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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord Injury+1 MoreAcute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Session 1 (baseline test, initial visit), After 5 intervention sessions (Post Test), 1 week post (1 week follow up Post)

Week 1
Change in 10 Meter Walk Test
Change in 6 Minute Walk Test
Timed Up and Go Test: Assesses mobility, balance, walking ability and fall risk

Trial Safety

Trial Design

3 Treatment Groups

Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Trainin...
1 of 3
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Tr...
1 of 3
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Ga...
1 of 3

Experimental Treatment

Non-Treatment Group

36 Total Participants · 3 Treatment Groups

Primary Treatment: Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training · Has Placebo Group · N/A

Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Device
Experimental Group · 1 Intervention: Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training · Intervention Types: Device
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Other
ShamComparator Group · 1 Intervention: Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training · Intervention Types: Other
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
Other
ShamComparator Group · 1 Intervention: Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: session 1 (baseline test, initial visit), after 5 intervention sessions (post test), 1 week post (1 week follow up post)

Who is running the clinical trial?

University of California, Los AngelesOTHER
1,415 Previous Clinical Trials
6,763,231 Total Patients Enrolled
Shirley Ryan AbilityLabLead Sponsor
173 Previous Clinical Trials
13,666 Total Patients Enrolled
Arun Jayaraman, PT, PhDPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
21 Previous Clinical Trials
2,781 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The ASIA Impairment Scale, also known as the ASIA scale, is a measure of spinal cord injury severity
when they are adequately informed about the study People who participate in a study are able to provide informed consent if they are given enough information about the study
and have never been married People who are 18 years old or older and have never been married can take part in this study.
, This study found that participants who did not receive regular physical therapy services did not experience significant improvement in their condition.
by a physician People who have a spinal cord injury below the level of C2 have been diagnosed by a doctor.
People who have had a spinal cord injury for at least six months are allowed to participate in the study.
You have paraplegia or tetraplegia secondary to a single spinal cord injury.

Who else is applying?

What state do they live in?
Illinois100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Shirley Ryan AbilityLab100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%