Amputation
Conditions
Keywords
transfemoral, amputation, perspiration, socket, socket comfort
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.
Interventions
DEVICEIschial Ramus Containment (IRC)
Ischial Ramus Containment (IRC) is the standard of care socket
DEVICEDynamic Socket Ischial Ramus Containment (IRC)
Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket
DEVICESub-Ischial Interface (Sub-I)
Sub-Ischial Interface (Sub-I) is a comparator study socket
Sponsors
United States Department of Defense
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed