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Procedure

Acute Intermittent Hypoxia + Non-Invasive Spinal Cord Stimulation + Gait Training for Spinal Cord Injury

N/A
Recruiting
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)
Awards & highlights

Study 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
  • Spinal Cord Injury
  • Spinal Cord Disease

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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and session 1 (baseline test, initial visit), after 5 intervention sessions (post test), 1 week post (1 week follow up post) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 6 Minute Walk Test
Secondary outcome measures
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
192 Previous Clinical Trials
14,849 Total Patients Enrolled
University of California, Los AngelesOTHER
1,528 Previous Clinical Trials
10,276,815 Total Patients Enrolled
Arun Jayaraman, PT, PhDPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
22 Previous Clinical Trials
2,866 Total Patients Enrolled

Media Library

Spinal Cord Injury Research Study Groups: Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training, Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training, Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for potential participants in this investigation?

"Affirmative. Clinicaltrials.gov data shows that this experiment is actively in search of subjects, with the first posting being on December 1st 2020 and a recent update occurring on October 24th 2022. 36 participants are needed to be recruited from one site for the trial's completion."

Answered by AI

What is the maximum capacity of people who can participate in this clinical trial?

"Affirmative. The clinicaltrials.gov registry reflects that this research study, which was first made public on December 1st 2020, is actively seeking participants. 36 individuals are expected to be enrolled from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Shirley Ryan AbilityLab
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training
Arun Jayaraman, PT, PhD 2020. "SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03922802.
~8 spots leftby Apr 2025
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