Augmentation of Locomotor Adaptation Post-Stroke

June 26, 2018 updated by: Medical University of South Carolina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Center for Rehabilitation Research in Neurologic Conditions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: Chronic Stroke

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

Exclusion Criteria: Acute Stroke

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Uphill COMa training
Walking on an inclined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.
Device: tDCS
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.
Device: Sham tDCS
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.
Experimental: Downhill COMa training
Walking on a declined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.
Device: tDCS
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.
Device: Sham tDCS
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

Ralph H. Johnson VA Medical Center

Investigators

  • Principal Investigator: Mark G Bowden, PhD, PTf, Ralph H. Johnson VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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