A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 3/2/2019 |
| Start Date: | September 24, 2018 |
| End Date: | September 2020 |
| Contact: | Beth Halsne, CPO |
| Email: | bhalsne@uw.edu |
| Phone: | 2062771217 |
A Prosthetic Foot Emulator to Optimize Prescription of Prosthetic Feet in Veterans and Service Members With Leg Amputations
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).
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).
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.
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.
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
We found this trial at
3
sites
1660 South Columbian Way
Seattle, Washington 98108
Seattle, Washington 98108
(206) 762-1010
Phone: 206-277-1217
VA Puget Sound Health Care System With a reputation for excellence, innovation and extraordinary care...
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