Under construction – not a live service
Sign in
Active, not recruitingNo phase

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