A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Amputation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 89 years
- Gender
- Both males and females
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 impo...
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. The investigators will also evaluate the experiences of prosthetic foot prescription practices using qualitative methods from follow-up phone interviews with participants. Finally, the investigators will evaluate biomechanical outcomes during walking between the PFE and actual prosthetic feet to examine the ability of the emulator to accurately reproduce the experience of walking with the actual feet. 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.
Tracking Information
- NCT #
- NCT03651830
- Collaborators
- VA Puget Sound Health Care System
- Minneapolis Veterans Affairs Medical Center
- Brooke Army Medical Center
- Stanford University
- University of Washington
- Investigators
- Principal Investigator: David Morgenroth, MD VA Puget Sound Health Care System and SIBCR