About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Transspinal direct current stimulation
DeviceDirect current electrical stimulation applied non-invasively to the spinal cord.
Sham Comparator
Devicetransspinal direct current stimulation simulated
Treatment groups
Trial outcomes
Primary outcomes
Timed up and go test
It is an easy-to-use clinical tool that assesses functional mobility. It consists of measuring the time in which an individual is able to get up from a chair, walk for three meters, turn around, go back and sit down again. The test will be carried out three consecutive times, with a 1-minute interval between each attempt, and the value adopted will be the average time (in seconds) taken to carry out the three attempts. It will be measured before starting treatment, immediately afterwards, 15 and 30 days after the end of treatment.
Secondary outcomes
Functional Ambulation Classification
The Functional Ambulation Classification (FAC) serves as a parameter for monitoring gait progress during rehabilitation, categorically. It also makes it possible to assess the ability to walk for at least three meters on flat and uneven surfaces, as well as analyzing the ability to walk on ramps and up and down steps. The scale is scored from 1 (non-functional) to 6 (independent on level and uneven surfaces), i.e. the higher the score, the better the outcome. It will be measured before starting treatment, immediately afterwards, 15 and 30 days after the end of treatment.
Fugl-Meyer Assessment Scale
The Fugl-Meyer Assessment Scale is a quantitative instrument used to assess sensorimotor rehabilitation after stroke. Sections E and F, referring to the lower limb, will be used, with a maximum total score of 34 points, and higher scores reflecting better outcomes. It will be measured before starting treatment, immediately afterwards, 15 and 30 days after the end of treatment.
Mini-Balance Evaluation Systems Test (MiniBESTest)
The Mini-Balance Evaluation Systems Test is a validated scale capable of evaluating balance in patients with neurological disorders. It consists of 14 items and higher scores imply better outcomes. It will be measured before starting treatment, immediately afterwards, 15 and 30 days after the end of treatment.
Modified Ashworth scale
The modified Ashworth scale is a 6-point ordinal scale that grades the resistance encountered during passive muscle stretching, with higher values representing worse outcomes. It will be applied to the following joints: hip (flexion, extension, abduction and adduction); knee (flexion and extension) and ankle (plantar flexion and dorsiflexion). It will be measured before starting treatment, immediately afterwards, 15 and 30 days after the end of treatment.
Locations
Sponsors and contacts
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