Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- University of South Florida
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Skin Temperature
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Unilateral above the knee amputees of non-dysvascular etiology
- •100-275 lbs
- •≥ 1 yr. of prosthetic experience
- •Independent community ambulator
- •Self-reported ability to walk for 20min consecutively
Exclusion Criteria
- •Above the knee amputees of dysvascular etiologies
- •Body weight \<100 or \>275 lbs
- •Does not speak English or Spanish
- •Use of an assistive device (i.e. canes, walkers)
- •Transtibial, hip disarticulation, hemipelvectomy, partial foot and bilateral amputees
- •Known skin issues
- •Known cognitive impairment
Outcomes
Primary Outcomes
Skin Temperature
Time Frame: Accommodation with new prosthetic sockets is approximately 10 days
Continuous skin temperature measurement (Celsius) will be taken during treadmill walking at self-selected comfortable speed
Perspiration
Time Frame: Accommodation with new prosthetic sockets is approximately 10 days
Perspiration will be measured by tare weight (grams) following treadmill walking.
Vertical Interface Movement (Pistoning)
Time Frame: Accommodation with new prosthetic sockets is approximately 10 days
Pistoning will be defined as the numerical difference of interface to skeletal movement (cm) between simulated swing (lifting the prosthetic side) and stance (single support on the prosthetic side) as measured by coronal X-Ray.
Secondary Outcomes
- Balance and Stability(Accommodation with new prosthetic sockets is approximately 10 days)
- Comfort(Accommodation with new prosthetic sockets is approximately 10 days)
- Preference(Accommodation with new prosthetic sockets is approximately 10 days)