A Phase 2 interventional study of Cerebello-spinal direct current stimulation and Sham Comparator in Stroke Rehabilitation, Gait Disorders, Neurologic and tDCS, sponsored by Universidade Federal de Pernambuco. Recruiting at 3 sites in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Universidade Federal de Pernambuco · Phase 2, Interventional, and Treatment
The aim of this clinical trial is to determine if cerebello-spinal direct current stimulation (csDCS) is effective in treating gait disorders in individuals with chronic stroke. Additionally, the trial seeks to evaluate the safety of this technique.
The primary objectives include:
Investigating whether cerebello-spinal direct current stimulation improves gait and functional mobility in participants with chronic stroke.
Assessing any potential side effects associated with the method.
Researchers will conduct a comparative analysis between cerebello-spinal direct current stimulation and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness in addressing gait disorders and enhancing mobility.
Participants in the trial will:
Undergo cerebello-spinal direct current stimulation combined with treadmill training or a sham procedure with treadmill training daily over a two-week period.
327 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 246 interventional studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →Universidade Federal de Pernambuco is the lead sponsor of 161 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes.
Device: Cerebello-spinal direct current stimulation
Treadmill training with masking for cerebello-spinal direct current stimulation
Device: Sham Comparator
csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes.
Also known as: csDCS
Masking for cerebello-spinal direct current stimulation involves the electric current stopping after 30 seconds, providing a sensation without producing neuromodulation.
Functional Mobility
The Timed-Up and Go (TUG) test is used to evaluate an individual´s capacity to stand up, walk, and sit down. During the test, the participants are timed from the moment they begin to stand up until they are seated again.
Time frame: Baseline, post-treatment (2 weeks) and follow up after 30 days
Independency level
Self-reported independence is assessed using the Functional Ambulation Categories (FAC). Scores range from 0 (inability to walk even with external help) to 5 (normal ambulation).
Time frame: Baseline, post-treatment (2 weeks) and follow up after 30 days
Lower limb motor function
Motor function of the lower limbs is assessed using the Fugl-Meyer Assessment, where scores range from 0 (indicating the worst motor function) to 28 (indicating normal motor function).
Time frame: Baseline, post-treatment (2 weeks) and follow up after 30 days
Balance
Capacity to maintain balance during various tasks is assessed using the Mini Balance Evaluation System (MiniBEST-test). Its scores range from 0 to 28 points. Lower scores indicate poor balance, while higher scores reflect better balance.
Time frame: Baseline, post-treatment (2 weeks) and follow up after 30 days
Perceived change in treatment
Evaluation of how the participant describe the perceived change in their condition since the treatment started, using the Patient Global Impression of Change (PGM). This scale assesses the change in activity limitations, symptoms, emotions, and overall quality of life since the beginning of treatment, ranging from no change or worsening to significant improvement that made a considerable difference. A score of one indicates no change, while a score of seven represents a substantial improvement.
Time frame: Upon completion of the two-week intervention
Spasticity
Muscle tone disorders will be assessed using the Modified Ashworth Scale, which measures spasticity by grading muscle resistance during passive stretching. The scale ranges from 0 to 4, where 0 indicates no increase in muscle tone, and 4 represents a limb that is rigid in flexion or extension.
Time frame: Baseline, post-treatment (2 weeks) and follow up after 30 days
Plan to share: Undecided
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Universidade Federal de Pernambuco