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The goal of this clinical trial is to learn if trans-spinal magnetic stimulation works to treat gait disorders in chronic stroke adults. It will also learn about the safety of trans-spinal magnetic stimulation.
The main questions it aims to answer are:
Does trans-spinal magnetic stimulation enhance chronic stroke participants gait and functional mobility? Does the technique cause any side effects?
Researchers will compare trans-spinal magnetic stimulation to a sham (a look-alike stimulation with no real effect) to see if trans-spinal magnetic stimulation works to treat gait disorders and improve functional mobility.
Participants will:
Receive trans-spinal magnetic stimulation with treadmill training or a sham stimulation with treadmill training every day for 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active trans-spinal magnetic stimulation | Experimental | Trans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability. |
|
| Sham trans-spinal magnetic stimulation | Sham Comparator | Treadmill training with masking for trans-spinal magnetic stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans-spinal magnetic stimulation | Device | Trans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability. |
|
| 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. | Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment |
| 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). | Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment |
| Lower limb motor function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel G Melo, Physical Therapy | Contact | 55 + 81995173332 | 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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| 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 |
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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 | Sham trans-spinal magnetic stimulation involves masking, where the sound of stimulation persists even though no magnetic pulses are delivered |
|
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). |
| Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment |
| 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. | Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment |
| Perceived change in treatment | Evaluation of how the participant describes 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. | End of treatment (2 weeks) |
| Spasticity | Tonus 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. | Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment |
| Sensory Function | Assessed using a method inspired by the ASIA scale, evaluating the lower thoracic, mid-thoracic, and lower cervical dermatomes, where a score of 0 indicates absence of sensitivity and 2 indicates normal sensitivity. | Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment |
| Federal University of Pernambuco | Recruiting | Recife | Pernambuco | 50670-420 | Brazil |
|
| Federal University of Rio de Janeiro | Recruiting | Rio de Janeiro | Rio de Janeiro | 23510-220 | Brazil |
|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |