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| Name | Class |
|---|---|
| Universidade Federal do Rio de Janeiro | OTHER |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active cerebello-spinal direct current stimulation | Experimental | csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes. |
|
| Sham cerebello-spinal direct current stimulation | Sham Comparator | Treadmill training with masking for cerebello-spinal direct current stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebello-spinal direct current stimulation | Device | csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-treatment (2 weeks) and follow up after 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, post-treatment (2 weeks) and follow up after 30 days |
| Lower limb motor function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DANIEL MELO, Bachelor in physical therapy | Contact | 81995173332 | +55 | gmelodaniel@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Paraiba | Recruiting | João Pessoa | ParaÃba | 58051-900 | Brazil |
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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.
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|
| Sham Comparator | Device | Masking for cerebello-spinal direct current stimulation involves the electric current stopping after 30 seconds, providing a sensation without producing neuromodulation. |
|
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). |
| 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. | 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. | 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. | Baseline, post-treatment (2 weeks) and follow up after 30 days |
| Federal University of Pernambuco | Recruiting | Recife | Pernambuco | 50670-420 | Brazil |
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| Federal University of Rio de Janeiro | Recruiting | Rio de Janeiro | Rio de Janeiro | 23510-220 | Brazil |
|
| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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