Clinical trial NCT06593184: Efficacy of Trans-spinal Magnetic Stimulation on Functional Mobility in Chronic Stroke Patients
Official title: Efficacy of Trans-spinal Magnetic Stimulation on Functional Mobility in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Sequelae
Gait Disorders, Neurologic
Stroke
Keywords: Spinal cord
Magnetic Stimulation
Trans-spinal magnetic stimulation
Stroke
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional Mobility
timeFrame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Secondary outcomes:
measure: Independency level
timeFrame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
measure: Lower limb motor function
timeFrame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
measure: Balance
timeFrame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
measure: Perceived change in treatment
timeFrame: End of treatment (2 weeks)
measure: Spasticity
timeFrame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
measure: Sensory Function
timeFrame: Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Federal University of Paraiba
state: Paraíba
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
city: Rio de Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
Study officials:
References: