Not Yet RecruitingNot Applicable

Investigating the Impact of Spinal Cord Electrical Stimulation Combined With Individualized Physical Therapy on Lower Extremity Function in Patients With Spinal Cord Injury

Taiwan76 participantsStarted 2025-08-01

Plain-language summary

This study aims to understand the differences in the effects of two rehabilitation approaches on lower limb function recovery in patients with spinal cord injuries: 1. Spinal cord stimulation (SCS) combined with one-on-one physical therapy 2. One-on-one physical therapy alone

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged between 20 and 70 years. * Diagnosed with spinal cord injury, classified as ASIA Grade A-D. * Neurological level of injury between T1 and L2. * Spinal cord injury has stabilized (for at least 3 months). * Currently receiving standard treatment at Hualien Tzu Chi Hospital and referred by a neurosurgeon or orthopedic surgeon to receive spinal cord stimulation (SCS) and/or individualized physical therapy. * Capable of participating in one-on-one physical therapy sessions 3 to 5 times per week, and assessed by the medical team as able to complete at least a 3 weeks course of treatment. * Fully conscious, able to understand the study information, and willing to sign the consent form and participate in the full assessment process. Exclusion Criteria: * Individuals with severe brain injury, neurodegenerative diseases, or other major neurological disorders. * Those with severe fractures, joint contractures, or conditions preventing participation in lower limb training. * Individuals with a cardiac pacemaker or who are pregnant. * Those unable to comply with the treatment or assessment procedures.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

American Spinal Injury Association (ASIA) Impairment Scale

Timeframe: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.

Modified Ashworth Scale (MAS)

Handheld Dynamometer

Spinal Cord Independence Measure (SCIM III)

World Health Organization Quality-of-Life Scale

Trial details

NCT IDNCT07037628

SponsorLian-Cing Yan, MSPT

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-31

Contact for this trial

LIAN-CING YAN

+88638561825 cingcingyan@gmail.com

View on ClinicalTrials.gov More Spinal Cord Injury trials