Back to resultsAugmentation of Locomotor Adaptation Post-Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Chronic Stroke ( > 6 months), non-invasive brain stimulation, rehabilitation, walking, kinetics
Eligibility Criteria
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.
Sites / Locations
- MUSC Center for Rehabilitation Research in Neurologic Conditions
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Uphill COMa training
Downhill COMa training
Arm Description
Walking on an inclined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.
Walking on a declined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.
Outcomes
Primary Outcome Measures
Center of Mass Acceleration Peak
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
Center of Mass Acceleration Impulse
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).
Full Information
NCT ID
NCT02892084
First Posted
May 3, 2016
Last Updated
June 26, 2018
Sponsor
Medical University of South Carolina
Collaborators
Ralph H. Johnson VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02892084
Brief Title
Augmentation of Locomotor Adaptation Post-Stroke
Official Title
Augmentation of Locomotor Adaptation Post-Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Ralph H. Johnson VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Chronic Stroke ( > 6 months), non-invasive brain stimulation, rehabilitation, walking, kinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Uphill COMa training
Arm Type
Experimental
Arm Description
Walking on an inclined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.
Arm Title
Downhill COMa training
Arm Type
Experimental
Arm Description
Walking on a declined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
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 Measure Information:
Title
Center of Mass Acceleration Peak
Description
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.
Time Frame
Pre (same as initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
Secondary Outcome Measure Information:
Title
Center of Mass Acceleration Impulse
Description
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).
Time Frame
Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
Other Pre-specified Outcome Measures:
Title
Self-selected walking speed
Description
Walking speed overground for 10 meters, average of 3 timed trials, expressed as m/sec.
Time Frame
Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
Title
Paretic step ratio
Description
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.
Time Frame
Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark G Bowden, PhD, PTf
Organizational Affiliation
Ralph H. Johnson VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUSC Center for Rehabilitation Research in Neurologic Conditions
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
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Augmentation of Locomotor Adaptation Post-Stroke
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