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Augmentation of Locomotor Adaptation Post-Stroke

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ClinicalTrials.gov Identifier: NCT02892084
Recruitment Status : Unknown
Verified April 2016 by Medical University of South Carolina.
Recruitment status was:  Recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Collaborator:
Ralph H. Johnson VA Medical Center
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Device: tDCS Device: Sham tDCS Phase 1

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Augmentation of Locomotor Adaptation Post-Stroke
Study Start Date : April 2013
Estimated Primary Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892084


Contacts
Contact: Brian Cence 843-792-2668 cence@musc.edu
Contact: Eric D Monsch, DPT, PT monsch@musc.edu

Locations
United States, South Carolina
MUSC Center for Rehabilitation Research in Neurologic Conditions Recruiting
Charleston, South Carolina, United States, 29425
Contact: Brian Cence    843-792-2668    cence@musc.edu   
Contact: Eric D Monsch, DPT, PT       monsch@musc.edu   
Principal Investigator: Mark D Bowden, PhD, PT         
Sponsors and Collaborators
Medical University of South Carolina
Ralph H. Johnson VA Medical Center
Investigators
Principal Investigator: Mark G Bowden, PhD, PTf Ralph H. Johnson VA Medical Center

Publications:

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02892084     History of Changes
Other Study ID Numbers: 16060
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Medical University of South Carolina:
Chronic Stroke ( > 6 months)
non-invasive brain stimulation
rehabilitation
walking
kinetics

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