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Procedure
Acute Intermittent Hypoxia + Non-Invasive Spinal Cord Stimulation + Gait Training for Spinal Cord Injury
N/A
Waitlist Available
Led By Arun Jayaraman, PT, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up session 1 (baseline test, initial visit), after 5 intervention sessions (post test), 1 week post (1 week follow up post)
Summary
This trial will compare the effects of a sham therapy to a real therapy on gait and balance for people with spinal cord injuries.
Eligible Conditions
- Thoracic Myelopathy
- Cervical Disc Disorder
- Spinal Cord Injury
- Spinal Cord Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ session 1 (baseline test, initial visit), after 5 intervention sessions (post test), 1 week post (1 week follow up post)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~session 1 (baseline test, initial visit), after 5 intervention sessions (post test), 1 week post (1 week follow up post)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in 6 Minute Walk Test
Secondary study objectives
Change in 10 Meter Walk Test
Timed Up and Go Test: Assesses mobility, balance, walking ability and fall risk
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait TrainingExperimental Treatment1 Intervention
May receive up to 45 minutes of AIH prior to up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
Intervention: Device: AIH prior to Noninvasive spinal stimulation during gait training
Group II: Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait TrainingPlacebo Group1 Intervention
May receive up to 45 minutes of Sham AIH prior to up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
Group III: Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait TrainingPlacebo Group1 Intervention
May receive up to 45 minutes of Sham AIH prior to up to 50 min of locomotion training with sham transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
Find a Location
Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
206 Previous Clinical Trials
17,893 Total Patients Enrolled
University of California, Los AngelesOTHER
1,559 Previous Clinical Trials
10,258,835 Total Patients Enrolled
Arun Jayaraman, PT, PhDPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
23 Previous Clinical Trials
3,366 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
- Group 2: Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
- Group 3: Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
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