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Criteria for Advanced Prosthetic Foot Prescription

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ClinicalTrials.gov Identifier: NCT03505983
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
James A. Haley Veterans Administration Hospital
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Jason Maikos, VA New York Harbor Healthcare System

Brief Summary:
The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2) Correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR, articulating ESR, and active plantar flexion ESR ankle-foot units.

Condition or disease Intervention/treatment Phase
Prosthesis User Amputation; Traumatic, Limb, Lower Device: ESR Prosthetic Foot First Device: Articulating ESR Prosthetic Foot First Device: Powered Prosthetic Foot First Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Criteria for Advanced Prosthetic Foot Prescription
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Active Comparator: ESR Prosthetic Foot First
Subject will start with an energy storing and returning (ESR) prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot, and a powered prosthetic foot for 1 week. During the final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
Device: ESR Prosthetic Foot First
Subjects will start with an ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.

Active Comparator: Articulating ESR Prosthetic Foot First
Subjects will start with an Articulating ESR prosthetic foot first for 1 week, then will complete an additional week with the ESR prosthetic foot, and a powered prosthetic foot for 1 week.The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities.
Device: Articulating ESR Prosthetic Foot First
Subjects will start with an articulating ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
Other Names:
  • Odyssey (College Park)
  • Elan (Endolite)
  • MotionFoot (Fillauer)
  • Proflex (Ossur)
  • Echelon (Endolite)
  • Tribute (College Park)
  • Proprio (Ossur)
  • TruStep (College Park)
  • Kinterra (Freedom Innovations)
  • Flex Foot Balance with DP Flexion (Ossur)
  • Raize (Fillauer)
  • Echelon VT (Endolite)
  • Triton Smart Ankle (Otto Bock)
  • Venture (College Park)
  • Kinnex (Freedom Innovations)

Active Comparator: Powered Prosthetic Foot First
Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot and an ESR prosthetic foot for 1 week. The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities.
Device: Powered Prosthetic Foot First
Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR foot and an ESR foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
Other Name: emPOWER (Otto Bock)




Primary Outcome Measures :
  1. Change in 6-min walk distance for each prosthetic foot type [ Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment ]
    The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.

  2. Change in TUG times for each prosthetic foot type [ Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment ]
    The TUG measures the time taken by an individual to stand up from a standard arm chair, walk a distance of 10 feet, turn, walk back to the chair, and sit down.

  3. Change in 4SST times for each prosthetic foot type [ Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment ]
    The four-square step test is a higher order complex task assessing dynamic balance.

  4. Change in AmpPRO for each prosthetic foot type [ Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment ]
    The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.

  5. Change in Stair Assessment Index (SAI) for each prosthetic foot type [ Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment ]
    The SAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a staircase.

  6. Change in Hill Assessment Index (HAI) for each prosthetic foot type [ Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment ]
    The HAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a ramp.

  7. Change in Gait Evaluation for each prosthetic foot type [ Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment ]
    Biomechanical evaluation of gait.


Secondary Outcome Measures :
  1. Change in Prosthetic Evaluation Questionnaire (PEQ) score for each prosthetic foot type [ Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment ]
    The PEQ is a self-report Visual Analog Scale questionnaires for persons with lower limb amputations who use a prosthesis. It consists of 9 validated subscales. They are used to evaluate the prosthesis and life with the prosthesis. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line to the point at which the respondent's mark crosses the line. Each line is 100 mm long and is always measured from the left (0-100). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response. Subscale scores are calculated by computing the average (arithmetic mean) of all the questions which make up that particular scale. Only subscales are calculated. A total combined score is not calculated.

  2. Change in Short Form (SF)-12 for each prosthetic foot type [ Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment ]
    The SF-12 is a questionnaire used to measure the relationship between physical and mental health functioning and the social determinants of health. It is a self-reported questionnaire, on a rating scale, called a Likert Scale. The participant taking this questionnaire will check one response box per question. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Age-specific mean difference score (difference score) is calculated and is the amount by which a person's score differs from their age group's mean score. By looking at difference scores, it is clear whether a person is more or less healthy than other persons in his or her comparison group.

  3. Change in OPUS for each prosthetic foot type [ Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment ]
    OPUS is a set of self-report instruments that assess functional status, quality of life, and satisfaction with devices and services that can be used in an orthotics and prosthetics clinic. The OPUS Health Quality of Life Score is the sum of the scores for the 23 items (0 - 92). The OPUS lower extremity total score is the sum of the scores for the 20 items (0 - 80). OPUS Satisfaction With Device Score is the sum of the scores for items 1-11 (11 - 55). Satisfaction With Services Score is the sum of the scores for items 12-21 (10 - 50). A higher score indicates a better outcome for all measures.

  4. Final Visit Guided Interview [ Time Frame: Administered one time at Final Visit, which will occur 7 weeks after enrollment. ]
    Final Visit questionnaire to evaluate subjective preferences. This is a free response questionnaire, in which the participant can answer in open-ended format.

  5. Change in responses to Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) for each prosthetic foot type [ Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment ]
    The PEQ-A is a free response 2-question questionnaire, in which the participant is asked whether and how many times they had experienced a fall or near-fall in the previous week using the particular prosthetic foot.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • DEERS eligible Veteran or Service Member with unilateral transtibial amputation
  • Currently using an Energy Storing and Returning prosthetic foot with a well-fitting socket as a primary or back-up prosthesis
  • Achieved a "No Helper" score of 5, 6, or 7 on the Functional Independence Measure (FIM) for the locomotion mobility items
  • Has a minimum clearance of 8 ¾ inches to accommodate all feet

Exclusion Criteria:

  • Has active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair their ability to participate in all functional outcome measures
  • Has any comorbidity that results in rapid limb volume changes (i.e. end stage renal disease with dialysis),
  • Weighs more than 275 pounds, the maximum product weight load
  • Is unable or unwilling to comply with all research visits
  • Has cognitive deficit(s) or mental health pathology limiting a subject's ability to participate fully in the study
  • Women who are pregnant. This will be determined by asking the participant if they are pregnant or if they believe that they may be pregnant. This question will only be asked at inclusion, as biomechanical changes will only be impacted if the woman is in the 2nd or 3rd trimester, and will not be impacted if the participant becomes pregnant while in the study.
  • Poorly fitting socket
  • Potential participants with knee flexion contracture > 5 degrees
  • Vision loss that requires use of an assistive device for gait
  • Upper Limb Amputation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505983


Contacts
Contact: Michael Hyre, MS 212-951-3339 michael.hyre@va.gov

Locations
United States, New York
VA New York Harbor Healthcare System Recruiting
New York, New York, United States, 10010
Contact: Michael Hyre, MS    212-951-3339    michael.hyre@va.gov   
Principal Investigator: Jason Maikos, PhD         
Sponsors and Collaborators
VA New York Harbor Healthcare System
Walter Reed National Military Medical Center
James A. Haley Veterans Administration Hospital
VA Puget Sound Health Care System
Investigators
Principal Investigator: Jason Maikos, PhD Director, VISN 2 Gait and Motion Analysis Laboratory

Responsible Party: Jason Maikos, Director, VISN 2 Gait and Motion Analysis Laboratory, VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier: NCT03505983     History of Changes
Other Study ID Numbers: IRB #01603
Award Number W81XWH-17-2-0014 ( Other Grant/Funding Number: DoD )
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jason Maikos, VA New York Harbor Healthcare System:
Prosthetic Limb Design
Prosthesis Fitting

Additional relevant MeSH terms:
Amputation, Traumatic
Leg Injuries
Wounds and Injuries