High-Intensity Exercise for Spinal Cord Injury

Overseen By Thomas G Hornby, PT, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Intrathecal baclofen, Botulinum toxin

Disqualifiers: Obesity, Cardiovascular disease, Orthopedic bracing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 8 weeks

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to identify the comparative efficacy of high-intensity walking training in individuals with chronic, motor incomplete spinal cord injury as compared to lower-intensity walking exercise.

Who Is on the Research Team?

Thomas G Hornby

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with chronic motor incomplete spinal cord injury (AIS C or D), lasting more than a year, and lesions between C1-T10. They should be able to walk with minimal assistance and have normal range of motion in their legs. Excluded are those over 400 lbs, with certain health issues like unhealed wounds, heart disease, severe osteoporosis, lung diseases, or brain injuries.

Inclusion Criteria

I have a spinal cord injury between C1-T10 and can still move somewhat.

I have a spinal cord injury that is not fully paralyzing, lasting more than a year, between my neck and mid-back.

I can walk and move my ankles, knees, and hips within normal ranges.

Exclusion Criteria

You have a history of autonomic dysreflexia.

You weigh more than 400 pounds.

I cannot stand for 10 minutes without feeling dizzy or faint.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high or low intensity locomotor training for 2 months, consisting of 30 sessions of walking-related activities in variable contexts

8 weeks

30 sessions

Follow-up

Participants are monitored for changes in locomotor performance, cardiopulmonary capacity, and neuromuscular coordination

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Walking training

Trial Overview The study tests the effectiveness of high-intensity walking training versus lower-intensity exercise for people with chronic motor incomplete spinal cord injury. It aims to see which intensity level improves walking ability better.

How Is the Trial Designed?

Group I: High Intensity Locomotor Training Experimental Treatment 1 Intervention

High Intensity Locomotor Training will consist of 30 sessions of walking related activities in variable contexts (i..e, on a treadmill, overground, and on stairs), with a primary goal to achieve 40 minutes of walking within 1 hour sessions while achieving heart rates close to 80% of heart rate reserve.

Group II: Low Intensity Locomotor Training Active Control 1 Intervention

High Intensity Locomotor Training will consist of 30 sessions of walking related activities in variable contexts (i..e, on a treadmill, overground, and on stairs), with a primary goal to achieve 40 minutes of walking within 1 hour sessions while achieving heart rates from 30% to 40% of heart rate reserve.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Rehabilitation Hospital of Indiana

Collaborator

Trials

13

Recruited

5,500+