Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee
- Conditions
- Amputation
- Interventions
- Device: Dynamic Socket Ischial Ramus Containment (IRC)Device: Ischial Ramus Containment (IRC)Device: Sub-Ischial Interface (Sub-I)
- Registration Number
- NCT02773056
- Lead Sponsor
- University of South Florida
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Socket 2 (Dynamic Socket IRC) Dynamic Socket Ischial Ramus Containment (IRC) This arm included unilateral transfemoral amputees who were assessed while using the Dynamic Socket Ischial Ramus Containment socket. Socket 1 (Ischial Ramus Containment) Ischial Ramus Containment (IRC) This arm included unilateral transfemoral amputees who were assessed while using the Ischial Ramus Containment socket. Socket 3 (Sub-Ischial Interface) Sub-Ischial Interface (Sub-I) This arm included unilateral transfemoral amputees who were assessed while using the Sub-Ischial Interface socket.
- Primary Outcome Measures
Name Time Method Skin Temperature 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 Accommodation with new prosthetic sockets is approximately 10 days Perspiration will be measured by tare weight (grams) following treadmill walking.
Vertical Interface Movement (Pistoning) 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 Outcome Measures
Name Time Method Balance and Stability Accommodation with new prosthetic sockets is approximately 10 days The gold standard test of standing balance is the sensory organization test (SOT) administered on the Neurocom Equitest platform. The SOT score is a unitless number. Subjects stand on a pair of platforms that record force data and tilt in the sagittal plane during 6 varying conditions that challenge the visual, vestibular and somatosensory systems. With compromised ability to use an ankle strategy for balance, a hip strategy is routinely adopted, therefore higher interface trim lines could adversely affect performance on this test.
Comfort Accommodation with new prosthetic sockets is approximately 10 days The Socket Comfort Score (rated on an 11-point 0-10 scale) will be used to assess patients' comfort in the respective sockets.
Preference Accommodation with new prosthetic sockets is approximately 10 days Patients will be asked which socket they preferred.
Trial Locations
- Locations (1)
University of South Florida
🇺🇸Tampa, Florida, United States