Efficacy of Trans-spinal Magnetic Stimulation on Functional Mobility in Chronic Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversidade Federal de Pernambuco
About this trial
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
This trial does not accept healthy volunteersQualifiers
Confirmation of Stroke by digital or physical imaging or medical report
Gait impairment
Stroke with at least 6 months after ictus
Disqualifiers
Metallic implants in spinal cord
Major orthopedic/rheumatological disorders
Incapacity of verbal or non-verbal communication
Trial design
Design model
Parallel
Treatments tested in this trial
Trans-spinal magnetic stimulation
DeviceTrans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability.
Sham Comparator
DeviceSham trans-spinal magnetic stimulation involves masking, where the sound of stimulation persists even though no magnetic pulses are delivered
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Active trans-spinal magnetic stimulationExperimental treatment 1 intervention
Group B: Sham trans-spinal magnetic stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatmentSecondary outcomes
1
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).
Time frame
Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment2
Lower limb motor function
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).
Time frame
Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment3
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.
Time frame
Enrollment (Day 0); End of treatment (2 weeks); Follow-up after 30 days post-treatment4
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.
Time frame
End of treatment (2 weeks)Sponsors and contacts
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Source ClinicalTrials.gov