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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
Sponsor:
Collaborators:
VA Puget Sound Health Care System
Minneapolis Veterans Affairs Medical Center
Brooke Army Medical Center
Stanford University
University of Washington
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

Brief Summary:

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

Detailed Description:
Objectives and Rationale: Using a prosthesis allows many who experience lower leg amputation to regain functional abilities, but walking may be more difficult, and a sub-optimal prosthesis can substantially restrict participation in desired activities. Selecting an optimal prosthetic foot is an important aspect of maximizing mobility and the achievement of functional goals for people with lower leg amputation, however there is limited evidence to guide this process. The current prosthetic prescription process relies on clinician experience and typically does not allow people with a leg amputation to easily try out different prosthetic feet. The investigators have developed a customizable robotic prosthetic foot that mimics the mechanical properties of commercially available prosthetic feet without physically changing feet. This 'prosthetic foot emulator' (PFE) can be attached to the prescribed prosthetic socket and worn like a regular prosthetic foot within the laboratory or clinic, providing people with leg amputations the opportunity to quickly 'test-drive' many prosthetic foot designs within a single test session. Trial and error with actual commercial prosthetic feet can be inefficient given the time and expense required for the purchasing and fitting of prosthetic feet. The PFE could provide a means to explore a range of feet in a very short period of time. This study will evaluate the ability of the emulator to accurately reproduce the experience of wearing several commercially available (actual) prosthetic feet. The investigators will test whether brief in-laboratory experiences with emulated or actual feet can accurately predict longer-term foot preference, satisfaction, and walking ability in the community. Results from this study may provide evidence to support a new approach to prosthesis prescription and could resolve longstanding uncertainty in the prescription process for prosthetic feet.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Foot Preference Survey [ Time Frame: Administered at 2-week follow up for prosthetic foot B. ]
    Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.

  5. Foot Preference Survey [ Time Frame: Administered at 2-week follow up for prosthetic foot C. ]
    Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • has a unilateral (one leg) transtibial (below-knee) amputation
  • has used a prosthetic limb for walking for at least six months
  • has a comfortably fitting prosthetic socket
  • be able to walk with a prosthetic limb sufficiently to participate in the experiment walking trials
  • be age 18 to 89 years

Exclusion Criteria:

  • contralateral limb or upper limb amputation
  • are unable to use test feet for any reason (e.g., excessively long residual limb that is not compatible with wearing study prosthetic feet)
  • unable to walk under the minimal necessary study walking conditions in order to complete the study procedures without undo stress
  • currently pregnant (determined via self-report during screening)
  • current surgical, neurological, rheumatologic, or lower limb musculoskeletal problem that significantly impairs ambulation (e.g., current ulcer, terminal illness, lower extremity joint replacement)
  • weight greater than 250lbs.
  • inadequate cognitive or language function to consent to participate
  • currently incarcerated

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): NCT03651830


Contacts
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Contact: Beth Halsne, CPO 2062771217 bhalsne@uw.edu

Locations
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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    andrea.j.ikeda.civ@mail.mil   
United States, Washington
VA Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Beth Halsne, CPO    206-277-1217    bhalsne@uw.edu   
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
VA Puget Sound Health Care System
Minneapolis Veterans Affairs Medical Center
Brooke Army Medical Center
Stanford University
University of Washington
Investigators
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Principal Investigator: David Morgenroth, MD VA Puget Sound Health Care System and SIBCR

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Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT03651830     History of Changes
Other Study ID Numbers: MD13
W81XWH-16-1-056 ( Other Grant/Funding Number: Department of Defense )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
Amputation
Rehabilitation
Prescriptions
Emulator
Prosthetics