Traumatic Amputation of Lower Extremity Clinical Trial
Official title:
A Comparison of External Mechanical Work Between Bionic and Conventional Prosthetic Feet in Transtibial Amputees During Functional Activities
Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are
at risk of functional decline, joint degeneration, skin breakdown and further limb loss due
to the forces placed on the contralateral limb through prosthetic ambulation. If specialized
prosthetic gait training and proper use of the appropriate prosthetic foot can decrease
forces on the intact limb, the long term health and quality of life of veterans with
amputations could be substantially improved. We will address two key questions:
Key Question 1: After receiving specialized gait training and a new prosthetic socket, will
subjects demonstrate differences in gait symmetry and external mechanical work between the
bionic and conventional prosthetic feet, while performing various functional activities.
Key Question 2: Can external mechanical work be used as a clinically friendly measure to
differentiate between prosthetic feet?
The study examined the application of outcome measures to determine changes in function of unilateral transtibial amputees (TTAs) caused by specialized functional prosthetic training (training) and the use of four different prosthetic feet. Two self-report measures i.e. the Prosthetic Evaluation Questionnaire (PEQ-13) and Locomotor Capability Index (LCI-5), and three performance-based measures i.e. the Amputee Mobility Predictor (AMPPRO), Six-minute Walk Test (6MWT), and Step Activity Monitor (SAM) were utilized. Healthy unilateral Transtibial Amputees between the age of 40-65 will participate in the study. Subjects were tested at baseline, after receiving training with their existing prosthesis, and with the study socket and four prosthetic feet i.e. SACH, SAFE, Talux and PROPRIO FOOT over an 8-10 week period. Training was administered between testing sessions. ;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02931396 -
Functional Electrical Stimulation Use in Trans-tibial Amputations
|
N/A | |
| Completed |
NCT02318979 -
What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
|
N/A | |
| Completed |
NCT05597696 -
Sitting Balance in Lower Limb Amputees
|
||
| Completed |
NCT00869947 -
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
|
N/A | |
| Completed |
NCT03027947 -
Spinal Root and Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees
|
N/A | |
| Completed |
NCT01784003 -
Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development
|
||
| Completed |
NCT01419288 -
Treadmill Training With Lower Extremity Amputees
|
Phase 1 | |
| Completed |
NCT04486534 -
The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation
|
||
| Completed |
NCT02540681 -
Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma
|
||
| Completed |
NCT02491424 -
Intraosseous Transcutaneous Amputation Prosthesis
|
N/A | |
| Recruiting |
NCT04547582 -
Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day
|
N/A | |
| Recruiting |
NCT05929508 -
Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss
|
N/A |