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AIH-induced Walking Recovery After Subacute SCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02632422
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Last Update Posted : February 8, 2023
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Randy Trumbower, PT, PhD, Spaulding Rehabilitation Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Other: Daily acute intermittent hypoxia (dAIH) Other: dSHAM Other: Walking Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intermittent Hypoxia-Induced Recovery of Overground Walking in Persons With Subacute SCI
Actual Study Start Date : October 2015
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Non-ambulatory - 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.
 Other: Daily acute intermittent hypoxia (dAIH)
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).
Sham Comparator: Non-ambulatory - 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.
 Other: dSHAM
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).
Experimental: Ambulatory - dAIH+Walk
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.
 Other: Daily acute intermittent hypoxia (dAIH)
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).

Other: Walking

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
Sham Comparator: Ambulatory - dSHAM+Walk
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.
 Other: dSHAM
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).

Other: Walking

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
Ambulatory-Walk
Ambulatory subjects will be randomly assigned to 10 sessions of walking practice only for 5 consecutive sessions/week x 2 weeks.
 Other: Walking

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


Outcome Measures
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Primary Outcome Measures :
  1. Change in walking recovery, assessed by timed up-and-go (TUG) test [ Time Frame: 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.

  2. Change in walking recovery, assessed by 6 minute walk test (6MWT) [ Time Frame: 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.

  3. Change in walking recovery, assessed by 10 meter walk test (10MWT) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in pain severity [ Time Frame: 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.

  2. Change in spasticity [ Time Frame: 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.

  3. Systemic hypertension incidence rate [ Time Frame: 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

  4. Autonomic dysreflexia incidence rate [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632422


Locations
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United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, Massachusetts
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
United States Department of Defense
Investigators
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Principal Investigator: Randy Trumbower, PT, PhD Harvard Medical School (HMS and HSDM)
More Information
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Additional Information:

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Requests for study informed consent may be made using the lab's contact form.

Publications of Results:

Other Publications:

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Responsible Party: Randy Trumbower, PT, PhD, Assistant Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02632422    
Other Study ID Numbers: 2017P001941
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Randy Trumbower, PT, PhD, Spaulding Rehabilitation Hospital:
walk
rehabilitation
strength
 movement
spinal cord trauma
spinal cord injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries