AIH in combination with upper extremity training for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord Injuries+2 More
Upper extremity training/Armeo Spring - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will investigate the effect of Acute Intermittent Hypoxia (AIH), in combination with upper extremity training, over the course of a month, to evaluate changes in upper extremity function, dexterity, and ability to complete activities of daily living in individuals with chronic incomplete spinal cord injuries.

Eligible Conditions
  • Spinal Cord Injuries

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 4 weeks

4 weeks
9-hole peg test
GRASSP
grip strength

Trial Safety

Trial Design

4 Treatment Groups

AIH in combination with upper extremity training
1 of 4
Acute Intermittent Hypoxia (AIH) treatment
1 of 4
Sham AIH therapy in combination with upper extremity training
1 of 4
Sham AIH therapy
1 of 4
Active Control

92 Total Participants · 4 Treatment Groups

Primary Treatment: AIH in combination with upper extremity training · No Placebo Group · Phase < 1

AIH in combination with upper extremity training
CombinationProduct
ActiveComparator Group · 1 Intervention: Upper extremity training/Armeo Spring · Intervention Types: CombinationProduct
Acute Intermittent Hypoxia (AIH) treatmentNoIntervention Group · 1 Intervention: Acute Intermittent Hypoxia (AIH) treatment · Intervention Types:
Sham AIH therapy in combination with upper extremity training
CombinationProduct
ActiveComparator Group · 1 Intervention: Upper extremity training/Armeo Spring · Intervention Types: CombinationProduct
Sham AIH therapyNoIntervention Group · 1 Intervention: Sham AIH therapy · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
170 Previous Clinical Trials
13,283 Total Patients Enrolled
48 Trials studying Spinal Cord Injuries
4,638 Patients Enrolled for Spinal Cord Injuries

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had a knee injury for at least 6 months.
You have a non-progressive spinal cord injury, inclusive of levels of C1-T1.
The cause of spinal cord injury is non-progressive in nature.
You must be tested for anemia with a value of at least 10g/dl (for both men and women).
Blood pressure must fall within this range.
You are able to demonstrate some hand muscle activation, or use of a tenodesis grasp (wrist extension).
Patients will be recommended to their primary care physician to correct anemia if low levels are detected.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.