Back to resultsCriteria for Advanced Prosthetic Foot Prescription
Primary Purpose
Prosthesis User, Amputation; Traumatic, Limb, Lower
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ESR Prosthetic Foot First
Articulating ESR Prosthetic Foot First
Powered Prosthetic Foot First
Sponsored by
About this trial
This is an interventional supportive care trial for Prosthesis User focused on measuring Prosthetic Limb Design, Prosthesis Fitting
Eligibility Criteria
Inclusion Criteria:
- DEERS eligible Veteran or Service Member, or civilian 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 "Modified Independence" score 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 or plan to become pregnant during study activities. 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
- Vision loss that requires use of an assistive device for gait
- Upper Limb Amputation
Sites / Locations
- VA New York Harbor Healthcare SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
ESR Prosthetic Foot First
Articulating ESR Prosthetic Foot First
Powered Prosthetic Foot First
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Change in 6-min walk distance for each prosthetic foot type
The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.
Change in TUG times for each prosthetic foot type
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.
Change in 4SST times for each prosthetic foot type
The four-square step test is a higher order complex task assessing dynamic balance.
Change in AmpPRO for each prosthetic foot type
The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.
Change in Stair Assessment Index (SAI) for each prosthetic foot type
The SAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a staircase.
Change in Hill Assessment Index (HAI) for each prosthetic foot type
The HAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a ramp.
Change in Gait Evaluation for each prosthetic foot type
Biomechanical evaluation of gait.
Secondary Outcome Measures
Change in Prosthetic Evaluation Questionnaire (PEQ) score for each prosthetic foot type
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.
Change in Short Form (SF)-12 for each prosthetic foot type
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.
Change in OPUS for each prosthetic foot type
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.
Final Visit Guided Interview
Final Visit questionnaire to evaluate subjective preferences. This is a free response questionnaire, in which the participant can answer in open-ended format.
Change in responses to Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) for each prosthetic foot type
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.
Full Information
NCT ID
NCT03505983
First Posted
March 7, 2018
Last Updated
January 9, 2023
Sponsor
VA New York Harbor Healthcare System
Collaborators
Walter Reed National Military Medical Center, James A. Haley Veterans Administration Hospital, VA Puget Sound Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT03505983
Brief Title
Criteria for Advanced Prosthetic Foot Prescription
Official Title
Criteria for Advanced Prosthetic Foot Prescription
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA New York Harbor Healthcare System
Collaborators
Walter Reed National Military Medical Center, James A. Haley Veterans Administration Hospital, VA Puget Sound Health Care System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis User, Amputation; Traumatic, Limb, Lower
Keywords
Prosthetic Limb Design, Prosthesis Fitting
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessor and statistician will be blinded to foot type during data processing and analysis
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESR Prosthetic Foot First
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Articulating ESR Prosthetic Foot First
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Powered Prosthetic Foot First
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ESR Prosthetic Foot First
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Articulating ESR Prosthetic Foot First
Other Intervention Name(s)
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)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Powered Prosthetic Foot First
Other Intervention Name(s)
emPOWER (Otto Bock)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 6-min walk distance for each prosthetic foot type
Description
The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.
Time Frame
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Title
Change in TUG times for each prosthetic foot type
Description
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.
Time Frame
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Title
Change in 4SST times for each prosthetic foot type
Description
The four-square step test is a higher order complex task assessing dynamic balance.
Time Frame
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Title
Change in AmpPRO for each prosthetic foot type
Description
The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.
Time Frame
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Title
Change in Stair Assessment Index (SAI) for each prosthetic foot type
Description
The SAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a staircase.
Time Frame
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Title
Change in Hill Assessment Index (HAI) for each prosthetic foot type
Description
The HAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a ramp.
Time Frame
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Title
Change in Gait Evaluation for each prosthetic foot type
Description
Biomechanical evaluation of gait.
Time Frame
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Secondary Outcome Measure Information:
Title
Change in Prosthetic Evaluation Questionnaire (PEQ) score for each prosthetic foot type
Description
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.
Time Frame
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Title
Change in Short Form (SF)-12 for each prosthetic foot type
Description
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.
Time Frame
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Title
Change in OPUS for each prosthetic foot type
Description
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.
Time Frame
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Title
Final Visit Guided Interview
Description
Final Visit questionnaire to evaluate subjective preferences. This is a free response questionnaire, in which the participant can answer in open-ended format.
Time Frame
Administered one time at Final Visit, which will occur 7 weeks after enrollment.
Title
Change in responses to Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) for each prosthetic foot type
Description
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.
Time Frame
Once per week, at Week 1, Week 2, and Week 3 after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
DEERS eligible Veteran or Service Member, or civilian 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 "Modified Independence" score 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 or plan to become pregnant during study activities. 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
Vision loss that requires use of an assistive device for gait
Upper Limb Amputation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Hyre, MS
Phone
212-951-3339
Email
michael.hyre@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Maikos, PhD
Organizational Affiliation
Director, VISN 2 Gait and Motion Analysis Laboratory
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA New York Harbor Healthcare System
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Hyre, MS
Phone
212-951-3339
Email
michael.hyre@va.gov
First Name & Middle Initial & Last Name & Degree
Jason Maikos, PhD
12. IPD Sharing Statement
Learn more about this trial
Criteria for Advanced Prosthetic Foot Prescription
We'll reach out to this number within 24 hrs