Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02132650 |
| Other study ID # |
B1149-R |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2, 2014 |
| Est. completion date |
May 31, 2019 |
Study information
| Verified date |
April 2022 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The VHA estimates that over 15,000 Veterans incur a stroke each year. As the population of
older Veterans grows, stroke will become an increasingly important problem to the VHA.
Recovery of walking function is the most common goal of stroke survivors. The proposed study
will test whether training with accurate walking tasks to engage the damaged supraspinal
motor pathways is more effective than training with steady state walking. The investigators
expect that training accurate tasks will be more effective, thereby improving walking
function of Veteran stroke survivors and reducing the burden of care placed on families and
on the VHA. Furthermore, this rehabilitation approach can be accomplished at comparable cost
to existing rehabilitation approaches, which is important given that the VHA invests $88
million per year toward outpatient care, including physical rehabilitation, in the first six
months after stroke. This research also has implications for rehabilitation of other
neurologically injured populations, including traumatic brain injury and incomplete spinal
cord injury.
Description:
Current approaches for rehabilitation of walking following stroke do not sufficiently restore
mobility function. For instance, fewer than 50% of individuals with stroke-induced walking
dysfunction recover the ability to walk independently in the community. New breakthroughs in
rehabilitation are needed that will target the motor impairments responsible for poor walking
function in individuals post-stroke. Functional recovery can occur in response to
task-specific neuroplasticity of damaged brain circuitry. The corticospinal tract is an
important target for neuroplasticity because it plays an important role for control of
walking in humans. Research has shown that, compared to steady state walking, accurate gait
modification (ACC) tasks are a potent behavioral stimulus for activating the corticospinal
tract. Therefore, the investigators propose that training with ACC tasks (e.g., obstacle
crossing/avoidance, accurate foot placement, etc.) may be superior to training with steady
state walking (SS) for eliciting corticospinal neuroplasticity and recovery of walking
function. Most rehabilitation paradigms have previously focused on SS training. This is
largely because therapists consider it premature to progress to ACC tasks when persistent
deficits of steady state walking still remain. However, this reasoning might be
counter-productive, because training only steady state walking may not sufficiently stimulate
neuro-plasticity of the damaged corticospinal pathway. In contrast, ACC training is
specifically designed to stimulate corticospinal neuroplasticity. Importantly, since ACC
training targets a central mechanism, its benefits are expected to generalize across walking
conditions. Furthermore, it is expected to benefit most stroke survivors who possess at least
a minimal residual capability to activate the corticospinal tract. ACC training also provides
an opportunity to practice tasks that are analogous to challenges encountered in the home and
community environments. Accordingly, there is strong mechanistic and practical rationale for
ACC training.
A number of earlier studies have cumulatively established exciting preliminary evidence
showing that walking function is enhanced by training with ACC tasks. However, no prior study
has been specifically designed and sufficiently powered to determine the extent to which the
"accurate gait modification" ingredient is crucial for recovery of walking function. Also not
known is the extent to which ACC training reduces the neural impairments underlying poor
walking function. The central hypothesis of this study is that ACC training will be superior
to SS training for increasing walking function and for reducing underlying neural control of
the paretic leg in adults with post-stroke hemiparesis. Each intervention will involve twelve
weeks of training, 3 days per week (36 sessions total), and will emphasize the motor learning
principles of high intensity, repetition and task-specificity. Assessments will be conducted
immediately pre-intervention, immediately post-intervention and at a follow-up session 3
months later. Walking function will be measured in the lab and in the "real world". Neural
impairment measures will include electromyography-based measures of inter-muscular
coordination and corticospinal drive.
The investigators expect that the benefits of ACC training will justify larger randomized
controlled trials to optimize the use of ACC training, including timing relative to stroke,
combination with other therapeutic approaches, and identifying individuals who are most
likely to benefit from this approach. This research is expected to enhance walking function
in stroke survivors, including for the 15,000 Veterans who suffer a stroke each year.
