Combining hypoxia therapy and spinal stimulation with gait training for spinal cord injury recovery
Locomotor Function Following Acute Intermittent Hypoxia (AIH) and Transcutaneous Electrical Spinal Cord Stimulation (tSCS) With Gait Therapy Versus Traditional Gait Therapy in Individuals With Spinal Cord Injury
This study is testing if combining a special breathing therapy and spinal stimulation with walking practice can help people with spinal cord injuries walk better and more efficiently.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT03922802 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of acute intermittent hypoxia therapy combined with non-invasive spinal cord stimulation during gait training for individuals with spinal cord injuries. It aims to determine if this combination can enhance spinal locomotor networks, improve locomotor function, and increase gait symmetry, balance, and ambulation efficiency. The study employs a single-blind, sham-controlled crossover design to assess these outcomes. Participants will undergo various interventions, including both active and sham treatments, to compare their effects on recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with spinal cord injuries below level C2, who are at least 6 months post-injury and can provide informed consent.
Not a fit: Patients with multiple spinal cord injuries, severe contractures, or those currently receiving physical therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for individuals with spinal cord injuries.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination of therapies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 or in therapy related to upper extremity function. * Participants will be excluded if they have had a botulinum toxin injection to lower extremity musculature within the last 3 months. Participants will need to refrain from lower extremity botulinum toxin injections for the duration of the study. If participants wean off antispasticity medications to successfully complete the responsiveness to AIH screening session, they will need to refrain from the medications for the duration of the study. * Documented sleep apnea. * Orthopedic injuries or surgeries that would impact an individual's ability to use the lower extremity. * Traumatic brain injury or other neurological conditions that would impact the study. * Blood hemoglobin levels less than 10g/dL. We will not include the following populations: * Adults unable to consent, unless accompanied by a legally authorized representative. * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Arun Jayaraman, PT, PhD — Shirley Ryan AbilityLab
- Study coordinator: Kelly A McKenzie, PT, DPT, NCS
- Email: kmckenzie@sralab.org
- Phone: 312-238-7111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.