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Intermittent Hypoxia Therapy for Spinal Cord Injury

N/A
Recruiting
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
Lesion at or below C2 and above T12 with non-progressive etiology
Classified as motor-incomplete with visible volitional leg movement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks)
Awards & highlights

Study Summary

This trial will test if repeatedly breathing low oxygen levels for brief periods can help people with chronic spinal cord injuries to recover some motor function.

Who is the study for?
This trial is for adults aged between 18 and 75 with a chronic spinal cord injury, who can still move their legs voluntarily. They must have had the injury for over a year and be medically cleared to participate. The injury should be non-progressive and located between C2 and T12 on the spine.Check my eligibility
What is being tested?
The study tests whether breathing low oxygen levels in short bursts (intermittent hypoxia) can improve limb movement and enhance nerve pathways in people with chronic spinal cord injuries. It also includes walking exercises and strength training as part of the therapy being examined.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from low oxygen such as headache or dizziness, fatigue from physical exercises, or muscle soreness after strength training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My spinal injury is between my neck and upper back and is not getting worse.
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I can move my legs on my own.
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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two 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 muscle strength
Change in overground walking endurance
Secondary outcome measures
Change in overground walking speed

Trial Design

2Treatment groups
Active Control
Group I: AIH/StrengthActive Control2 Interventions
Subjects with chronic, motor-incomplete SCI receive AIH with strength practice, then AIH with walking practice and compare their efficacy on enhancing strength and/or walking performance.
Group II: AIH/WalkActive Control2 Interventions
Subjects with chronic, motor-incomplete SCI receive acute intermittent hypoxia (AIH) with walking practice, then AIH with strength practice and compare their efficacy on enhancing strength and/or walking performance.

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Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,697 Total Patients Enrolled
Spaulding Rehabilitation HospitalLead Sponsor
134 Previous Clinical Trials
10,971 Total Patients Enrolled
Foundation Wings For LifeOTHER
13 Previous Clinical Trials
1,185 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 this clinical research endeavor accept aged individuals above the age of eighty?

"This study has established age restrictions to ensure safe participation – applicants must be 18 years old or older, yet not past the age of 75."

Answered by AI

How many people may partake in this investigation?

"Yes, the clinicaltrials.gov portal states that this medical trial is currently recruiting participants. It was first released on October 1st 2014 and has been updated as recently as June 24th 2022. This study seeks 44 patients from one site in particular."

Answered by AI

Are there any slots available for participants in this experiment?

"Affirmative. According to the clinicaltrials.gov website, this study is open for recruitment and was first posted on October 1st 2014 with a most recent update of June 24th 2022. The trial is looking for 44 individuals from one specific site to participate in the research project."

Answered by AI

Who would be a viable candidate for participating in this trial?

"This trial is seeking to enrol 44 patients aged between 18 and 75 who suffer from spinal cord injuries. Patient eligibility requires them to be medically cleared for participation, have a lesion at or below C2 and above T12 with non-progressive roots, classified as motor-incomplete with visible volitional leg movement, and an injury of greater than one year in duration."

Answered by AI
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~0 spots leftby May 2024