TRANSSPINAL DIRECT CURRENT STIMULATION ON FUNCTIONAL MOBILITY IN POST-STROKE PATIENTS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transspinal direct current stimulation, Sham Comparator.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of this clinical trial is to investigate the effects of transspinal direct current stimulation on the functional mobility of post-stroke patients. The main question it aims to answer is: Is transspinal direct current stimulation able to improve functional mobility in post-stroke patients? The researchers will compare transspinal direct current stimulation associated with gait training with sham transspinal direct current stimulation associated with gait training. To verify the effects of stimulation on the functional mobility of post-stroke patients. Participants: * They will be assessed before starting the care, after the care has been completed, 15 and 30 days after the care has been completed. * They will take part in 10 sessions of transspinal direct current stimulation associated with gait training.
Interventions
- Device Transspinal direct current stimulation
Direct current electrical stimulation applied non-invasively to the spinal cord. - Device Sham Comparator
transspinal direct current stimulation simulated
Primary outcome measures
- Timed up and go test [Time frame: From the start of treatment until 30 days after the end of treatment.]
Secondary outcome measures (5)
- Functional Ambulation Classification [Time frame: From the start of treatment until 30 days after the end of treatment.]
- Fugl-Meyer Assessment Scale [Time frame: From the start of treatment until 30 days after the end of treatment.]
- Mini-Balance Evaluation Systems Test (MiniBESTest) [Time frame: From the start of treatment until 30 days after the end of treatment.]
- Modified Ashworth scale [Time frame: From the start of treatment until 30 days after the end of treatment.]
- Patient Global Impression of Change Scale [Time frame: Only in the evaluation immediately after treatment.]
Eligibility criteria
Inclusion criteria
- Clinical diagnosis of ischemic or hemorrhagic stroke, provided by a neurologist.
- Age group greater than or equal to 18 years, of both sexes.
- Any stage of the disease.
- Presence of lower limb sensorimotor disorder related to the stroke
- Absence of cognitive impairment verified through the Mini Mental State Examination (score ≥ 18 for illiterate individuals and ≥ 24 for educated individuals) modified for the Brazilian population.
Exclusion criteria
- With other neurological injuries
- With vestibular, visual, cardiovascular or osteomyoarticular disorders of the lower limb that may affect the performance of the proposed tests
- Who have a pacemaker or metallic implants in their spine
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06724367 · 81604324.2.0000.5208