Trial Outcomes & Findings for SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training (NCT NCT03922802)
NCT ID: NCT03922802
Last Updated: 2026-01-13
Results Overview
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)
COMPLETED
NA
14 participants
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)
2026-01-13
Participant Flow
All participants completed all arms of the study. The order of arm completion was randomly assigned using a block style approach.
Participant milestones
| Measure |
All Study Participants
All participants completed 3 arms of the study, in a random order: 1) Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training, 2) Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training, 3) Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
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|---|---|
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Overall Study
STARTED
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14
|
|
Overall Study
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
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10
|
|
Overall Study
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
|
10
|
|
Overall Study
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
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10
|
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Overall Study
COMPLETED
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10
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
All Study Participants
All participants completed 3 arms of the study, in a random order: 1) Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training, 2) Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training, 3) Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
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|---|---|
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Overall Study
Withdrawal by Subject
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4
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Baseline Characteristics
SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
All participants completed 3 arms of the study, in a random order: 1) Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training, 2) Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training, 3) Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=210 Participants
|
|
Age, Categorical
Between 18 and 65 years
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9 Participants
n=210 Participants
|
|
Age, Categorical
>=65 years
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1 Participants
n=210 Participants
|
|
Age, Continuous
|
46.90 years
STANDARD_DEVIATION 16.53 • n=210 Participants
|
|
Sex: Female, Male
Female
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2 Participants
n=210 Participants
|
|
Sex: Female, Male
Male
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8 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=210 Participants
|
|
Race (NIH/OMB)
White
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7 Participants
n=210 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
|
Region of Enrollment
United States
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10 Participants
n=210 Participants
|
|
Gait Speed as measured by the 10-meter walk test (10MWT) at self-selected velocity (SSV
|
0.63 meters per second (m/s)
STANDARD_DEVIATION 0.30 • n=210 Participants
|
PRIMARY outcome
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)Population: 10 participants completed and analyzed. 1 was dropped from analysis as an outlier (difference of greater than 1.5\*IQR (interquartile range) for all gait outcomes) = 9 participants in analysis total.
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)
Outcome measures
| Measure |
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
n=9 Participants
May receive up to 45 minutes of AIH prior to 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
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + 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.
|
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
n=9 Participants
May receive up to 45 minutes of Sham AIH prior to 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.
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training: Subjects will perform locomotor activities with transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
|
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
n=9 Participants
May receive up to 45 minutes of Sham AIH prior to up to 50 min of locomotion training with sham 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.
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training: Subjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
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|---|---|---|---|
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Change in 6 Minute Walk Test
Baseline to T5 (7-8 days after baseline from stated arm)
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19.57 meters (m)
Interval 3.68 to 35.46
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12.28 meters (m)
Interval -1.58 to 26.13
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9.63 meters (m)
Interval -6.45 to 25.71
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Change in 6 Minute Walk Test
Baseline to POST (10-11 days after baseline from stated arm)
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19.03 meters (m)
Interval 2.94 to 35.13
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12.01 meters (m)
Interval -7.41 to 31.44
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15.63 meters (m)
Interval 6.29 to 24.98
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Change in 6 Minute Walk Test
Baseline to 1-week follow up (17-19 days after baseline from stated arm)
|
21.80 meters (m)
Interval 3.5 to 40.1
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10.33 meters (m)
Interval -8.33 to 29.0
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16.13 meters (m)
Interval -0.36 to 32.62
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SECONDARY outcome
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)Population: 14 participants enrolled. 4 dropped out of the study due to personal or transportation reasons; therefore, 10 participants completed and analyzed. 1 was dropped from analysis as an outlier (difference of greater than 1.5\*IQR (interquartile range) for all gait outcomes) = 9 participants in analysis total.
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)
Outcome measures
| Measure |
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
n=9 Participants
May receive up to 45 minutes of AIH prior to 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
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + 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.
|
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
n=9 Participants
May receive up to 45 minutes of Sham AIH prior to 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.
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training: Subjects will perform locomotor activities with transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
|
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
n=9 Participants
May receive up to 45 minutes of Sham AIH prior to up to 50 min of locomotion training with sham 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.
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training: Subjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
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|---|---|---|---|
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Change in 10 Meter Walk Test, Fast Velocity
Baseline to POST (10-11 days after baseline from stated arm)
|
0.05 meters per second
Interval 0.01 to 0.09
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-0.01 meters per second
Interval -0.07 to 0.05
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0.02 meters per second
Interval -0.02 to 0.07
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|
Change in 10 Meter Walk Test, Fast Velocity
Baseline to T5 (7-8 days after baseline from stated arm)
|
0.03 meters per second
Interval -0.02 to 0.08
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0.00 meters per second
Interval -0.05 to 0.04
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0.04 meters per second
Interval -0.01 to 0.1
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Change in 10 Meter Walk Test, Fast Velocity
Baseline to 1-week follow up (17-19 days after baseline from stated arm)
|
0.03 meters per second
Interval -0.03 to 0.1
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0.01 meters per second
Interval -0.09 to 0.12
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-0.01 meters per second
Interval -0.08 to 0.05
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SECONDARY outcome
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)Population: 14 participants enrolled. 4 dropped out of the study due to personal or transportation reasons; therefore, 10 participants completed and analyzed. 1 was dropped from analysis as an outlier (difference of greater than 1.5\*IQR (interquartile range) for all gait outcomes) = 9 participants in analysis total.
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)
Outcome measures
| Measure |
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
n=9 Participants
May receive up to 45 minutes of AIH prior to 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
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + 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.
|
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
n=9 Participants
May receive up to 45 minutes of Sham AIH prior to 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.
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training: Subjects will perform locomotor activities with transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
|
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
n=9 Participants
May receive up to 45 minutes of Sham AIH prior to up to 50 min of locomotion training with sham 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.
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training: Subjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
|
|---|---|---|---|
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Timed Up and Go Test: Assesses Mobility, Balance, Walking Ability and Fall Risk
Baseline to T5 (7-8 days after baseline from stated arm)
|
2.67 seconds
Interval 0.18 to 5.16
|
1.45 seconds
Interval -0.94 to 3.84
|
1.00 seconds
Interval 0.0 to 2.0
|
|
Timed Up and Go Test: Assesses Mobility, Balance, Walking Ability and Fall Risk
Baseline to POST (10-11 days after baseline from stated arm)
|
3.39 seconds
Interval 1.1 to 5.68
|
-0.06 seconds
Interval -1.42 to 1.31
|
0.73 seconds
Interval -0.75 to 2.2
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Timed Up and Go Test: Assesses Mobility, Balance, Walking Ability and Fall Risk
Baseline to 1-week follow up (17-19 days after baseline from stated arm)
|
3.49 seconds
Interval 0.56 to 6.43
|
0.78 seconds
Interval -0.51 to 2.06
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0.19 seconds
Interval -1.5 to 1.88
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Adverse Events
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kelly Mckenzie, Research Physical Therapist
Shirley Ryan AbilityLab
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place