CompletedNot Applicable

The Effect of Superimposed Electrical Stimulation on Sitting Balance, Respiratory Functions, and Abdominal Muscle Thickness in Complete Spinal Cord Injury

Turkey (Türkiye)34 participantsStarted 2022-02-06

Plain-language summary

The primary aim of the current study was to investigate the effects of SiFES (superimposed functional electrical stimulation) on sitting balance in patients with complete Spinal Cord Injury (SCI) compared to exercise alone. Additionally, the study aims to investigate improvements in respiratory functions and changes in abdominal muscle thickness measured by ultrasonography (USG) following SiFES treatment. The fundamental questions that investigators want to answer are as follows: * \[question 1\]: "Does abdominal SiFES therapy improve sitting balance in patients with complete SCI?" * \[question 2\]: "Does abdominal SiFES therapy improve respiratory functions in patients with complete SCI?"

Who can participate

Age range

18 Years – 65 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: * being between 18-65 years old * having a minimum of 3 months since the spinal cord injury * having complete paraplegia according American Spinal Injury Association (ASIA) disorder scale A due to traumatic spinal cord injury * being able to sit unsupported in a wheelchair Exclusion Criteria: * malignancy, * epilepsy, heart failure, * intracardiac defibrillator (ICD) * an open wound in the application area

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

Modified Functional Reach Test (mFRT) (reaching of forward, right, left)

Timeframe: Baseline - week 4

Trial details

NCT IDNCT06104982

SponsorAnkara City Hospital Bilkent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-11

View on ClinicalTrials.gov More Spinal Cord Injury Thoracic trials