Spinal Cord Injuries (SCI)
Conditions
Keywords
spinal cord injury, incomplete, Acute Intermittent Hypoxia
Brief summary
This study aims to evaluate how different doses of acute intermittent hypoxia (AIH) affect lower-limb strength, reaction time, and responsiveness in individuals with spinal cord injury (SCI). The objective is to identify the dose that most effectively improves motor output while also examining parameters that may account for variability in response.
Interventions
OTHERSham AIH
In this intervention, participants will wear a fitted mask, and will be given 15 bouts of room air through the same delivery system as the AIH interventions
OTHERAcute Intermittent Hypoxia (AIH) 15
In this intervention, participants will wear a fitted mask, and will be given 15, 60 second bouts of lowered oxygen (9% O2, akin to being on a tall mountain). Following the 60 seconds of hypoxia, participants will be given 60 seconds of room air
OTHERAcute Intermittent Hypoxia (AIH) 23
In this intervention, participants will wear a fitted mask, and will be given 23, 60 second bouts of lowered oxygen (9% O2, akin to being on a tall mountain). Following the 60 seconds of hypoxia, participants will be given 60 seconds of room air
Sponsors
Milap Sandhu
Shirley Ryan AbilityLab
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will not know if they are receiving AIH or Sham AIH
Intervention model description
Randomized, cross over design, participants will complete both arms
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic Spinal Cord Injury (\>6 months) * Motor incomplete SCI classified as AIS C or D * Volitional ankle plantarflexion strength in at least one leg
Exclusion criteria
* Uncontrolled hypertension (outside 140/90 and 90/60) * Concurrent medical illness * Traumatic brain injury * Cardiovascular complications * Pulmonary complications * Metabolic dysfunction * Continued use of anti-spasticity medications * Previously diagnosed obstructive sleep apnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ankle plantarflexion and dorsiflexion | Immediately following Intervention | Measurement of ankle force during a maximum voluntary contraction while pushing or pulling on a force plate |
| Lower Limb Reaction time | Immediately following intervention | Assessed using visual, auditory, and combined cueing tasks, reaction time will be quantified as the time from cue presentation to muscle activity onset |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 burden | During intervention | SpO2 data collected continuously throughout the hypoxic periods, defined as the area under the SpO2 time desaturation curve below a baseline threshold, this quantifies the cumulative hypoxic dose experienced |
| Hypoxic Ventilatory Response | During intervention | HVR will be assessed using breath-by-breath monitoring of ventilation via respiratory flow sensor or pneumotachograph during intervention. The relation between ventilation increases and the corresponding reduction SpO2 will quantify individual ventilatory responsiveness |
Countries
United States
Contacts
CONTACTMilap Sandhu, PhD, PT
PRINCIPAL_INVESTIGATORMilap Sandhu, PT, PhD
Shirley Ryan AbilityLab
Outcome results
None listed