A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations

NCT03651830 | Completed

• 2 other identifiers: MD13W81XWH-16-1-056
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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). After participants complete the procedures detailed above, they may be eligible to be invited to participate in follow-up phone interviews. A subset of participants may also be invited to participate in follow-up biomechanical data collection comparing the PFE foot conditions to the respective actual prosthetic feet during walking. Additionally, a subset of participants may also be invited to participate in follow-up data collection comparing prosthetic foot conditions of different stiffness categories.

Conditions

Amputation

Keywords

Amputation; Rehabilitation; Prescriptions; Emulator; Prosthetics

Outcome Measures

Primary Outcomes (5)

• Foot Preference Survey

  Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.

  Administered during initial testing with prosthetic foot emulator (approximately 2 hours).

• Foot Preference Survey

  Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.

  Administered during initial testing with actual prosthetic feet (approximately 2 hours).

• Foot Preference Survey

  Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.

  Administered at 2-week follow up for prosthetic foot A.

• Foot Preference Survey

  Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.

  Administered at 2-week follow up for prosthetic foot B.

• Foot Preference Survey

  Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.

  Administered at 2-week follow up for prosthetic foot C.

Secondary Outcomes (9)

• Two Minute Walk Test

  Administered at baseline and at 2-week follow up for each foot condition.

• Prosthetic Limb Users Survey of Mobility (PLUS-M), tailored short-form

  Administered at baseline and at 2-week follow up for each foot condition.

• Activities Specific Balance Confidence Scale (ABC)

  Administered at baseline and at 2-week follow up for each foot condition.

• Trinity Amputation and Prosthesis Experience Scales (TAPES)

  Administered at baseline and at 2-week follow up for each foot condition.

• Four Square Step Test (FSST)

  Administered at baseline and at 2-week follow up for each foot condition.

Study Arms (2)

Prosthetic Foot Emulator

EXPERIMENTAL

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

Commercially available prosthetic feet

ACTIVE COMPARATOR

Participants will walk under different walking conditions using three different commercial prosthetic feet.

Device: Commercially available prosthetic feet

Interventions

Prosthetic Foot Emulator DEVICE

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.

Prosthetic Foot Emulator

Commercially available prosthetic feet DEVICE

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.

Commercially available prosthetic feet

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• VA Puget Sound Health Care System: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator
• Brooke Army Medical Center: collaborator
• Stanford University: collaborator
• University of Washington: collaborator

Study Sites (3)

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Center for the Intrepid

San Antonio, Texas, 78234, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Study Officials

• David Morgenroth, MD

  VA Puget Sound Health Care System and SIBCR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 29, 2018
• Study Start: September 24, 2018
• Primary Completion: May 20, 2021
• Study Completion: June 14, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)