<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/NCT03249883</url>
  </required_header>
  <id_info>
    <org_study_id>0027-14-LOE</org_study_id>
    <nct_id>NCT03249883</nct_id>
  </id_info>
  <brief_title>Comparison of Prosthetic Feet for the Geriatric Patients(CPF)</brief_title>
  <acronym>CPF</acronym>
  <official_title>Evaluation of a Geriatric Foot- 1M10 ADJUST Versus the Solid Ankle Cushioned Heel Foot for Low Activity Amputees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loewenstein Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tel Aviv University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Loewenstein Hospital</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>
      The purpose of this study is to determine whether the geriatric prosthetic foot 1M10 is&#xD;
      superior to the classical SACH (Solid Ankle Cushion Heel) foot, when used by indoor&#xD;
      ambulators with a transtibial amputation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fourteen limited ambulators , unilateral trans tibial amputees, will be recruited in the&#xD;
      orthopedic rehabilitation department in our institute. Participants will be assigned randomly&#xD;
      to be fitted with a SACH or a 1M10 Otto Bock foot in their prosthesis.&#xD;
&#xD;
      Both types of feet will be &quot;dressed&quot; to look similarly. All participants will receive the&#xD;
      same rehabilitation protocol. After three weeks all participants will be tested functionally&#xD;
      in the &quot;10 meter walk test&quot; , and a &quot;Get up and go test&quot;. The participants will answer a&#xD;
      satisfaction questionnaire that is based on the &quot;Prosthesis Evaluation Questionnaire&quot; and&#xD;
      modified according to the aims of this trial.&#xD;
&#xD;
      Pressure patterns and gait parameters will be recorded using a pressure mat. At this time the&#xD;
      foot will be switched to the other study prosthetic foot, and the rehabilitation will&#xD;
      commence.&#xD;
&#xD;
      At the end of three weeks wearing the new foot the same set of tests will be run again.&#xD;
&#xD;
      The investigators aim to present the difference in satisfaction and in the functional&#xD;
      performance of the same participant wearing the two feet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2018</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prosthetic satisfaction Questionnaire</measure>
    <time_frame>Measured after 3 weeks</time_frame>
    <description>Hebrew satisfaction questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>10 meter walk test</measure>
    <time_frame>Measured after 3 weeks</time_frame>
    <description>The participants will be asked to walk at their comfort pace 10 meters. The time of completing the task will be recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Get up and go test</measure>
    <time_frame>Measured after 3 weeks</time_frame>
    <description>The participants will be asked to get up from a chair walk 3 meters turn around walk back to the chair and sit down. The time of completing the task will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prosthetic Satisfaction Questionnaire</measure>
    <time_frame>Measured after 6 weeks</time_frame>
    <description>Hebrew satisfaction questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>10 meter walk test</measure>
    <time_frame>Measured after 6 weeks</time_frame>
    <description>The participants will be asked to walk at their comfort pace 10 meters. The time of completing the task will be recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Get up and go test</measure>
    <time_frame>Measured after 6 weeks</time_frame>
    <description>The participants will be asked to get up from a chair walk 3 meters turn around walk back to the chair and sit down. The time of completing the task will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gait patterns</measure>
    <time_frame>Measured after 3 weeks and</time_frame>
    <description>Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait patterns</measure>
    <time_frame>Measured after 6 weeks</time_frame>
    <description>Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Amputation</condition>
  <arm_group>
    <arm_group_label>SACH first</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will use a SACH foot for the first three weeks of prosthetic gait training , and a 1M10 foot for the second three weeks of prosthetic gait training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1M10 first</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will use a 1M10 foot for the first three weeks of prosthetic gait training , and a SACH foot for the second three weeks of prosthetic gait training</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SACH prosthetic foot, 1M10 prosthetic foot</intervention_name>
    <description>In the SACH first group - the amputees will wear the SACH feet for three weeks and then switch to 1M10 feet for another three weeks.&#xD;
In the 1M10 first group - the amputees will wear the 1M10 feet for three weeks and then switch to SACH feet for another three weeks.</description>
    <arm_group_label>1M10 first</arm_group_label>
    <arm_group_label>SACH first</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral transtibial amputees&#xD;
&#xD;
          -  limited ambulators&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  do not speak Hebrew&#xD;
&#xD;
          -  are not cognitively intact&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hagay Amir, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director of Orthopedic rehabilitation Department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hagay Amir, MD</last_name>
    <phone>972-50-6263379</phone>
    <email>hagayam@clalit.org.il</email>
  </overall_contact>
  <results_reference>
    <citation>Chitragari G, Mahler DB, Sumpio BJ, Blume PA, Sumpio BE. Prosthetic options available for the diabetic lower limb amputee. Clin Podiatr Med Surg. 2014 Jan;31(1):173-85. doi: 10.1016/j.cpm.2013.09.008.</citation>
    <PMID>24296024</PMID>
  </results_reference>
  <results_reference>
    <citation>Agrawal V, Gailey RS, Gaunaurd IA, O'Toole C, Finnieston A, Tolchin R. Comparison of four different categories of prosthetic feet during ramp ambulation in unilateral transtibial amputees. Prosthet Orthot Int. 2015 Oct;39(5):380-9. doi: 10.1177/0309364614536762. Epub 2014 Jun 12.</citation>
    <PMID>24925671</PMID>
  </results_reference>
  <results_reference>
    <citation>Bonnet X, Adde JN, Blanchard F, Gedouin-Toquet A, Eveno D. Evaluation of a new geriatric foot versus the Solid Ankle Cushion Heel foot for low-activity amputees. Prosthet Orthot Int. 2015 Apr;39(2):112-8. doi: 10.1177/0309364613515492. Epub 2014 Jan 13.</citation>
    <PMID>24418934</PMID>
  </results_reference>
  <results_reference>
    <citation>Graham LA, Fyfe NC. Prosthetic rehabilitation of amputees aged over 90 is usually successful. Disabil Rehabil. 2002 Sep 10;24(13):700-1. doi: 10.1080/09638280210142194.</citation>
    <PMID>12296985</PMID>
  </results_reference>
  <results_reference>
    <citation>Vickers DR, Palk C, McIntosh AS, Beatty KT. Elderly unilateral transtibial amputee gait on an inclined walkway: a biomechanical analysis. Gait Posture. 2008 Apr;27(3):518-29. doi: 10.1016/j.gaitpost.2007.06.008. Epub 2007 Aug 17.</citation>
    <PMID>17707643</PMID>
  </results_reference>
  <results_reference>
    <citation>Edelstein JE. Prosthetic feet. State of the Art. Phys Ther. 1988 Dec;68(12):1874-81. doi: 10.1093/ptj/68.12.1874.</citation>
    <PMID>3057523</PMID>
  </results_reference>
  <results_reference>
    <citation>Hansen A, Sam M, Childress D. The effective foot length ratio: a potential tool for characterization and eval¬uation of prosthetic feet. J Prosthet Orthot 2004; 16(2): 41-45.</citation>
  </results_reference>
  <results_reference>
    <citation>Hansen AH, Meier MR, Sessoms PH, Childress DS. The effects of prosthetic foot roll-over shape arc length on the gait of trans-tibial prosthesis users. Prosthet Orthot Int. 2006 Dec;30(3):286-99. doi: 10.1080/03093640600816982.</citation>
    <PMID>17162519</PMID>
  </results_reference>
  <results_reference>
    <citation>Arifin N, Abu Osman NA, Ali S, Wan Abas WA. The effects of prosthetic foot type and visual alteration on postural steadiness in below-knee amputees. Biomed Eng Online. 2014 Mar 5;13(1):23. doi: 10.1186/1475-925X-13-23.</citation>
    <PMID>24597518</PMID>
  </results_reference>
  <results_reference>
    <citation>Nederhand MJ, Van Asseldonk EH, van der Kooij H, Rietman HS. Dynamic Balance Control (DBC) in lower leg amputee subjects; contribution of the regulatory activity of the prosthesis side. Clin Biomech (Bristol, Avon). 2012 Jan;27(1):40-5. doi: 10.1016/j.clinbiomech.2011.07.008. Epub 2011 Sep 1.</citation>
    <PMID>21889241</PMID>
  </results_reference>
  <results_reference>
    <citation>Buckley JG, O'Driscoll D, Bennett SJ. Postural sway and active balance performance in highly active lower-limb amputees. Am J Phys Med Rehabil. 2002 Jan;81(1):13-20. doi: 10.1097/00002060-200201000-00004.</citation>
    <PMID>11807327</PMID>
  </results_reference>
  <results_reference>
    <citation>Goh JC, Solomonidis SE, Spence WD, Paul JP. Biomechanical evaluation of SACH and uniaxial feet. Prosthet Orthot Int. 1984 Dec;8(3):147-54. doi: 10.3109/03093648409146077.</citation>
    <PMID>6522257</PMID>
  </results_reference>
  <results_reference>
    <citation>Quesada PM, Pitkin M, Colvin J. Biomechanical evaluation of a prototype foot/ankle prosthesis. IEEE Trans Rehabil Eng. 2000 Mar;8(1):156-9. doi: 10.1109/86.830960.</citation>
    <PMID>10779119</PMID>
  </results_reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>June 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 13, 2017</last_update_submitted>
  <last_update_submitted_qc>August 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prosthetic feet</keyword>
  <keyword>double blind study</keyword>
  <keyword>limited ambulators</keyword>
  <keyword>SACH foot</keyword>
  <keyword>prosthetic components comparison</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03249883
org study id: 0027-14-LOE
nct id: NCT03249883
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to determine whether the geriatric prosthetic foot 1M10 is
      superior to the classical SACH (Solid Ankle Cushion Heel) foot, when used by indoor
      ambulators with a transtibial amputation.
Fourteen limited ambulators , unilateral trans tibial amputees, will be recruited in the
      orthopedic rehabilitation department in our institute. Participants will be assigned randomly
      to be fitted with a SACH or a 1M10 Otto Bock foot in their prosthesis.

      Both types of feet will be "dressed" to look similarly. All participants will receive the
      same rehabilitation protocol. After three weeks all participants will be tested functionally
      in the "10 meter walk test" , and a "Get up and go test". The participants will answer a
      satisfaction questionnaire that is based on the "Prosthesis Evaluation Questionnaire" and
      modified according to the aims of this trial.

      Pressure patterns and gait parameters will be recorded using a pressure mat. At this time the
      foot will be switched to the other study prosthetic foot, and the rehabilitation will
      commence.

      At the end of three weeks wearing the new foot the same set of tests will be run again.

      The investigators aim to present the difference in satisfaction and in the functional
      performance of the same participant wearing the two feet.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Prosthetic satisfaction Questionnaire
time frame: Measured after 3 weeks
description: Hebrew satisfaction questionnaire
measure: 10 meter walk test
time frame: Measured after 3 weeks
description: The participants will be asked to walk at their comfort pace 10 meters. The time of completing the task will be recorded
measure: Get up and go test
time frame: Measured after 3 weeks
description: The participants will be asked to get up from a chair walk 3 meters turn around walk back to the chair and sit down. The time of completing the task will be recorded.
measure: Prosthetic Satisfaction Questionnaire
time frame: Measured after 6 weeks
description: Hebrew satisfaction questionnaire
measure: 10 meter walk test
time frame: Measured after 6 weeks
description: The participants will be asked to walk at their comfort pace 10 meters. The time of completing the task will be recorded
measure: Get up and go test
time frame: Measured after 6 weeks
description: The participants will be asked to get up from a chair walk 3 meters turn around walk back to the chair and sit down. The time of completing the task will be recorded
measure: Gait patterns
time frame: Measured after 3 weeks and
description: Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.
measure: Gait patterns
time frame: Measured after 6 weeks
description: Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.
arm group label: SACH first
arm group type: Active Comparator
description: Will use a SACH foot for the first three weeks of prosthetic gait training , and a 1M10 foot for the second three weeks of prosthetic gait training
arm group label: 1M10 first
arm group type: Active Comparator
description: Will use a 1M10 foot for the first three weeks of prosthetic gait training , and a SACH foot for the second three weeks of prosthetic gait training
intervention type: Device
intervention name: SACH prosthetic foot, 1M10 prosthetic foot
description: In the SACH first group - the amputees will wear the SACH feet for three weeks and then switch to 1M10 feet for another three weeks.
In the 1M10 first group - the amputees will wear the 1M10 feet for three weeks and then switch to SACH feet for another three weeks.
arm group label: 1M10 first
arm group label: SACH first
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hagay Amir, MD
role: Principal Investigator
affiliation: Director of Orthopedic rehabilitation Department
last name: Hagay Amir, MD
phone: 972-50-6263379
email: hagayam@clalit.org.il
citation: Chitragari G, Mahler DB, Sumpio BJ, Blume PA, Sumpio BE. Prosthetic options available for the diabetic lower limb amputee. Clin Podiatr Med Surg. 2014 Jan;31(1):173-85. doi: 10.1016/j.cpm.2013.09.008.
PMID: 24296024
citation: Agrawal V, Gailey RS, Gaunaurd IA, O'Toole C, Finnieston A, Tolchin R. Comparison of four different categories of prosthetic feet during ramp ambulation in unilateral transtibial amputees. Prosthet Orthot Int. 2015 Oct;39(5):380-9. doi: 10.1177/0309364614536762. Epub 2014 Jun 12.
PMID: 24925671
citation: Bonnet X, Adde JN, Blanchard F, Gedouin-Toquet A, Eveno D. Evaluation of a new geriatric foot versus the Solid Ankle Cushion Heel foot for low-activity amputees. Prosthet Orthot Int. 2015 Apr;39(2):112-8. doi: 10.1177/0309364613515492. Epub 2014 Jan 13.
PMID: 24418934
citation: Graham LA, Fyfe NC. Prosthetic rehabilitation of amputees aged over 90 is usually successful. Disabil Rehabil. 2002 Sep 10;24(13):700-1. doi: 10.1080/09638280210142194.
PMID: 12296985
citation: Vickers DR, Palk C, McIntosh AS, Beatty KT. Elderly unilateral transtibial amputee gait on an inclined walkway: a biomechanical analysis. Gait Posture. 2008 Apr;27(3):518-29. doi: 10.1016/j.gaitpost.2007.06.008. Epub 2007 Aug 17.
PMID: 17707643
citation: Edelstein JE. Prosthetic feet. State of the Art. Phys Ther. 1988 Dec;68(12):1874-81. doi: 10.1093/ptj/68.12.1874.
PMID: 3057523
citation: Hansen A, Sam M, Childress D. The effective foot length ratio: a potential tool for characterization and eval¬uation of prosthetic feet. J Prosthet Orthot 2004; 16(2): 41-45.
citation: Hansen AH, Meier MR, Sessoms PH, Childress DS. The effects of prosthetic foot roll-over shape arc length on the gait of trans-tibial prosthesis users. Prosthet Orthot Int. 2006 Dec;30(3):286-99. doi: 10.1080/03093640600816982.
PMID: 17162519
citation: Arifin N, Abu Osman NA, Ali S, Wan Abas WA. The effects of prosthetic foot type and visual alteration on postural steadiness in below-knee amputees. Biomed Eng Online. 2014 Mar 5;13(1):23. doi: 10.1186/1475-925X-13-23.
PMID: 24597518
citation: Nederhand MJ, Van Asseldonk EH, van der Kooij H, Rietman HS. Dynamic Balance Control (DBC) in lower leg amputee subjects; contribution of the regulatory activity of the prosthesis side. Clin Biomech (Bristol, Avon). 2012 Jan;27(1):40-5. doi: 10.1016/j.clinbiomech.2011.07.008. Epub 2011 Sep 1.
PMID: 21889241
citation: Buckley JG, O'Driscoll D, Bennett SJ. Postural sway and active balance performance in highly active lower-limb amputees. Am J Phys Med Rehabil. 2002 Jan;81(1):13-20. doi: 10.1097/00002060-200201000-00004.
PMID: 11807327
citation: Goh JC, Solomonidis SE, Spence WD, Paul JP. Biomechanical evaluation of SACH and uniaxial feet. Prosthet Orthot Int. 1984 Dec;8(3):147-54. doi: 10.3109/03093648409146077.
PMID: 6522257
citation: Quesada PM, Pitkin M, Colvin J. Biomechanical evaluation of a prototype foot/ankle prosthesis. IEEE Trans Rehabil Eng. 2000 Mar;8(1):156-9. doi: 10.1109/86.830960.
PMID: 10779119
responsible party type: Sponsor
sharing ipd: No