Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06521723

Low Oxygen Therapy to Enhance Walking Recovery After SCI.

Led by Spaulding Rehabilitation Hospital · Updated on 2026-03-20

60

Participants Needed

2

Research Sites

173 weeks

Total Duration

On this page

Sponsors

S

Spaulding Rehabilitation Hospital

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury of different age groups.

CONDITIONS

Official Title

Low Oxygen Therapy to Enhance Walking Recovery After SCI.

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 to 80 years of age
  • Medically stable with clearance from study physician
  • Spinal cord injury at or below C1 and at or above L2 with some sensory or motor function preserved below the injury
  • Non-progressive spinal injury
  • ASIA scores of C-D at initial screening
  • Able to complete 10-meter walk test without support
  • Chronic injury more than 12 months post-injury
Not Eligible

You will not qualify if you...

  • Severe illness or pain including unhealed wounds, severe neuropathic or chronic pain, severe infections, hypertension, cardiovascular or pulmonary disease, severe osteoporosis, active heterotopic ossification, or systemic inflammation
  • Mini-Mental Exam score less than 24
  • Severe recurrent autonomic dysreflexia
  • History of severe cardiovascular or pulmonary complications including hypertension with systolic blood pressure over 150 mmHg
  • Pregnancy
  • Botulinum toxin injections in lower extremity muscles within prior 3 months
  • History of tendon or nerve transfer surgery in lower extremities
  • Untreated severe sleep-disordered breathing with uncontrolled hypoxia
  • Active implanted devices such as intrathecal baclofen pump
  • Receiving concurrent electrical stimulation
  • Motor threshold evoked by transcutaneous spinal stimulation over 200 mA

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Brooks Rehabilitation Hospital

Jacksonville, Florida, United States, 32216

Actively Recruiting

2

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, United States, 02128

Actively Recruiting

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Research Team

N

Noah Piazza

CONTACT

R

Randy Trumbower, PT, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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