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Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03922802
Recruitment Status Not yet recruiting
First Posted April 22, 2019
Last update posted September 1, 2020
This is a randomized control 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.
OBJECTIVES: - To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training modulates spinal locomotor networks in individuals with spinal cord injury - To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves locomotor function in individuals with spinal cord injury - To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves symmetry of gait in individuals with spinal cord injury - To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves standing posture and balance in individuals with spinal cord injury - To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with a combination of AIH, transcutaneous spinal cord stimulation and ambulation training in individuals with spinal cord injury
|Experimental: Noninvasive Spinal Stimulation with Hypoxia + Gait Training
May receive up to 45 minutes of AIH and up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Intervention: Device: AIH prior to Noninvasive spinal stimulation during gait training
Device: AIH prior to noninvasive spinal stimulation during gait training
Subjects will receive up to 45 minutes of AIH prior to receiving transcutaneous electrical spinal cord stimulation delivered by a Transcutaneous Spinal Cord Neurostimulator while performing locomotor activities.
|Active Comparator: Conventional Gait Training
May receive up to 50 min of locomotion training without hypoxia or transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
Other: Conventional Gait Training
Subjects will perform locomotor activities without AIH or transcutaneous electrical spinal cord stimulation
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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
- Participants who demonstrate at least a 10% change in isometric or isokinetic
plantarflexion, dorsiflexion or knee extension force above baseline after a single
bout of Acute Intermittent Hypoxia (AIH) during screening
- 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
- Modified Ashworth score of 3 or greater in lower extremity
- 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
- 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
Contact: Kelly A McKenzie, PT, DPT, NCS 312-238-7111 firstname.lastname@example.org
Contact: Lindsey Yingling, PT, DPT, NCS 312-238-1063 email@example.com
United States, Illinois
Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
University of California, Los Angeles
Principal Investigator: Arun Jayaraman, PT, PhD Shirley Ryan AbilityLab