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Completed

NCT Number: NCT02892084

Augmentation of Locomotor Adaptation Post-Stroke

This project will evaluate two different methods of normalizing the center of mass acceleration (COMa) in individuals post-stroke, specifically focusing on rates and pattern of recovery to analyze walking-specific adaptations as precursors to motor learning. In addition, the proposed project seeks to establish the optimal configuration of electrodes to activate neural circuits involved in post-stroke locomotion. Once the better method of training COMa and optimal parameters of electrode placement for tDCS are identified, the investigators will evaluate the effects of tDCS on locomotor adaptations during single sessions and over a five-day training period.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MUSC Center for Rehabilitation Research in Neurologic Conditions

Charleston, South Carolina, 29425, United States

About this study

The project seeks to establish the optimal configuration of electrodes to change the excitability of neural circuits involved in post-stroke locomotion, identify effective strategies for training a specific locomotor adaptation, and improve adaptations via adjunctive non-invasive brain stimulation. Tools to improve neural excitability may increase potential for locomotor skill learning, thereby improving rehabilitation outcomes. Non-invasive brain stimulation with transcranial direct current stimulation (tDCS) has recently emerged as a simple to administer, low-cost, and low-risk option for stimulating brain tissue. Cortical excitability is increased after application and preliminary results imply a relationship to increases in motor activity in those post-stroke. However, inhibition of the contralesional hemisphere is also shown to improve paretic motor output through inhibition of excessive maladaptive strategies, and combining the two electrode configurations may provide additional benefit for locomotor tasks requiring interlimb coordination. Furthermore, the effects of tDCS on walking function in conjunction with physical intervention strategies aimed at improving locomotor ability post-stroke are yet unstudied.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chronic Stroke

  • age 18-70
  • at least six month post-stroke
  • residual paresis in the lower extremity (Fugl-Meyer LE motor score <34)
  • ability to sit unsupported for ≥ 30 sec
  • ability to walk at least 10 ft.
  • self-selected 10 meter gait speed < 0.8 m/s
  • provision of informed consent.

Exclusion criteria

Acute Stroke

  • Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking < 200 meters
  • history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
  • History of COPD or oxygen dependence
  • Preexisting neurological disorders, dementia or previous stroke
  • History of major head trauma
  • Legal blindness or severe visual impairment
  • history of significant psychiatric illness
  • Life expectancy <1 yr
  • Severe arthritis or orthopedic problems that limit passive ROM
  • post-stroke depression (PHQ-9 ≥10)
  • History of DVT or pulmonary embolism within 6 months
  • Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  • Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest
  • presence of cerebellar stroke.

Treatment and study plan

tDCS

Device

Constant non-invasive, low intensity, direct electrical current utilized to stimulate specific areas of the brain. Evaluating immediate effects of anodal/cathodal stimulation during 20 minutes of treadmill walking.

Sham tDCS

Device

Per published protocols, tDCS will be administered for 30 secs allowing for sensory adaptation to occur and then turned off, so that the remaining sham "stimulation" will include zero current. Evaluating immediate effects during 20 minutes walking on a treadmill.

Primary outcomes

  1. Center of Mass Acceleration Peak

    Time frame: Pre (same as initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.

    Peak full body center of mass acceleration during gait, expressed as m/sec^2, captured during 30 seconds of treadmill walking at a steady-state, self-selected walking speed.

Secondary outcomes

  1. Center of Mass Acceleration Impulse

    Time frame: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.

    Positive integral of the full body center of mass acceleration during the gait cycle, expressed as an average over all strides captured during 30 seconds of data collection at a steady-state, self-selected walking speed (m/sec).

Other outcomes

  1. Self-selected walking speed

    Time frame: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.

    Walking speed overground for 10 meters, average of 3 timed trials, expressed as m/sec.

  2. Paretic step ratio

    Time frame: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.

    Percentage of the total stride completed by paretic step. This is a unit-less measure. Each stride is initiated by foot strike of the paretic leg, and the data are expressed as an average over all strides captured during 30 seconds of data collection at a steady-state, self-selected walking speed.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Ralph H. Johnson VA Medical Center

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 8, 2016
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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