arm_group_label>Participants with Transtibial Amputation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators will recruit 15 subjects with unilateral transtibial amputations from the&#xD;
        VA Jewell Clinic, locally, and nationally.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One amputation below the knee&#xD;
&#xD;
          -  At least 1 year of experience using a prosthesis&#xD;
&#xD;
          -  No current problems with the prosthesis or residual limb&#xD;
&#xD;
          -  At or above a K3 Medicare Functional Classification Level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor general health&#xD;
&#xD;
          -  Difficulty with mobility&#xD;
&#xD;
          -  Problems with balance or dizziness&#xD;
&#xD;
          -  Current serious musculoskeletal injury besides that associated with an amputation&#xD;
&#xD;
          -  Cardiovascular, pulmonary, or neurological disease or disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alena Grabowski, PhD BA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rocky Mountain Regional VA Medical Center, Aurora, CO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rocky Mountain Regional VA Medical Center, Aurora, CO</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03828331/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03828331
org study id: A3010-P
nct id: NCT03828331
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Bicycling is a promising form of low-impact exercise that could prevent/treat Type 2
      diabetes. However, Veterans with transtibial amputations (TTAs) may not effectively utilize
      bicycling for rehabilitation and exercise due to improper bike fit, socket discomfort, and/or
      the potential for injury. An optimized prosthetic/bicycle fit could improve comfort and
      reduce injury risk by decreasing asymmetries between legs, lowering metabolic costs, and
      improving efficiency for Veterans with TTAs during bicycling. Moreover, the use of objective
      prosthetic/bicycle fit guidelines would allow clinicians to facilitate shorter appointment
      times and fewer revisits for Veterans with TTAs. The investigators will determine the
      physiological and biomechanical effects of different prosthetic and bicycle configurations
      for Veterans with a TTA to develop optimal prosthetic/bicycle fit guidelines. The
      investigators hypothesize that a longer prosthetic pylon length and shorter bicycle crank arm
      length for the affected compared to the unaffected leg along with a pedal attachment position
      beneath the pylon compared to beneath the forefoot will optimize performance for Veterans
      with TTAs the investigators' research will integrate evidence-based guidelines to advance
      rehabilitation and enhance the lives of Veterans with an amputation, thus improving and
      restoring their function.
Over one million people in the United States have a leg amputation and this number continues
      to grow due to the prevalence of diabetes and recent military conflicts. Because of the
      functional impairment caused by an amputation, it is extremely important to advance
      rehabilitation that optimizes the use of prostheses so that Veterans with amputations can
      regain the greatest possible level of health, function, and physical activity. Low-impact
      exercise such as bicycling could facilitate return to work/duty after amputation by improving
      cardiovascular fitness, muscle strength, endurance, and quality of life for Veterans with
      transtibial amputations (TTAs). Bicycling as exercise could also prevent the deleterious
      effects of vascular disease and diabetes by improving cardiovascular function, controlling
      body weight, decreasing the rate of re-amputation, and improving quality of life for Veterans
      with TTAs. However, it is likely that discomfort and the increased potential for secondary
      musculoskeletal injury due to the lack of a proper prosthetic/bike fit discourages Veterans
      with TTAs from using bicycling for rehabilitation and exercise. Moreover, it is unclear how
      prosthetic and bicycle components, such as pylon length (PL), pedal attachment position (PAP)
      beneath the prosthetic forefoot versus the pylon, and crank arm length (CAL) affect the
      biomechanics, metabolic costs, and comfort/ satisfaction of Veterans with TTAs. Thus, the
      investigators' goal is to challenge the state-of-the-science by developing evidence-based
      prosthetic and bicycle fit guidelines that optimize the biomechanics, metabolic costs,
      efficiency (mechanical power/metabolic power) and comfort/satisfaction for Veterans with
      TTAs. The Department of Veterans Affairs (VA) and Department of Defense (DoD) Rehabilitation
      Directive has put forth an initiative that aims to dramatically improve and restore function
      in wounded Veterans and Service members so that they have the choice to return to active duty
      or productive civilian employment. The proposed research will establish optimal
      prosthetic/bicycle fit guidelines, which would enhance function by improving cardiovascular
      health, controlling body weight, decreasing re-amputation rates, and enhancing quality of
      life of Veterans with TTAs, thus helping to fulfill this initiative and having high potential
      impact. Specifically, the investigators aim to: 1) Study 15 Veterans with unilateral TTAs to
      determine the effects of systematically varying PL, PAP beneath the prosthetic forefoot
      versus the pylon, and CAL for the affected leg on bicycling biomechanics, metabolic costs,
      and comfort/satisfaction. 2) Synthesize and disseminate the investigators' findings into
      practical, evidence-based quantitative prosthetic/bicycle fit guidelines for Veterans with
      TTAs. The investigators hypothesize that a longer PL and shorter CAL for the affected
      compared to the unaffected leg along with a PAP beneath the pylon compared to beneath the
      forefoot will maximize mechanical power symmetry and reduce metabolic cost and muscle
      activity, and thus maximize efficiency and comfort/satisfaction during bicycling in Veterans
      with unilateral TTAs. The utilization of evidence-based prosthetic/bicycle fit guidelines
      that increase symmetry, improve comfort, reduce the risk of injury, decrease metabolic costs,
      and improve efficiency will directly benefit Veterans with TTAs by increasing their physical
      activity and function. Optimized prosthetic/bicycle fit guidelines will allow Veterans TTAs
      who were previously unable to comfortably ride a bicycle, as well as those currently riding a
      bicycle, to ride longer with less effort and discomfort, potentially leading to an improved
      quality of life. Moreover, the prosthetic/bicycle fit guidelines generated by this research
      will ensure that clinicians are able to fit Veterans with TTAs to bicycles more effectively,
      leading to shorter appointment times and fewer revisits due to enhanced function and reduced
      comorbidities.
observational model: Cohort
time perspective: Cross-Sectional
measure: Motion will be measured using 3D motion capture
time frame: Through study completion, an average of 1 year
description: The investigators will measure motion (rad) while participants bicycle using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
measure: Rates of oxygen consumption and carbon dioxide production will be measured using indirect calorimetry to calculate metabolic power
time frame: Through study completion, an average of 1 year
description: The investigators will measure and compare metabolic power from while participants bicycle using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
measure: comfort/pain will be measured with a Visual Analog Scale (VAS)
time frame: Through study completion, an average of 1 year
description: The investigators will measure and compare comfort/pain with a questionnaire that has a range of 0-10 that indicates no pain to the worst pain, respectively, after participants bicycle using each different prosthetic and bicycle configuration (pylon length, crank arm length, and pedal attachment position).
measure: Forces will be measured using force-measuring pedals
time frame: Through study completion, an average of 1 year
description: The investigators will simultaneously measure forces (N) while participants bicycle using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
measure: Muscle Activity will be measured using electromyography
time frame: Through study completion, an average of 1 year
description: The investigators will measure muscle activity (v) while participants bicycle using different prosthetic and bicycle configurations (pylon length, crank arm length, and pedal attachment position).
measure: comfort/satisfaction will be measured with a modified Prosthesis Evaluation Questionnaire (PEQ)
time frame: Through study completion, an average of 1 year
description: The investigators will measure and compare comfort/satisfaction with a questionnaire that has a series of questions that have a range of 0-10 that indicates worst to best, respectively, after participants bicycle using each different prosthetic and bicycle configuration (pylon length, crank arm length, and pedal attachment position).
arm group label: Participants with Transtibial Amputation
description: The investigators will recruit participants with unilateral transtibial amputations who are at or above a K3 Medicare functional classification level (MFCL), and 18-55 years old. A K3 MFCL means that a person has the ability or potential for ambulation with variable cadence. A person at K3 MFCL is a typical community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic or exercise activity that demands prosthetic use beyond simple locomotion.
intervention type: Other
intervention name: Prosthetic/Bicycle Configuration
description: The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects ride using an initial bike fit and three taller pylon lengths (PL) for the affected leg (AL) in increments of 6.8 mm using a pedal attachment position (PAP) beneath the prosthetic forefoot. Then, using the optimal (most efficient) PL, the investigators will measure the biomechanics and metabolic rates while subjects ride using three shorter crank arm lengths (CALs) for the AL in decrements of 6.8 mm using a PAP beneath the prosthetic forefoot. On Day 2, the investigators will repeat the protocol of Day 1, but have riders use a PAP beneath the pylon for their AL.
arm group label: Participants with Transtibial Amputation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alena Grabowski, PhD BA
role: Principal Investigator
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 