Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Socket Designs of Transfemoral Amputees.
- Sponsor
- University of South Florida
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Socket Pressure
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of care using our designated outcome measures.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Unilateral transfemoral or knee-disarticulation amputee
- •18 to 85 years of age
- •K3 (variable cadence and community) ambulators;
- •Be able to independently provide informed consent
- •Be willing to comply with study procedures.
Exclusion Criteria
- •History of chronic skin breakdown on the residual limb
- •Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
- •Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
- •Unwillingness/inability to follow instructions
Outcomes
Primary Outcomes
Socket Pressure
Time Frame: 10 minutes after fitting with both sockets
Pressure sensors are placed on the skin and measured.
Balance and Stability
Time Frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Balance and stability will be assessed for limits of stability and postural stability.
Quality of Life
Time Frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Validated surveys will be used to solicit participants' subjective experience and feedback.
Gait
Time Frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Gait will be assessed in terms of biomechanics and spatiotemporal parameters.