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CompletedNCT02132650ABC of WalkingUpdated May 5, 2022Results posted

Rehabilitating Corticospinal Control of Walking

An interventional study of ACC training and SS training in Stroke, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • Rehabilitation
  • Walking
  • Motor skills disorders
  • Electromyography
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 38 is below the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    ACC

    Rehabilitation of walking using accurate (ACC) walking tasks

    Behavioral: ACC training

  • Active comparator
    SS

    Rehabilitation of walking using typical steady state (SS) walking

    Behavioral: SS training

Interventions

  • BehavioralACC training

    Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc.

  • BehavioralSS 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.

06

What researchers measure

Primary outcomes

  1. Change in Walk Speed From Pre-Intervention (0 Months) to Post-Intervention (3 Months)

    self selected (preferred) steady state walking speed

    Time frame: assessed pre-intervention (0 months) and post-intervention (3 months)

  2. Change in Walk Speed From Pre-Intervention (0 Months) to Follow-Up (6 Months)

    self selected (preferred) steady state walking speed

    Time frame: assessed pre-intervention (0 months) and follow-up (6 months)

07

Results

Posted Jun 9, 2020

Participant flow

Participant flow — Overall Study
MilestoneAccurate Walking TrainingSteady State Walking Training
Started2018
Post-intervention assessment1917
Completed1714
Not completed34

Outcome measures

PrimaryChange in Walk Speed From Pre-Intervention (0 Months) to Post-Intervention (3 Months)

self selected (preferred) steady state walking speed

Time frame:
assessed pre-intervention (0 months) and post-intervention (3 months)
Reported as:
Mean · meters per second
Change in Walk Speed From Pre-Intervention (0 Months) to Post-Intervention (3 Months)
meters per secondAccurate Walking TrainingSteady State Walking Training
Change in Walk Speed From Pre-Intervention (0 Months) to Post-Intervention (3 Months)0.13 ± 0.110.14 ± 0.13
PrimaryChange in Walk Speed From Pre-Intervention (0 Months) to Follow-Up (6 Months)

self selected (preferred) steady state walking speed

Time frame:
assessed pre-intervention (0 months) and follow-up (6 months)
Reported as:
Mean · meters per second
Change in Walk Speed From Pre-Intervention (0 Months) to Follow-Up (6 Months)
meters per secondAccurate Walking TrainingSteady State Walking Training
Change in Walk Speed From Pre-Intervention (0 Months) to Follow-Up (6 Months)0.10 ± 0.120.07 ± 0.11

Adverse events

Collected over Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Accurate Walking Training0/20 (0%)1/20 (5%)5/20 (25%)
Steady State Walking Training0/18 (0%)1/18 (5.6%)6/18 (33.3%)
Most frequent serious events
Most frequent serious events
EventAccurate Walking TrainingSteady State Walking Training
unstable medical conditionGeneral disorders0/201/18
painNervous system disorders1/200/18
Most frequent other events
Most frequent other events
EventAccurate Walking TrainingSteady State Walking Training
fallingGeneral disorders2/205/18
bone fracture occurring offsiteMusculoskeletal and connective tissue disorders2/200/18
seizureNervous system disorders0/201/18
car accidentGeneral disorders1/200/18

Baseline characteristics

Age, Continuous
Age, Continuous(years)Accurate Walking TrainingSteady State Walking TrainingTotal
Mean60.5 ± 9.958.6 ± 8.459.6 ± 9.14
Sex: Female, Male
Sex: Female, Male(Participants)Accurate Walking TrainingSteady State Walking TrainingTotal
Female8715
Male121123
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Accurate Walking TrainingSteady State Walking TrainingTotal
American Indian or Alaska Native101
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American7512
White121224
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Accurate Walking TrainingSteady State Walking TrainingTotal
United States201838
Time since stroke
Time since stroke(months)Accurate Walking TrainingSteady State Walking TrainingTotal
Mean15.4 ± 10.020.9 ± 10.518.0 ± 10.5
08

Study locations

2 sites
  • North Florida/South Georgia Veterans Health System, Gainesville, FL
    Gainesville, Florida 32608, United States
  • Brooks Rehabilitation Hospital
    Jacksonville, Florida 32216, United States
09

References and documents

Publications

  • Clark DJ, Rose DK, Butera KA, Hoisington B, DeMark L, Chatterjee SA, Hawkins KA, Otzel DM, Skinner JW, Christou EA, Wu SS, Fox EJ. Rehabilitation with accurate adaptability walking tasks or steady state walking: A randomized clinical trial in adults post-stroke. Clin Rehabil. 2021 Aug;35(8):1196-1206. doi: 10.1177/02692155211001682. Epub 2021 Mar 16. PubMed 33722075 ↗
  • Chatterjee SA, Daly JJ, Porges EC, Fox EJ, Rose DK, McGuirk TE, Otzel DM, Butera KA, Clark DJ. Mobility Function and Recovery After Stroke: Preliminary Insights From Sympathetic Nervous System Activity. J Neurol Phys Ther. 2018 Oct;42(4):224-232. doi: 10.1097/NPT.0000000000000238. PubMed 30138228 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 16, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02132650
Lead sponsor
VA Office of Research and Development
Collaborators
University of Florida, Brooks Rehabilitation
Responsible party
Sponsor
First posted
May 7, 2014
Start date
Jun 2, 2014
Primary completion
May 31, 2019
Completion
May 31, 2019
Results posted
Jun 9, 2020
Last update
May 5, 2022

Study contacts

David J. Clark, DSc
principal investigator · North Florida/South Georgia Veterans Health System, Gainesville, FL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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