NCT04477330 · University of Illinois at Chicago
Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal
What this study is about
Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation.
View original scientific description
Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation. This project focuses on the development of a long term gait rehabilitation protocol using brain stimulation to improve walking outcomes in people with stroke. The project will also aim to understand the neural mechanisms that are associated with response to the intervention.
Interventions
OTHER
Transcranial direct current stimulation (tDCS)
1 mA tDCS
OTHER
Ankle motor training
Visuomotor target tracking task
BEHAVIORAL
High intensity interval speed based treadmill training (HIISTT)
Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.
Primary outcome measures
Walking speed with 10 meter walk test
Time frame: Change from baseline to immediately after training and baseline to 3 months follow up
Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-m walk test (10MWT).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age greater than 18 years
- First ever monohemispheric stroke \> 3 months since onset
- Residual hemiparetic gait deficits (e.g. abnormal gait pattern)
- Able to walk for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
- Walking speed lesser than 1.2 m/s
- Lower limb Fugl-Meyer Motor score between 15-30
- At least 5 deg of ankle dorsiflexion necessary to perform the ankle-tracking task
Exclusion criteria
- General exclusion criteria
- Severe osteoporosis
- Contracture-limiting range of motion of lower limb
- Score of more than 2 on the Modified Ashworth Scale (indicating increased muscle tone through ankle range of motion)
- Uncontrolled anti-spasticity medications during the study period
- Score less than 6 on the Fugl-Meyer Sensory Assessment Scale for the Lower Limb
- Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
- Unhealed decubiti, persistent infection
- Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)\<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task.
- Lesions involving the brainstem and cerebellum
- Failure to pass the graded exercise stress test TMS exclusion criteria
- Implanted cardiac pacemaker
- Metal implants in the head or face
- Unexplained, recurring headaches
- History of seizures or epilepsy
- Currently under medication that could increase motor excitability and lower seizure threshold
- Skull abnormalities or fractures
- Concussion within the last 6 months
- Currently pregnant tDCS exclusion criteria
- Skin hypersensitivity
- History of contact dermatitits
- History of allodynia and/or hyperalgesia
- Any other skin or scalp condition that could be aggravated by tDCS
Where
- Chicago, Illinois
Collaborators
University of Maryland, College Park, Northwestern University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations