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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
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.
Subjects will perform locomotor activities with transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
Shirley Ryan AbilityLab
Chicago, Illinois, United States
Change in 6 Minute Walk Test
The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assertive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test was completed at 4 time points within each arm: 1) Baseline prior to starting each arm, 2) intervention session 5 within each arm (T5), 3) 3 days after the intervention sessions were complete for the given arm (POST), and 4) 1 week after all intervention sessions were complete for a given arm (1-week follow up)
Time frame: 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)
Change in 10 Meter Walk Test, Fast Velocity
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed: 1) Baseline prior to starting each arm, 2) intervention session 5 within each arm (T5), 3) 3 days after the intervention sessions were complete for the given arm (POST), and 4) 1 week after all intervention sessions were complete for a given arm (1-week follow up)
Time frame: 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)
Timed Up and Go Test: Assesses Mobility, Balance, Walking Ability and Fall Risk
The participant starts seated in a chair with his/her back against the chair back. On command, the participant rises from the chair, walks 3 meters, turns, walks back to the chair and sits down. Timing begins when the command to start is given and stops when the participant returns to a seated position. 1) Baseline prior to starting each arm, 2) intervention session 5 within each arm (T5), 3) 3 days after the intervention sessions were complete for the given arm (POST), and 4) 1 week after all intervention sessions were complete for a given arm (1-week follow up)
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Subjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
Time frame: 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)