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Intermittent Hypoxia Therapy for Spinal Cord Injury

N/A
Waitlist Available
Led By Randy D Trumbower, PT, PhD
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Those classified as ambulatory must have the ability to advance one step overground without human assistance
Motor---incomplete SCI at C2---L5 with non---progressive etiology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks
Awards & highlights

Study Summary

This trial will test the effects of acute intermittent hypoxia on leg muscle strength, reflexes, and walking in people with incomplete cervical spinal cord injury.

Who is the study for?
This trial is for adults aged 18-75 with incomplete spinal cord injury from C2-L5, medically stable and able to take a step without help. It's been over 6 months since their injury. People can't join if they have heart or lung issues, are in physical therapy, have severe pain or infections, fractures due to osteoporosis, leg nerve damage, cognitive impairment (score <24 on Mini-Mental), are pregnant or at risk of frequent autonomic dysreflexia.Check my eligibility
What is being tested?
The study tests how low oxygen periods (AIH) affect leg muscle control and strength in people with cervical spinal cord injuries compared to normal air breathing (SHAM). The goal is to see if AIH improves voluntary leg strength, reflexes in the legs, and walking ability.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing a mask for gas delivery and risks associated with brief low oxygen levels such as lightheadedness or fainting. However specific side effect details aren't provided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can walk and take a step without help from another person.
Select...
I have a spinal cord injury that is not getting worse, between my neck and lower back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks 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 overground walking endurance
Secondary outcome measures
Change in overground walking speed

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intermittent Hypoxia (AIH)Active Control1 Intervention
Subjects with chronic, motor-incomplete SCI will breath mild bouts of low oxygen. Intervention: AIH - Intermittent Hypoxia - hypoxia air mixture Dosage: 10% oxygen Frequency: 1.5 minutes bouts of low oxygen with 1.0 minute intervals of room air Duration: 38 minutes
Group II: Intermittent Room Air (SHAM)Placebo Group1 Intervention
Subjects with chronic, motor-incomplete SCI will breath mild bouts of room air. Intervention: SHAM - Intermittent Room Air - room air mixture Dosage: 21% oxygen Frequency: 1.5 minutes bouts of room air with 1.0 minute intervals also of room air Duration: 38 minutes

Find a Location

Who is running the clinical trial?

Foundation Wings For LifeOTHER
13 Previous Clinical Trials
1,199 Total Patients Enrolled
Spaulding Rehabilitation HospitalLead Sponsor
134 Previous Clinical Trials
10,985 Total Patients Enrolled
Randy D Trumbower, PT, PhDPrincipal InvestigatorSpaulding Rehabilitation Hospital
5 Previous Clinical Trials
192 Total Patients Enrolled

Frequently Asked Questions

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

Does the trial encompass participants above senior age?

"To be considered for this trial, patients must fall between 18 and 75 years of age. Those under the legal consenting age have 175 other trials to choose from while those older than 65 can look at 825 potential options."

Answered by AI

Are there any available vacancies for participation in this medical trial?

"Affirmative, the information presented on clinicaltrials.gov illustrates that this experiment is presently inviting participants to join. Its initial posting was October 1st 2014 and its most recent edit occurred June 24th 2022; 20 individuals are necessary from one study site."

Answered by AI

What is the total participant capacity for this clinical trial?

"Correct. According to clinicaltrials.gov, this medical research project which was published on October 1st 2014 is currently recruiting patients. Only 20 people are needed to be enrolled in the study at a single location."

Answered by AI

Is there an eligibility criteria for volunteers to join this research?

"This medical study is admitting 20 individuals, aged 18 to 75 years old, who suffer from spinal cord injuries. To be eligible for the trial, patients must meet additional criteria such as being medically stable with a doctor's approval; having an incomplete SCI at C2---L5 due to non-progressive origins; and experiencing their injury more than 6 months prior in order to reduce confounding factors of natural recovery. Additionally, ambulatory participants are required to demonstrate the capacity to take one step overground independently."

Answered by AI
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~0 spots leftby May 2024