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Augmentation of Locomotor Adaptation Post-Stroke

Augmentation of Locomotor Adaptation Post-Stroke

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02892084
Enrollment
29
Registered
2016-09-08
Start date
2013-04-30
Completion date
2018-03-31
Last updated
2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Chronic Stroke ( > 6 months), non-invasive brain stimulation, rehabilitation, walking, kinetics

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.

Interventions

DEVICEtDCS

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.

DEVICESham 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.

Sponsors

Ralph H. Johnson VA Medical Center
CollaboratorFED
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Center of Mass Acceleration PeakPre (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

MeasureTime frameDescription
Center of Mass Acceleration ImpulsePre (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

MeasureTime frameDescription
Self-selected walking speedPre (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.
Paretic step ratioPre (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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026