Acute Intermitted Hypoxia for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord InjuryAcute Intermitted Hypoxia - Other
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial will investigate whether combining daily hypoxia therapy with massed practice training can improve upper-body function in people with chronic incomplete cervical spinal cord injuries.

Eligible Conditions
  • Spinal Cord Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: up to 3 months

up to 3 months
GRASSP

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Rapael glove with Sham dAIH
1 of 5
Rapael glove with dAIH
1 of 5
Massed practice training with dAIH
1 of 5
Massed practice training with Sham dAIH
1 of 5
No training with dAIH
1 of 5

Active Control

Experimental Treatment

Non-Treatment Group

125 Total Participants · 5 Treatment Groups

Primary Treatment: Acute Intermitted Hypoxia · Has Placebo Group · N/A

Rapael glove with dAIHExperimental Group · 2 Interventions: Rapael Glove, Acute Intermitted Hypoxia · Intervention Types: Other, Other
Massed practice training with dAIHExperimental Group · 2 Interventions: Acute Intermitted Hypoxia, Massed Practise · Intervention Types: Other, Procedure
Massed practice training with Sham dAIHExperimental Group · 2 Interventions: Acute Intermitted Hypoxia, Massed Practise · Intervention Types: Other, Procedure
No training with dAIH
Other
PlaceboComparator Group · 1 Intervention: Acute Intermitted Hypoxia · Intervention Types: Other
Rapael glove with Sham dAIHActiveComparator Group · 2 Interventions: Rapael Glove, Acute Intermitted Hypoxia · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 months

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
173 Previous Clinical Trials
13,577 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
An individual must have experienced their injury at least 6 months ago if it was traumatic in nature
Be able to voluntarily activate your hand muscles and score a 2 or higher on one of the GRASSP assessment's grasp patterns (cylindrical grasp, lateral key pinch, or tip to tip pinch)
If you are pregnant or nursing, consult your doctor before taking any supplements.
This person has a spinal cord injury that has not gotten better over time
Between the ages of 18 and 75.
The ability to understand and willingness to sign an informed consent are both necessary in order to participate in a clinical trial.
An evaluation of strength showed that there was a significant increase in strength following a single bout of AIH.
If you have been diagnosed with any of the following medical conditions: 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, you are not a candidate for transesophageal echocardiography.
Individuals who have a tracheostomy or who use mechanical ventilation.
People who are currently enrolled in another research study on upper extremity function or who are in therapy related to upper extremity function.