Rehabilitating Corticospinal Control of Walking
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/13/2019 |
| Start Date: | June 2, 2014 |
| End Date: | May 31, 2019 |
Rehabilitation of Corticospinal Control of Walking Following Stroke
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.
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.
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.
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.
Inclusion Criteria:
- occurrence of a single unilateral stroke within the previous 6-18 months (verified by
MRI or CT from medical record)
- living in the community and able to travel to training and assessment sites
- approval of participation by primary care physician
- age 18 - 80 years
- lower extremity paresis indicated by Fugl-Meyer Assessment Score < 30
- deficit in at least one "synergy" subcategory (II - IV) of the Fugl-Meyer Assessment
- self-selected 10m gait speed of 0.4 - 0.8 m/s (with or without an ankle/foot orthosis
or cane)
- able to provide informed consent
- willingness to be randomized to either intervention group
- written approval by primary care physician
Exclusion Criteria:
neurological disorder or injury (other than stroke) such as Parkinson' s disease or spinal
cord injury
- severe arthritis, such as awaiting joint replacement, that would interfere with study
participation
- cardiovascular disease (congestive heart failure, significant valvular disease,
history of cardiac arrest, presence of an implantable defibrillator, uncontrolled
angina)
- myocardial infarction or major heart surgery in the previous year
- cancer requiring treatment in the past three years, except for nonmelanoma skin
cancers and other cancers having an excellent prognosis (e.g., early stage breast or
prostate cancer)
- lung disease requiring use of corticosteroids or supplemental oxygen
- renal disease requiring dialysis
- current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- Mini-Mental State Examination (MMSE) score <23
- major depression (Patient Health Questionnaire score > 10)
- severe obesity (body mass index > 35)
- uncontrolled hypertension (systolic > 200 mmHg and/or diastolic > 110 mmHg)
- uncontrolled diabetes with recent diabetic coma or frequent hypoglycemia
- bone fracture or joint replacement in the previous six months
- diagnosis of a terminal illness
- current participation in physical therapy or cardiopulmonary rehabilitation
- significant visual impairment affecting capability to gauge movement accuracy
- previous enrollment in a clinical trial for recovery of walking function
- current enrollment in any clinical trial
- planning to relocate out of the greater Gainesville FL area during the study period
- unable to communicate sufficiently with study personnel
- clinical judgment regarding safety or noncompliance
We found this trial at
2
sites
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Gainesville, Florida 32608
Principal Investigator: David J. Clark, DSc
Phone: 352-376-1611
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