Rehabilitating Corticospinal Control of Walking (ABC of Walking)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Collaborators:
University of Florida
Brooks Center for Rehabilitation Studies
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02132650
First received: April 23, 2014
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Behavioral: ACC training
Behavioral: SS training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rehabilitation of Corticospinal Control of Walking Following Stroke

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in Walking Speed [ Time Frame: assessed pre-intervention (0 months), post-intervention (3 months) and follow up (six months) ] [ Designated as safety issue: No ]
    self selected (preferred) steady state walking speed


Secondary Outcome Measures:
  • Change in Intermuscular Coordination [ Time Frame: assessed pre-intervention (0 months), post-intervention (3 months) and follow up (six months) ] [ Designated as safety issue: No ]
    Timing of electromyography from leg muscles

  • Change in Synchrony of EMG in Piper frequency band [ Time Frame: assessed pre-intervention (0 months), post-intervention (3 months) and follow up (six months) ] [ Designated as safety issue: No ]
    EMG frequency analysis to determine if EMG signal content is consistent with recovery of corticospinal drive


Estimated Enrollment: 60
Study Start Date: June 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACC
Rehabiliation of walking using accurate (ACC) walking tasks
Behavioral: ACC training
Rehabiliation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc.
Active Comparator: SS
Rehabilitation of walking using typical steady state (SS) walking
Behavioral: SS training
Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02132650

Contacts
Contact: David J Clark, DSc (352) 376-1611 ext 5244 David.Clark1@va.gov
Contact: Helen M Emery, BS BA (352) 376-1611 ext 5855 hemery@phhp.ufl.edu

Locations
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Janis Daly, PhD MS    352-376-1611 ext 6603    Janis.Daly@va.gov   
Contact: Stephen E Nadeau, MD BS BS    (352) 374-6114    Stephen.Nadeau@va.gov   
Principal Investigator: David J. Clark, DSc         
Sponsors and Collaborators
University of Florida
Brooks Center for Rehabilitation Studies
Investigators
Principal Investigator: David J. Clark, DSc North Florida/South Georgia Veterans Health System, Gainesville, FL
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02132650     History of Changes
Other Study ID Numbers: B1149-R
Study First Received: April 23, 2014
Last Updated: May 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Rehabilitation
Walking
Motor skills disorders
Electromyography

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 01, 2014