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Behavioural Intervention
dSHAM + Walking + dAIH for Spinal Cord Injury
N/A
Waitlist Available
Led By Randy 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-session 10 (up to two weeks)
Summary
This trial will help researchers understand if short, controlled episodes of low oxygen can help improve movement and leg strength for people who have recently suffered a spinal cord injury.
Who is the study for?
This trial is for adults aged 18-70 with a spinal cord injury between C3 (but sparing the phrenic nerve) and L5, who still have some motor function. They must be stable medically, 2-12 months post-injury, able to perform certain walking and mobility tests, and not pregnant or suffering from severe illnesses or pain.
What is being tested?
The study is testing whether mild breathing treatments with low oxygen levels can improve walking ability and leg strength in people who've had a spinal cord injury. Participants will receive daily sessions of either this treatment (dAIH) or a sham procedure (dSHAM).
What are the potential side effects?
Potential side effects may include discomfort due to low oxygen such as headache or shortness of breath during the hypoxia treatment. There's also a risk of increased blood pressure or heart rate changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-session 10 (up to two weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-session 10 (up to two weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in walking recovery, assessed by 10 meter walk test (10MWT)
Change in walking recovery, assessed by 6 minute walk test (6MWT)
Change in walking recovery, assessed by timed up-and-go (TUG) test
Secondary study objectives
Autonomic dysreflexia incidence rate
Change in pain severity
Change in spasticity
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Non-ambulatory - dAIHExperimental Treatment1 Intervention
Non-ambulatory subjects will be randomly assigned to receive 10 sessions of daily acute intermittent hypoxia (dAIH) 10 treatment visits at a frequency of 5 days each week for 2 weeks.
Group II: Ambulatory-WalkExperimental Treatment1 Intervention
Ambulatory subjects will be randomly assigned to 10 sessions of walking practice only for 5 consecutive sessions/week x 2 weeks.
Group III: Ambulatory - dAIH+WalkExperimental Treatment2 Interventions
Ambulatory subjects will be randomly assigned to receive 10 sessions of daily acute intermittent hypoxia (dAIH) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.
Group IV: Non-ambulatory - dSHAMPlacebo Group1 Intervention
Non-ambulatory subjects will be randomly assigned to receive 10 sessions of daily room air (dSHAM) 10 treatment visits at a frequency of 5 days each week for 2 weeks.
Group V: Ambulatory - dSHAM+WalkPlacebo Group2 Interventions
Ambulatory subjects will be randomly assigned to receive 10 sessions of daily room air (dSHAM) coupled with 60 minutes of walking practice at a frequency of 5 days each week for 2 weeks.
Find a Location
Who is running the clinical trial?
Spaulding Rehabilitation HospitalLead Sponsor
139 Previous Clinical Trials
10,963 Total Patients Enrolled
United States Department of DefenseFED
916 Previous Clinical Trials
334,592 Total Patients Enrolled
Randy Trumbower, PT, PhDPrincipal Investigator - Harvard Medical School (HMS and HSDM)
Spaulding Rehabilitation Hospital
3 Previous Clinical Trials
123 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have serious ongoing health issues or severe pain, such as unhealed bedsores, strong nerve pain, or serious bone or nerve problems in your legs.You have a spinal cord injury above the lower back with some movement still working below the injury.Your spinal injury is not getting worse.You have a spinal cord injury that is classified as AIS grade A-D.You have a severe type of sleep apnea that is not well controlled and causes low oxygen levels and interrupted sleep.You were injured 2 to 12 months ago.You must be between 18 and 70 years old.You scored less than 24 on a test that checks memory and thinking skills.You have severe autonomic dysreflexia.You have a history of heart or lung problems.This criterion involves a test called the 6-minute walk test (6MWT).You need to be able to walk for 10 meters.Your spinal injury is not getting worse.You have a spinal cord injury between your neck and lower back with some movement remaining below the injury.You must be able to perform a timed up-and-go (TUG) test.
Research Study Groups:
This trial has the following groups:- Group 1: Non-ambulatory - dAIH
- Group 2: Non-ambulatory - dSHAM
- Group 3: Ambulatory - dAIH+Walk
- Group 4: Ambulatory - dSHAM+Walk
- Group 5: Ambulatory-Walk
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT02632422 — N/A