Clinical trial NCT02892084: Augmentation of Locomotor Adaptation Post-Stroke
Official title: Augmentation of Locomotor Adaptation Post-Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Keywords: Chronic Stroke ( > 6 months)
non-invasive brain stimulation
rehabilitation
walking
kinetics
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Ralph H. Johnson VA Medical Center
First posted: 2016-09-08
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Center of Mass Acceleration Peak
timeFrame: Pre (same as initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
Secondary outcomes:
measure: Center of Mass Acceleration Impulse
timeFrame: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
Other outcomes:
measure: Self-selected walking speed
timeFrame: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
measure: Paretic step ratio
timeFrame: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
Locations:
city: Charleston
country: United States
facility: MUSC Center for Rehabilitation Research in Neurologic Conditions
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center
name: Mark G Bowden, PhD, PTf
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bowden MG, Balasubramanian CK, Neptune RR, Kautz SA. Anterior-posterior ground reaction forces as a measure of paretic leg contribution in hemiparetic walking. Stroke. 2006 Mar;37(3):872-6. doi: 10.1161/01.STR.0000204063.75779.8d. Epub 2006 Feb 2.
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