An Adaptable Foot Prosthesis for People With Lower Extremity Amputations - Community Experiences
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Ambulation Sub-Scale
Study Overview
Brief Summary
The purpose of the study is to obtain performance measurements and participant feedback about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot. To accomplish this, the study will use a combination of laboratory motion analysis, functional tests, and community mobility trials where participants complete questionnaires and interviews about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot.
Individuals with amputations that participate in the (optional) motion analysis sub-study at the University of Washington will complete forward walking, side-step, and across river rock with usual foot (session 1), and also with the investigational foot locked and unlocked (session 2) after an accommodation period of between 1-4 weeks. The participants will rate their experiences using socket comfort score and the socket pressure score.
Control participants recruited at the University of Washington to provide information about performance for people without amputation will go through the consenting process, then will be asked to complete forward walking, Figure-of-8 Walk Test, Narrowing Beam Walking Test, side-step, and walking across river rock surface. These tests will be conducted at a single session.
Detailed Description
If the participant with an amputation is eligible and wishes to participate, an appointment will be made for the person to come to the University of Washington Motion Analysis Lab or WillowWood, in Mt. Sterling, Ohio. The participant will meet with a researcher and clinical prosthetist to go through the consenting process. At that time, participants will complete the demographic data questionnaire.
The prosthetist will assess the condition and fit of the participant's current prosthesis for alignment, fit, and condition. The prosthetist will also inspect the participant's residual limb for skin condition. People presenting with significant skin breakdown will not be eligible to participate. The prosthetist will also determine how best to set up the current socket system with the investigational foot at that time.
Motion analysis trials of the investigational foot compared to the participant's usual foot. Participants will complete forward walking, side-step, and across river rock with usual foot (session 1), and also with the investigational foot locked and unlocked (session 2) after an accommodation period of between 1-4 weeks. The UW will conduct optically-based motion analysis using an 8-camera Qualisys motion capture system 4 embedded tri-axial ground reaction force platforms and a river rock-substrate surface that is parallel to the main motion capture space. For all motion analysis tests, retroreflective markers are taped to anatomical landmarks that are compatible with Visual 3-D kinematic modeling software. Motion data are captured at 120 Hz.
Motion Analysis Tests Forward walking. Participants will walk at a self-selected speed on a level surface for 10 m. In the center of the calibrated walking area, the participant will step on force plates. Marker position and reaction forces will be recorded for 2 sequential steps of the prosthetic side for participants with amputations, or matched side for control subjects. After a practice test, 3 tests where the prosthetic side successfully contacts the force plates will be recorded.
Side-step. Participants will perform the test in a similar manner to forward walking but will instead move laterally over the 10 m surface and across the centrally placed force plates. The order of side-stepping to the right or left will be randomly assigned. Participants will be asked not to cross-over their feet. After a practice test, 3 tests in each direction, where the prosthetic side or matched side successfully contacts the force plates, will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 85 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Unilateral below knee amputation, use a prosthetic foot for at least 1 year
- •Ability to walk 400 meters on level ground without using a walking aid and without an increase in pain
- •Ability to read, write, and comprehend English
Exclusion Criteria
- •Residual skin breakdown
- •Weight over 300 lbs
Outcomes
Primary Outcomes
Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Ambulation Sub-Scale
Time Frame: Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.
Self-report questionnaire. PEQ Subscales: The PEQ is a 9-scale instrument that has good psychometric properties and has been validated. The PEQ subscales have a range from 0 (worst) to 100 (best). PEQ subscales of residual limb health, ambulation, utility, and sounds were selected for this study and comprise a total of 24 visual analogue scale questions. ICC estimates for these subscales for the first and second administration ranged from 0.79 to 0.9.
Difference Between Investigational Foot and Usual Foot in the Figure-of-8 Walking Test: Time
Time Frame: Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.
The F8W was developed to represent walking skills used in everyday life, involving straight and curved paths in both right and left directions. It has been validated in older adult populations with mobility disability. Subjects will begin the task standing between the 2 cones. The subject will walk a figure 8 course 3 times for each condition at their self-selected pace and stop when they return to the start position. The outcomes of the test are the time to complete the course.
Difference Between Investigational Foot and Usual Foot in the Comprehensive Lower Extremity Amputee Socket Survey (CLASS): Comfort Scale
Time Frame: Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.
The intent of the CLASS is to provide greater insight into the cause of socket dissatisfaction compared to the Socket Comfort Score. To accomplish this, the CLASS includes 4 subcategories; 1) stability, 2) suspension, 3) comfort, and 4) appearance. Each subcategory contains 3-4 items scored using a 5-point scale that relate to common tasks such as standing, sitting, walking, and ascending and descending stairs. Scale range: 0-60 Values: 0 = worst outcome; 60 = best outcome Subscales:0-16
Difference Between Investigational Foot and Usual Foot in the Daily Activity Log: Scale Measuring How Prosthesis Helps or Hinders When Walking on a Challenging Surface
Time Frame: Daily for 2-4 weeks
Difference between investigational foot and usual foot of the average daily values of the visual analog scale of participant's perception of gait on challenging surface. Scale range: 0-100 Values: 0 = worst outcome; 100 = best outcome
Secondary Outcomes
- Difference Between Investigational Foot and Usual Foot in the Comprehensive Lower Extremity Amputee Socket Survey (CLASS): Suspension Subscales(Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.)
- Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Residual Limb Health Subscale(Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.)
- Difference Between Investigational Foot and Usual Foot in the Narrowing Beam Walking Test: Distance Travelled(Baseline (A1), after 2-week trial of investigational foot (B). Primary analysis uses B minus A1.)
- Difference Between Investigational Foot and Usual Foot in the Daily Activity Log: Balance Confidence(Average of daily measurements for 2-4 weeks using the investigational foot (B) and 2-4 weeks using the usual foot (A2). Outcome is B- A2.)
- Difference Between Investigational Foot and Usual Foot in the Comprehensive Lower Extremity Amputee Socket Survey (CLASS): Stability Subscale(Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.)
- Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Sound Subscale(Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.)
- Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Utility Subscale(Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.)
Investigators
Murray Maitland
Associate Professor, School of Medicine, Rehabilitation Medicine
University of Washington