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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-session 10 (up to two weeks) for reporting.

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 more

Trial 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.

Do I qualify?Apply below to find out