AIH-induced Walking Recovery After Subacute SCI
Intermittent Hypoxia-Induced Recovery of Overground Walking in Persons With Subacute SCI
1 other identifier
interventional
125
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 14, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
ExpectedOctober 31, 2025
October 1, 2025
7.8 years
December 14, 2015
October 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in walking recovery, assessed by timed up-and-go (TUG) test
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.
Baseline, Post-session 10 (up to two weeks)
Change in walking recovery, assessed by 6 minute walk test (6MWT)
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.
Baseline, Post-session 10 (up to two weeks)
Change in walking recovery, assessed by 10 meter walk test (10MWT)
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.
Baseline, Post-session 10 (up to two weeks)
Secondary Outcomes (4)
Change in pain severity
Baseline, Post-session 10 (up to two weeks)
Change in spasticity
Baseline, Post-session 10 (up to two weeks)
Systemic hypertension incidence rate
Post-session 10 (up to two weeks)
Autonomic dysreflexia incidence rate
Post-session 10 (up to two weeks)
Study Arms (5)
Non-ambulatory - dAIH
EXPERIMENTALNon-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
SHAM COMPARATORNon-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
EXPERIMENTALAmbulatory 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
SHAM COMPARATORAmbulatory 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
OTHERAmbulatory subjects will be randomly assigned to 10 sessions of walking practice only for 5 consecutive sessions/week x 2 weeks.
Interventions
Each participant will be exposed to 10 sessions of daily acute intermittent hypoxia (dAIH) via air generators. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes which include intervals of 1.5 minute hypoxia (FIO2=0.10±0.02, i.e. 10% O2) and 1 minute normoxia (FIO2=0.21±0.02). Participants will receive 5 consecutive days of daily acute intermittent hypoxia (dAIH).
Each participant will be exposed to 10 sessions of daily room air (dSHAM) via air generators. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes of 1.5 minute normoxia (FIO2=0.21±0.02). Participants will receive 5 consecutive days of daily room air (dSHAM).
Participants will participate in 10 days of walking practice sessions. Walking practice sessions will immediately follow (within 60 minutes) the breathing intervention during training visits and will last for 60 minutes. Walking practice will incorporate 5 walking-related tasks: 1. walking balance (e.g., walking with turns) 2. skilled walking tasks (e.g., negotiating obstacles) 3. walking with secondary task (e.g., walking and talking) 4. endurance 5. speed
Eligibility Criteria
You may qualify if:
- 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
- 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
- timed up-and-go (TUG) test
- meter walk test (10MWT)
- minute walk test (6MWT)
- 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
- meter walk test (10MWT)
- minute walk test (6MWT)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shepherd Center
Atlanta, Georgia, 30309, United States
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, 02138, United States
Related Publications (8)
Trumbower RD, Hayes HB, Mitchell GS, Wolf SL, Stahl VA. Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. Neurology. 2017 Oct 31;89(18):1904-1907. doi: 10.1212/WNL.0000000000004596. Epub 2017 Sep 29.
PMID: 28972191BACKGROUNDHayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.
PMID: 24285617BACKGROUNDTrumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5.
PMID: 21821826BACKGROUNDHayes HB, Chvatal SA, French MA, Ting LH, Trumbower RD. Neuromuscular constraints on muscle coordination during overground walking in persons with chronic incomplete spinal cord injury. Clin Neurophysiol. 2014 Oct;125(10):2024-35. doi: 10.1016/j.clinph.2014.02.001. Epub 2014 Feb 14.
PMID: 24618214BACKGROUNDPeters DM, Thibaudier Y, Deffeyes JE, Baer GT, Hayes HB, Trumbower RD. Constraints on Stance-Phase Force Production during Overground Walking in Persons with Chronic Incomplete Spinal Cord Injury. J Neurotrauma. 2018 Feb 1;35(3):467-477. doi: 10.1089/neu.2017.5146. Epub 2017 Oct 27.
PMID: 28762876BACKGROUNDSohn WJ, Tan AQ, Hayes HB, Pochiraju S, Deffeyes J, Trumbower RD. Variability of Leg Kinematics during Overground Walking in Persons with Chronic Incomplete Spinal Cord Injury. J Neurotrauma. 2018 Nov 1;35(21):2519-2529. doi: 10.1089/neu.2017.5538. Epub 2018 Jun 5.
PMID: 29648987BACKGROUNDNaidu A, Peters DM, Tan AQ, Barth S, Crane A, Link A, Balakrishnan S, Hayes HB, Slocum C, Zafonte RD, Trumbower RD. Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol. BMC Neurol. 2020 Jul 8;20(1):273. doi: 10.1186/s12883-020-01851-9.
PMID: 32641012BACKGROUNDTan AQ, Papadopoulos JM, Corsten AN, Trumbower RD. An automated pressure-swing absorption system to administer low oxygen therapy for persons with spinal cord injury. Exp Neurol. 2020 Nov;333:113408. doi: 10.1016/j.expneurol.2020.113408. Epub 2020 Jul 17.
PMID: 32682613RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Randy Trumbower, PT, PhD
Harvard Medical School (HMS and HSDM)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 14, 2015
First Posted
December 16, 2015
Study Start
October 1, 2015
Primary Completion
July 7, 2023
Study Completion (Estimated)
December 30, 2027
Last Updated
October 31, 2025
Record last verified: 2025-10