AIH-induced Walking Recovery After Subacute SCI

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT02632422

Run by

Spaulding Rehabilitation Hospital

People needed

125

Starts

2015-10-01

Expected to finish

2027-12-30

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• score less than 24 on Mini-Mental Exam
• severe autonomic dysreflexia
• history of cardiovascular/pulmonary complications
• 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 it is running

• Shepherd Center — Atlanta, Georgia, United States
• Spaulding Rehabilitation Hospital — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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