AIH-induced Walking Recovery After Subacute SCI
Key facts
- Who runs it
- Spaulding Rehabilitation Hospital
- Where
- Atlanta and Cambridge, United StatesSee the 2 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 125 people, planned
- Started
- Oct 2015
- Expected to end
- 30 Dec 2027
- Type of study
- Interventional, 5 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Daily acute intermittent hypoxia (dAIH)
- dSHAM
- Walking
- Record updated
- 8 July 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 18 to 70 years old
- medically stable with medical clearance from physician to participate
- spinal cord injury (SCI) at or below C3 (phrenic sparing) and above L5 with at least motor function preserved below the neurologic level
- non-progressive etiology of spinal injury
- American Spinal Injury Association Impairment Scale (AIS) grade A-D
- 2-12 months post-injury (subacute)
Who cannot take part
- severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, infection (e.g. bladder), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis (history of fractures), active heterotopic ossification in the lower extremities, or history of peripheral nerve injury in the legs
- history of cardiovascular/pulmonary complications
- score less than 24 on Mini-Mental Exam
- severe autonomic dysreflexia
- pregnancy
- severe obstructive sleep apnea (OSA), characterized by uncontrolled hypoxia and sleep fractionation; Specific inclusion/exclusion criteria for recruiting non-ambulatory subjects:; Participation in this group requires all of the above inclusion/exclusion criteria, as well as being unable to complete any of the below measures:
- timed up-and-go (TUG) test
- 10-meter walk test (10MWT)
- 6-minute walk test (6MWT); Specific inclusion/exclusion criteria for recruiting ambulatory subjects:; Participation in this group requires all of the above criteria, as well as successful completion of at least one below measure:
- timed up-and-go (TUG) test
- 10-meter walk test (10MWT)
- 6-minute walk test (6MWT)
Where in United States
- Shepherd CenterAtlanta, United StatesNo longer taking part
- Spaulding Rehabilitation HospitalCambridge, United StatesNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to determine how mild breathing bouts of low oxygen may restore walking and leg strength in persons who have sustained a spinal cord injury.
The 5 groups in the trial
- Non-ambulatory - dAIHTreatment being tested
Non-ambulatory subjects will be randomly assigned to receive 10 sessions of daily acute intermittent hypoxia (dAIH) 10 treatment visits at a frequency of 5 days each week for 2 weeks.
Treatment: Daily acute intermittent hypoxia (dAIH)
- Non-ambulatory - dSHAMSham treatment, for comparison
Non-ambulatory subjects will be randomly assigned to receive 10 sessions of daily room air (dSHAM) 10 treatment visits at a frequency of 5 days each week for 2 weeks.
Treatment: dSHAM
- Ambulatory - dAIH+WalkTreatment being tested
Ambulatory subjects will be randomly assigned to receive 10 sessions of daily acute intermittent hypoxia (dAIH) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.
Treatment: Daily acute intermittent hypoxia (dAIH) and Walking
- Ambulatory - dSHAM+WalkSham treatment, for comparison
Ambulatory subjects will be randomly assigned to receive 10 sessions of daily room air (dSHAM) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.
Treatment: dSHAM and Walking
- Ambulatory-WalkOther group
Ambulatory subjects will be randomly assigned to 10 sessions of walking practice only for 5 consecutive sessions/week x 2 weeks.
Treatment: Walking
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Intermittent Hypoxia-Induced Recovery of Overground Walking in Persons With Subacute SCI
- Record updated
- 8 July 2026