AIH-induced Walking Recovery After Subacute SCI
- Conditions
- Spinal Cord Injury
- Interventions
- Other: Daily acute intermittent hypoxia (dAIH)Other: dSHAMOther: Walking
- Registration Number
- NCT02632422
- Lead Sponsor
- Spaulding Rehabilitation Hospital
- Brief Summary
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.
- Detailed Description
The goal of the study is to determine whether repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) improves recovery of walking and strength after spinal cord injury. This idea stems from animal studies on respiration, in which investigators showed that mild AIH improves breathing in rats with spinal injuries. These studies showed that AIH induces plasticity, strengthening neural connections by increasing the production of key proteins and improving the sensitivity of spinal cord circuitry. The ultimate goal of this research is to assess the potential of mild AIH as a therapeutic approach not only in persons with chronic spinal cord injury but also in persons with subacute injury. By applying AIH during early stages of recovery, the investigators hope to expand the potential benefits of AIH to a broader range of persons with spinal injury, thereby improving functional independence and quality of life for servicemen and civilians.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 125
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ambulatory - dAIH+Walk Daily acute intermittent hypoxia (dAIH) 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. Non-ambulatory - dAIH Daily acute intermittent hypoxia (dAIH) 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. Non-ambulatory - dSHAM dSHAM 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. Ambulatory - dAIH+Walk Walking 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. Ambulatory - dSHAM+Walk dSHAM 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. Ambulatory - dSHAM+Walk Walking 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. Ambulatory-Walk Walking Ambulatory subjects will be randomly assigned to 10 sessions of walking practice only for 5 consecutive sessions/week x 2 weeks.
- Primary Outcome Measures
Name Time Method Change in walking recovery, assessed by 6 minute walk test (6MWT) Baseline, Post-session 10 (up to two weeks) Participants perform the 6MWT at their fastest, most comfortable walking speed sustainable for 6 minutes. Distances will be recorded at 2 and 6 minutes. The test will be based upon the participant's ability to finish each assessment without human assistance. Change is the difference between the end of session 10 and baseline.
Change in walking recovery, assessed by 10 meter walk test (10MWT) Baseline, Post-session 10 (up to two weeks) Participants walk ten meters without assistance at their fastest, but safest speed with a minimum of 1-minute of rest between two trials. Average speed across the up to three 10MWT trials will be used for analysis. Change is the difference between the end of session 10 and baseline.
Change in walking recovery, assessed by timed up-and-go (TUG) test Baseline, Post-session 10 (up to two weeks) The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair. Participants will perform up to three trials of the TUG test. Average speed across TUG trials will be used for analysis. Change is the difference between the end of session 10 and baseline.
- Secondary Outcome Measures
Name Time Method Change in spasticity Baseline, Post-session 10 (up to two weeks) Spasticity will be assessed using the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS). The study team will quantify the total lower extremity spasticity score using the cumulative sum of 3 SCATS subscales: clonus (0=no spasticity; 3=severe), flexor (0=no spasticity; 3=severe), and extensor (0=no spasticity; 3=severe). Change is the difference between the end of session 10 and baseline.
Systemic hypertension incidence rate Post-session 10 (up to two weeks) Participants will have their systolic and diastolic blood pressure measured. A systemic hypertensive event is quantified as a systolic pressure exceeding 140mmHg and/or diastolic pressure exceeding 90mmHg. A hypertension incident rate is the number of hypertensive events divided by the total person-time. Person-time is in units of person-measures (the sum of the total number of BP measurements) taken for each person. Person-measures accounts for the total number of chances for detecting a hypertensive event and accounts for measurements not made due to drop-out or a disqualifying adverse event
Autonomic dysreflexia incidence rate Post-session 10 (up to two weeks) The occurrence of autonomic dysreflexia will be assessed. An autonomic dysreflexia event will constitute a participant having a systolic blood pressure (SBP) increase from baseline of 20mmHg or SBP greater than 150mmHg with complaints of headache, diaphoresis, and/or blurred vision and will be diagnosed by the study team clinicians.
Change in pain severity Baseline, Post-session 10 (up to two weeks) Participants will report their pain level using the Wong-Baker FACES scale. The scale is from 0 to 5; 0 being no pain and 5 being extreme pain. Change is the difference between the end of session 10 and baseline.
Trial Locations
- Locations (2)
Shepherd Center
🇺🇸Atlanta, Georgia, United States
Spaulding Rehabilitation Hospital
🇺🇸Cambridge, Massachusetts, United States