A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations
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|ClinicalTrials.gov Identifier: NCT03651830|
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : February 28, 2019
Objective/Hypotheses and Specific Aims: The primary aim of this proposal is to determine whether a PFE can be used to predict foot preference and mobility outcomes with corresponding commercial prosthetic feet in people with a unilateral transtibial amputation (TTA). Secondarily, the investigators aim to determine whether a brief trial of commercial prosthetic feet would be able to similarly predict longer-term foot preference and mobility outcomes with those feet.
Study Design: The investigators will use a participant blinded cross-over study with repeated measurements. Participants with TTA will be enrolled at each of the three study sites: two VA sites (Puget Sound and Minneapolis), and one Department of Defense site (Center for the Intrepid). Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the high or low mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests in the laboratory. During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if Day 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately two weeks. At visit 4 participants will be fit with the next actual foot and repeat the 2 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6. Participants' preference, satisfaction and perceived mobility, and functional mobility will be measured and compared across all foot conditions (emulated and actual).
|Condition or disease||Intervention/treatment||Phase|
|Amputation||Device: Prosthetic Foot Emulator Device: Commercially available prosthetic feet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Prosthetic Foot Emulator to Optimize Prescription of Prosthetic Feet in Veterans and Service Members With Leg Amputations|
|Actual Study Start Date :||September 24, 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Prosthetic Foot Emulator
The Prosthetic Foot Emulator (PFE) is a customizable robotic prosthetic foot that can mimic commercial feet to predict how individual patients will respond to candidate feet. Participants will walk with the PFE using three different modes (emulating three commercial feet) under different walking conditions.
Device: Prosthetic Foot Emulator
Participants will walk in the laboratory with the Prosthetic Foot Emulator (PFE) in three foot modes corresponding to actual study feet. Walking conditions will include self-selected speed, slow speed, fast speed, incline, and up stairs.
Active Comparator: Commercially available prosthetic feet
Participants will walk under different walking conditions using three different commercial prosthetic feet.
Device: Commercially available prosthetic feet
Participants will walk in the laboratory with three different commercially available prosthetic feet. Walking conditions will include self-selected speed, slow speed, fast speed, incline, and up stairs.
Additionally, participants will be fit with one of the actual feet and wear it at home and in the community for approximately two weeks. This will be followed by two-week periods in the community with each of the other two commercially available prosthetic feet.
- Foot Preference Survey [ Time Frame: Administered during initial testing with prosthetic foot emulator (approximately 2 hours). ]Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
- Foot Preference Survey [ Time Frame: Administered during initial testing with actual prosthetic feet (approximately 2 hours). ]Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
- Foot Preference Survey [ Time Frame: Administered at 2-week follow up for prosthetic foot A. ]Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
- Foot Preference Survey [ Time Frame: Administered at 2-week follow up for prosthetic foot B. ]
- Foot Preference Survey [ Time Frame: Administered at 2-week follow up for prosthetic foot C. ]
- Two Minute Walk Test [ Time Frame: Administered at baseline and at 2-week follow up for each foot condition. ]Participants are asked to walk for 2 minutes at their fastest possible speed and distance walked is recorded.
- Prosthetic Limb Users Survey of Mobility (PLUS-M), tailored short-form [ Time Frame: Administered at baseline and at 2-week follow up for each foot condition. ]Standardized self-report item bank.
- Activities Specific Balance Confidence Scale (ABC) [ Time Frame: Administered at baseline and at 2-week follow up for each foot condition. ]This is a subjective measure of confidence in performing ambulatory activities without falling or feeling unsteady. The investigators are using a revised version of the ABC recommended to ease administration and improve scoring. Questions answered on 0-4 scale (0 = No Confidence; 4 = Complete Confidence). Scores for 16 questions combined and averaged.
- Trinity Amputation and Prosthesis Experience Scales (TAPES) [ Time Frame: Administered at baseline and at 2-week follow up for each foot condition. ]Multidimensional health instrument that measures self-reported activity restrictions (TAPES-AR) and satisfaction with the function (TAPES-FUN) of a prosthesis. Other subscales of TAPES will not be used. Questions answered on 0-2 scale (0 = No, not limited; 2 = Yes, limited a lot for TAPES-AR, and 0= Not satisfied; 2 = Very satisfied for TAPES-FUN). Subscales will be scored separately. For TAPES-AR, scores of all items answered will be combined and averaged. For TAPES-FUN, scores for all items will be added together.
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): NCT03651830
|Contact: Beth Halsne, CPOfirstname.lastname@example.org|
|United States, Minnesota|
|Minneapolis VA Medical Center||Not yet recruiting|
|Minneapolis, Minnesota, United States, 55417|
|Contact: Alana Cataldo, BS 612-467-4705 Alana.Cataldo@va.gov|
|United States, Texas|
|Center for the Intrepid||Not yet recruiting|
|San Antonio, Texas, United States, 78234|
|Contact: Andrea Ikeda, CPO 210-916-6100 email@example.com|
|United States, Washington|
|VA Puget Sound Health Care System||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Beth Halsne, CPO 206-277-1217 firstname.lastname@example.org|
|Principal Investigator:||David Morgenroth, MD||VA Puget Sound Health Care System and SIBCR|