SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training (NCT03922802) | Clinical Trial Compass
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 range18 Years
SexALL
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 …
What they're measuring
1
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)