CompletedNot Applicable

SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training

United States14 participantsStarted 2020-12-01

Plain-language summary

This is a single blind, sham controlled crossover trial that will evaluate the effectiveness of acute intermittent hypoxia therapy (AIH) combined with transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals after spinal cord injury.

Who can participate

Age range

18 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: * Participants have been diagnosed with a spinal cord injury below level C2 * ASIA Impairment Scale Grade A-D * Participants are 18 years of age or older * Participants are at least 6 months post spinal cord injury * Participants with paraplegia or tetraplegia secondary to a single spinal cord injury * Participants are able to provide informed consent * Participants are not currently receiving regular physical therapy services Exclusion Criteria: * Individuals less than 18 years of age * Individuals less than 6 months post spinal cord injury * Individuals with ataxia * Individuals with multiple spinal cord injury history * Pregnancy or nursing * Pacemaker or anti-spasticity implantable pumps * Active pressure sores * Unhealed bone fractures * Peripheral neuropathies * Painful musculoskeletal dysfunction due to active injuries or infections * Severe contractures in the lower extremities * Active urinary tract infection * Clinically significant depression, psychiatric disorders, or ongoing drug abuse * Diagnosed with any of the following medical conditions: congestive heart failure, cardiac arrhythmias, uncontrolled hypertension, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction, or known carotid/intracerebral artery stenosis * Individuals with a tracheostomy or who utilize mechanical ventilation. * Individuals who are currently enrolled in another interventional research study …

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

Change in 6 Minute Walk Test

Timeframe: Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up)

Trial details

NCT IDNCT03922802

SponsorShirley Ryan AbilityLab

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-03

Results submitted2025-04-09

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Who can participate

Age range

18 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.