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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
91
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.
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.
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.
VA New York Harbor Healthcare System
New York, New York, United States
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.
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
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.
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in 4SST times for each prosthetic foot type
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
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.
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
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.
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
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.
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in Gait Evaluation for each prosthetic foot type
Biomechanical evaluation of gait.
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
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.
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
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.
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
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.
Time frame: Administered one time at Final Visit, which will occur 7 weeks after enrollment.
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.
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment