Gait Disorders, Neurologic, Stroke Rehabilitation, tDCS
Conditions
Keywords
spinal cord, stroke, gait, rehabilitation, direct current stimulation
Brief summary
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.
Interventions
csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes.
DEVICESham Comparator
Masking for cerebello-spinal direct current stimulation involves the electric current stopping after 30 seconds, providing a sensation without producing neuromodulation.
Sponsors
Universidade Federal do Rio de Janeiro
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Universidade Federal de Pernambuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized controlled clinical trial, double blinded (therapist/evaluator, patient) Initial evaluation, followed by 10 days of treatment, followed by a re-evaluation immediately after and follow-up 30 days after finishing.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Confirmation of Stroke by digital or physical imaging or medical report * Gait impairment * Stroke with at least 6 months after ictus
Exclusion criteria
* Metallic implants in spinal cord * Major orthopedic/rheumatological disorders * Inability of verbal or non-verbal communication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Mobility | Baseline, post-treatment (2 weeks) and follow up after 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Independency level | Baseline, post-treatment (2 weeks) and follow up after 30 days | 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). |
| Lower limb motor function | Baseline, post-treatment (2 weeks) and follow up after 30 days | 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). |
| Balance | Baseline, post-treatment (2 weeks) and follow up after 30 days | 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. |
| Perceived change in treatment | Upon completion of the two-week intervention | 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. |
| Spasticity | Baseline, post-treatment (2 weeks) and follow up after 30 days | 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. |
Countries
Brazil
Contacts
Primary ContactDANIEL MELO, Bachelor in physical therapy
Outcome results
None listed