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

Not Applicable

Recruiting

• Conditions: Stroke Sequelae; Gait Disorders, Neurologic; Stroke

• Registration Number: NCT06593184
• Lead Sponsor: Universidade Federal de Pernambuco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-06-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.
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.
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).
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.

Trial Locations

Locations (3)

Federal University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil

Federal University of Pernambuco; 🇧🇷 Recife, Pernambuco, Brazil

Federal University of Paraiba; 🇧🇷 João Pessoa, Paraíba, Brazil