Gait Disorders, Neurologic, Stroke, Stroke Sequelae
Conditions
Keywords
Spinal cord, Magnetic Stimulation, Trans-spinal magnetic stimulation, Stroke
Brief summary
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.
Interventions
DEVICETrans-spinal magnetic stimulation
Trans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability.
DEVICESham Comparator
Sham trans-spinal magnetic stimulation involves masking, where the sound of stimulation persists even though no magnetic pulses are delivered
Sponsors
Universidade Federal de Pernambuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
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 * Incapacity of verbal or non-verbal communication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Mobility | Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment | 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 |
|---|---|---|
| Lower limb motor function | Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment | 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 | Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment | 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. |
| Independency level | Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment | 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). |
| Spasticity | Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment | 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. |
| Sensory Function | Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment | 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. |
| Perceived change in treatment | End of treatment (2 weeks) | 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. |
Countries
Brazil
Contacts
Primary ContactDaniel G Melo, Physical Therapy
Outcome results
None listed