Spinal Cord InjuriesNCT01272011
Effects of Breathing and Walking Treatments on Recovery Post-Spinal Cord Injury
A study testing Intermittent Hypoxia and Locomotor Training in people with Spinal Cord Injuries and Brown Sequard, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Change to Reflect What Was Done and reason Changes Were Made. The purpose of this study is to determine (1) if a specific breathing treatment (intermittent hypoxia) can promote changes in breathing function and (2) if pairing breathing treatments (hypoxia) with locomotor training can enhance the benefits of walking… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Brown Sequard, Central Cord Syndrome
- What is being tested?
- Intermittent Hypoxia and Locomotor Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 18 years of age
- At least 12 months post-incomplete spinal cord injury (I-SCI), including but not limited to the following syndromes: Brown Sequard and Central Cord Syndromes
- Upper motor neuron lesion (with upper motor neuron signs (i.e. presence of clonus, spasms, and/or hyperreflexia))
- A diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
- Resting oxygen saturation (SpO2) levels of 95-99%
- Individuals who ambulate independently, with an assistive device, or who can walk when provided manual assistance
Show all 9Show fewer
- Persons using anti-spasticity medication must maintain stable medication dosage during the study
- Able to give informed consent.
- Medical approval by individual's physician
Who cannot join
- Current participation in a rehabilitation program/research protocol that could interfere or influence the outcome measures of the current study
- History of congenital SCI (e.g. myelomeningocele, intraspinal neoplasm, Frederich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration, syringomyelia) that may complicate the protocol
- Inappropriate or unsafe fit of the harness due to the participant's body size and/or joint contractures or severe spasticity that would prohibit the safe provision of either training modality.
- Severe spasticity that would prohibit the safe provision of training.
- Pregnancy - all women of childbearing age will be required to undergo pregnancy testing prior to enrollment
- Unstable medical condition that could interfere with safety during participation in study (i.e. symptomatic cardiopulmonary complication, osteoporosis, contractures or other significant medical complications that would prohibit or interfere with testing of walking function and training or alter compliance with a training protocol)
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
Official title: Intermittent Hypoxia and Locomotor Training: Effects Following SCI
Change to Reflect What Was Done and reason Changes Were Made.
The purpose of this study is to determine (1) if a specific breathing treatment (intermittent hypoxia) can promote changes in breathing function and (2) if pairing breathing treatments (hypoxia) with locomotor training can enhance the benefits of walking recovery observed with locomotor training alone (without breathing treatments).
Read the detailed description
Spinal cord injury (SCI) is a very disabling health problem. Paralysis and paresis of limb and trunk muscles are major consequences of SCI and result in the inability to walk or difficulty walking. The most commonly stated goal by individuals with SCI during rehabilitation is the desire to walk again. Locomotor training (LT) that uses a body-weight support system and treadmill (BWST) is a task-specific rehabilitation intervention that allows practice of walking at normal speeds while loading the lower extremities, facilitating upright posture, and hip extension. Substantial improvement in ambulation can occur following locomotor training (LT) in individuals with motor incomplete spinal cord injury (iSCI). Despite these advances in activity-dependent rehabilitation, a need exists for defining complementary strategies that further amplify endogenous neuroplasticity. The proposed study will assess the therapeutic potential of (1) a respiratory training intervention (acute intermittent hypoxia, or AIH) on breathing function and (2) a combined locomotor (LT) and respiratory (AIH) training intervention for enhancing walking recovery.
- Conditions
- Spinal Cord Injuries, Brown Sequard, Central Cord Syndrome
- Being tested
- Intermittent Hypoxia, Locomotor Training
- Keywords
- Respiration, Spinal cord injuries, Walking recovery
- Medical subject headings
- Spinal Cord Injuries, Central Cord Syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent HypoxiaOther
Also called Breathing Treatment
Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.
Locomotor TrainingOther
Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Arm (Pilot) | Experimental | Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc) Receives: Other: Intermittent Hypoxia; Other: Locomotor Training |
| Phase 2 Arm (LTF) | Experimental | Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation Receives: Other: Intermittent Hypoxia |
| Phase 3 Arm (Ventilatory Loading) | Other | Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading. Receives: Other: Intermittent Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minute Ventilation - Phase 2
Minute ventilation (Ve) is the volume of gas inhaled or exhaled from a person's lungs per minute. Minute ventilation during the end-recovery (ER) period at initial (i.e., Days 1 and 2, initial ER period) and final (i.e., Days 9 and 10, final ER period) days of the IH protocol were normalized to values from baseline with elevated carbon dioxide (B2) within each individual session to characterize daily effects of exposure to IH at the beginning and end of treatment. Values from baseline with elevated carbon dioxide and the ER period during the final days of the protocol (final B2 and final ER period, respectively) also were normalized to elevated carbon dioxide baseline during initial days of the protocol (initial B2) to describe the cumulative effects of repeated exposure to IH. Outcomes are reported as % increases in minute ventilation during initial and final treatment sessions for daily/acute effects and cumulative/chronic effects.
Measured: Pre- versus Post-treatment
Secondary outcomes (1)
Ventilatory Loading - Phase 3
Ventilatory load compensation was assessed in two ways. Mean slopes for (1) pressure vs. resistance (P vs R) and (2) airflow vs. resistance (AF vs R) were calculated for pre- and post-IH treatment.
Measured: Pre- versus Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startMay 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Florida, Wayne State University
- Responsible party
- Sponsor
- Investigators
- Nicole J Tester, PhD, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272011
- Sponsor's protocol ID
- B7182-W
- Status last verified
- Feb 2016
- First submitted
- 5 Jan 2011
- Last updated
- 29 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tester NJ, Fuller DD, Fromm JS, Spiess MR, Behrman AL, Mateika JH. Long-term facilitation of ventilation in humans with chronic spinal cord injury. Am J Respir Crit Care Med. 2014 Jan 1;189(1):57-65. doi: 10.1164/rccm.201305-0848OC.
PubMed 24224903
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Hypoxia and Locomotor Training: Effects Following SCI
- ClinicalTrials.gov ID
- NCT01272011
- Acronym / sponsor ID
- B7182-W
- Conditions
- Spinal Cord Injuries, Brown Sequard, Central Cord Syndrome
- Keywords
- Respiration, Spinal cord injuries, Walking recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Florida, Wayne State University
- Study start
- May 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Posted 29 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Change to Reflect What Was Done and reason Changes Were Made.
The purpose of this study is to determine (1) if a specific breathing treatment (intermittent hypoxia) can promote changes in breathing function and (2) if pairing breathing treatments (hypoxia) with locomotor training can enhance the benefits of walking recovery observed with locomotor training alone (without breathing treatments).
Detailed description
Spinal cord injury (SCI) is a very disabling health problem. Paralysis and paresis of limb and trunk muscles are major consequences of SCI and result in the inability to walk or difficulty walking. The most commonly stated goal by individuals with SCI during rehabilitation is the desire to walk again. Locomotor training (LT) that uses a body-weight support system and treadmill (BWST) is a task-specific rehabilitation intervention that allows practice of walking at normal speeds while loading the lower extremities, facilitating upright posture, and hip extension. Substantial improvement in ambulation can occur following locomotor training (LT) in individuals with motor incomplete spinal cord injury (iSCI). Despite these advances in activity-dependent rehabilitation, a need exists for defining complementary strategies that further amplify endogenous neuroplasticity. The proposed study will assess the therapeutic potential of (1) a respiratory training intervention (acute intermittent hypoxia, or AIH) on breathing function and (2) a combined locomotor (LT) and respiratory (AIH) training intervention for enhancing walking recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Arm (Pilot) | Experimental | Other: Intermittent Hypoxia, Other: Locomotor TrainingIndividuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc) |
| Phase 2 Arm (LTF) | Experimental | Other: Intermittent HypoxiaIndividuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation |
| Phase 3 Arm (Ventilatory Loading) | Other | Other: Intermittent HypoxiaIndividuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults at least 18 years of age
- At least 12 months post-incomplete spinal cord injury (I-SCI), including but not limited to the following syndromes: Brown Sequard and Central Cord Syndromes
- Upper motor neuron lesion (with upper motor neuron signs (i.e. presence of clonus, spasms, and/or hyperreflexia))
- A diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
- Resting oxygen saturation (SpO2) levels of 95-99%
Key exclusion criteria (6 listed)
- Current participation in a rehabilitation program/research protocol that could interfere or influence the outcome measures of the current study
- History of congenital SCI (e.g. myelomeningocele, intraspinal neoplasm, Frederich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration, syringomyelia) that may complicate the protocol
- Inappropriate or unsafe fit of the harness due to the participant's body size and/or joint contractures or severe spasticity that would prohibit the safe provision of either training modality.
- Severe spasticity that would prohibit the safe provision of training.
- Pregnancy - all women of childbearing age will be required to undergo pregnancy testing prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent HypoxiaAlso: Breathing TreatmentIndividuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days. | Other | Phase 1 Arm (Pilot), Phase 2 Arm (LTF), Phase 3 Arm (Ventilatory Loading) |
| Locomotor TrainingIndividuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns. | Other | Phase 1 Arm (Pilot) |
Primary outcome
Minute Ventilation - Phase 2
Time frame: Pre- versus Post-treatment
Minute ventilation (Ve) is the volume of gas inhaled or exhaled from a person's lungs per minute. Minute ventilation during the end-recovery (ER) period at initial (i.e., Days 1 and 2, initial ER period) and final (i.e., Days 9 and 10, final ER period) days of the IH protocol were normalized to values from baseline with elevated carbon dioxide (B2) within each individual session to characterize daily effects of exposure to IH at the beginning and end of treatment. Values from baseline with elevated carbon dioxide and the ER period during the final days of the protocol (final B2 and final ER period, respectively) also were normalized to elevated carbon dioxide baseline during initial days of the protocol (initial B2) to describe the cumulative effects of repeated exposure to IH. Outcomes are reported as % increases in minute ventilation during initial and final treatment sessions for daily/acute effects and cumulative/chronic effects.
1 secondary outcome
Ventilatory Loading - Phase 3
Time frame: Pre- versus Post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24224903Tester NJ, Fuller DD, Fromm JS, Spiess MR, Behrman AL, Mateika JH. Long-term facilitation of ventilation in humans with chronic spinal cord injury. Am J Respir Crit Care Med. 2014 Jan 1;189(1):57-65. doi: 10.1164/rccm.201305-0848OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole J Tester, PhD principal investigator
North Florida/South Georgia Veterans Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Hypoxia and Locomotor Training in people with Spinal Cord Injuries and Brown Sequard, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minute Ventilation - Phase 2 (time frame: Pre- versus Post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01272011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.