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NCT Number: NCT06593184

Efficacy of Trans-spinal Magnetic Stimulation on Functional Mobility in Chronic Stroke Patients

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Paraiba, João Pessoa, Paraíba, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans-spinal magnetic stimulation

Device

Trans-spinal magnetic stimulation activates afferent spinal roots and increases cortical excitability.

Other names: tsMS, transcutaneous spinal cord magnetic stimulation

Sham Comparator

Device

Sham trans-spinal magnetic stimulation involves masking, where the sound of stimulation persists even though no magnetic pulses are delivered

Primary outcomes

  1. Functional Mobility

    Time frame: 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 outcomes

  1. Independency level

    Time frame: 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).

  2. Lower limb motor function

    Time frame: 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).

  3. Balance

    Time frame: 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.

  4. Perceived change in treatment

    Time frame: 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.

  5. Spasticity

    Time frame: 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.

  6. Sensory Function

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel G Melo, Physical Therapy

CONTACT

[email protected]

55 + 81995173332

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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