Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03974945 |
| Other study ID # |
A2943-R |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
May 14, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
VA Office of Research and Development |
| Contact |
Alena Grabowski, PhD BA |
| Phone |
(720) 435-4270 |
| Email |
Alena.Grabowski[@]va.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Previous studies suggest that Veterans with below the knee amputation using passive-elastic
or powered prostheses have impaired physical function, which could increase the risk of
osteoarthritis, leg/back pain, and diabetes/obesity. Utilization of rehabilitation
strategies/techniques such as real-time visual feedback training could restore physical
function, increase physical activity, and reduce injury risk. The investigators will
systematically determine the effects of using real-time visual feedback training of peak
propulsive (push-off) force during walking while Veterans with below the knee amputations use
a passive-elastic and battery-powered prosthesis. Similar to previous studies of non-amputee
older (>65 years) and post-stroke adults, use of real-time visual feedback training of
propulsive force will likely improve walking function in Veterans with amputations. Such
training presents a promising rehabilitation strategy that could reduce comorbidities, while
improving quality of life, comfort, and physical function, and advancing rehabilitation
research and prosthetic development.
Description:
Due to the functional impairments caused by a lower limb amputation, it is essential to
determine the benefits of rehabilitation strategies such as real-time visual feedback
training. Such training could allow Veterans with transtibial amputations (TTAs) to better
utilize their prostheses and regain the greatest possible level of function. It is not clear
how much the prosthetic device (passive-elastic prosthetic foot versus battery-powered
ankle-foot prosthesis) and/or the user's response to the prosthesis contribute to the
biomechanical and metabolic effects of using these prostheses during walking. Better use of a
prosthesis due to targeted real-time visual feedback training could enhance rehabilitation,
improve function and reduce asymmetric biomechanics, which in turn could reduce common
comorbidities such as osteoarthritis, leg and back pain, and indirectly, diabetes in Veterans
with TTAs. The purpose of the proposed project is to systematically establish the metabolic
and biomechanical effects of targeted real-time visual feedback training of peak propulsive
ground reaction force (GRF) on the biomechanics, metabolic costs, and muscle activity of
Veterans with TTAs using their own passive-elastic prosthetic foot and a battery-powered
ankle-foot prosthesis. The results of the investigators' research could enhance the use of
prosthetic technology to improve the rehabilitation and function of Veterans with lower limb
amputations.
Previous studies suggest that use of passive-elastic and/or powered ankle-foot prostheses may
not optimize the function of Veterans with TTAs during walking. Targeted, real-time visual
feedback training of peak propulsive ground reaction forces increased propulsion and improved
walking function in older (>65 years) and post-stroke adults, who typically have impaired
ankle power. To the investigators' knowledge, no research has addressed how visual feedback
of peak propulsive force affects the use of passive-elastic or powered ankle-foot prostheses
by people with TTAs. In the proposed research, the investigators will determine the
underlying metabolic costs, biomechanics, stability, and muscle activity resulting from
targeted real-time visual feedback training of peak propulsive force to identify how Veterans
with a TTA benefit from more effective use of a passive-elastic prosthesis and/or a
battery-powered ankle-foot prosthesis and to determine if the addition of mechanical power
provided by a battery-powered ankle-foot prosthesis can further enhance the function of
Veterans with unilateral TTAs during walking. 30 Veterans with unilateral TTAs will use their
own passive-elastic prosthesis both with and without visual feedback training during
level-ground walking, while the investigators measure their metabolic costs and biomechanics.
Then, they will use a powered ankle-foot prosthesis (emPOWER, BiONX, Ottobock) both with and
without visual feedback training during level-ground walking, while the investigators measure
their metabolic costs and biomechanics. With each prosthesis, subjects will walk at 1.25 m/s
on a dual-belt force-measuring treadmill 1) with no visual feedback, and then with real-time
visual feedback of: 2) peak propulsive force from the "no feedback" condition, 3) +20%
greater peak propulsive force, and 4) +40% greater peak propulsive force. During these visual
feedback trials, the investigators will ask subjects to match the peak propulsive force
displayed on a computer screen with their affected leg. The investigators will also ask
subjects to: 5) match symmetric visual feedback of the peak propulsive force from both legs.
The investigators will determine if Veterans with TTAs utilizing real-time visual feedback
training of peak propulsive force can improve metabolic costs, biomechanical symmetry, and
dynamic stability/balance, while using their own passive-elastic prosthesis or a powered
ankle-foot prosthesis. The investigators will also establish if Veterans with TTAs can retain
the metabolic and biomechanical benefits elicited by real-time visual feedback training once
that feedback is removed. Results from the proposed project will be used to inform
rehabilitation strategies and prosthetic design, which could ultimately improve health,
maximize function, and improve quality of life for Veterans with TTAs.
