Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/1/2018 |
| Start Date: | November 16, 2018 |
| End Date: | March 2023 |
| Contact: | Sneha Solanki, MSc |
| Email: | ssolanki02@sralab.org |
| Phone: | 312-238-3647 |
Currently, there are a variety of approaches utilized in attempts to improve upper extremity
function, including: traditional therapy, neuroprostheses, botulinum toxin injections, or
surgical interventions. In addition, regenerative and restorative therapies, such as:
epidural stimulation, functional electrical stimulation, and stem cell therapies, show
promise in animal models, but are not ready for clinical translation. Subsequently, there is
a clear need to develop new strategies that can stimulate spinal plasticity and strengthen
existing synaptic connections in order to maximize the benefits of training paradigms.
This study proposes the examine the effects of Acute Intermittent Hypoxia (AIH) in
combination with upper extremity training, over the course of a month, to evaluate changes in
upper extremity function, dexterity, and ability to complete activities of daily living. The
use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal
studies, to be an effective way of increasing spinal motor excitability and strengthening
residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced
oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen
levels (~21% inspired oxygen).
Previous publications demonstrate that AIH is a safe and effective intervention to modify
motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has
been shown to influence the activation in musculature, within 60-120 minutes of
administration. In addition, when coupling AIH with overground gait training, an increase in
functional endurance, as evaluated through the 6 minute walk test, and gait speed, as
evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic
training has been studied in healthy individuals and athletes; however, literature examining
the effect of a single bout of AIH on performance is limited.
function, including: traditional therapy, neuroprostheses, botulinum toxin injections, or
surgical interventions. In addition, regenerative and restorative therapies, such as:
epidural stimulation, functional electrical stimulation, and stem cell therapies, show
promise in animal models, but are not ready for clinical translation. Subsequently, there is
a clear need to develop new strategies that can stimulate spinal plasticity and strengthen
existing synaptic connections in order to maximize the benefits of training paradigms.
This study proposes the examine the effects of Acute Intermittent Hypoxia (AIH) in
combination with upper extremity training, over the course of a month, to evaluate changes in
upper extremity function, dexterity, and ability to complete activities of daily living. The
use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal
studies, to be an effective way of increasing spinal motor excitability and strengthening
residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced
oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen
levels (~21% inspired oxygen).
Previous publications demonstrate that AIH is a safe and effective intervention to modify
motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has
been shown to influence the activation in musculature, within 60-120 minutes of
administration. In addition, when coupling AIH with overground gait training, an increase in
functional endurance, as evaluated through the 6 minute walk test, and gait speed, as
evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic
training has been studied in healthy individuals and athletes; however, literature examining
the effect of a single bout of AIH on performance is limited.
This study proposes the examine the effects of Acute Intermittent Hypoxia (AIH) in
combination with upper extremity training, over the course of a month, to evaluate changes in
upper extremity function, dexterity, and ability to complete activities of daily living. The
use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal
studies, to be an effective way of increasing spinal motor excitability and strengthening
residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced
oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen
levels (~21% inspired oxygen).
Previous publications demonstrate that AIH is a safe and effective intervention to modify
motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has
been shown to influence the activation in musculature, within 60-120 minutes of
administration. In addition, when coupling AIH with overground gait training, an increase in
functional endurance, as evaluated through the 6 minute walk test, and gait speed, as
evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic
training has been studied in healthy individuals and athletes; however, literature examining
the effect of a single bout of AIH on performance is limited.
combination with upper extremity training, over the course of a month, to evaluate changes in
upper extremity function, dexterity, and ability to complete activities of daily living. The
use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal
studies, to be an effective way of increasing spinal motor excitability and strengthening
residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced
oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen
levels (~21% inspired oxygen).
Previous publications demonstrate that AIH is a safe and effective intervention to modify
motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has
been shown to influence the activation in musculature, within 60-120 minutes of
administration. In addition, when coupling AIH with overground gait training, an increase in
functional endurance, as evaluated through the 6 minute walk test, and gait speed, as
evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic
training has been studied in healthy individuals and athletes; however, literature examining
the effect of a single bout of AIH on performance is limited.
Inclusion Criteria:
- History of a non-progressive spinal cord injury, inclusive of levels of C3-T1.
- Etiology of spinal cord injury is non-progressive in nature
- Be able to demonstrate some hand muscle activation,
- At least 1 year post injury
- Ability to open and close at least one hand without assistance
- At least a 10% increase in isometric elbow flexion force above baseline, after a
single bout of Acute Intermittent Hypoxia (AIH), during first screening visit
- Participants do NOT have to stop taking antispasticity medications to participate in
the study.
- Must be tested for anemia with a value of at least 10g/dl (for both men and women).
- Patients will be recommended to their primary care physician to correct anemia if low
levels are detected
- Blood pressure must fall within this range- high: 160/110mmHg low: 85/55 mmHg
- Must be asymptomatic (no dizziness, lightheadedness, etc)
Exclusion Criteria:
- Medical conditions, including: congestive heart failure, cardiac arrhythmias,
uncontrolled hypertension, uncontrolled diabetes mellitus, chronic obstructive
pulmonary disease, emphysema, severe asthma, previous myocardial infraction, or known
carotid/intracerebral artery stenosis.
- Women who are currently pregnant or planning on becoming pregnant
- Current tracheostomy placement
- Utilization of mechanical ventilator for breathing
- Current diagnosis of obstructive sleep apnea
- Orthopedic injuries or surgeries that would limit participation
- Concurrent participation in another research study or therapy services
- Comorbid traumatic brain injury or other neurologic injuries that would impact
cognition
We found this trial at
1
site
355 East Erie Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: William Z Rymer, MD/PhD
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