Cycling for Spinal Cord Injury

(PROMPT-SCI III Trial)

JM
AR
Overseen ByAndreane Richard-Denis Richard-Denis, MD, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This longitudinal cohort study will investigate the clinical benefits of early acute exercise therapy after mild spinal cord injury (SCI). The hypothesis is that early acute exercise therapy after mild SCI will improve neurofunctional recovery (walking, functional independence, motor and sensory recovery) and quality of life one year after the SCI, while decreasing complications during acute care and reducing the care burden (shorter hospital stay and home discharge more likely). For this study, 107 participants with mild SCI will be recruited. Participants will perform daily 30-minute sessions of seated cycling throughout acute care, starting within 2 days of their surgery to decompress the spinal cord. Neurofunctional recovery, quality of life, acute complications and care burden for the participants performing early acute cycling will be compared to a control cohort of patients with mild SCI who did not receive exercise therapy during acute care.

Who Is on the Research Team?

JM

Jean-Marc Mac-Thiong, MD, PhD

Principal Investigator

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Are You a Good Fit for This Trial?

This trial is for people who have recently had a mild spinal cord injury and surgery to relieve pressure on their spine. Participants must be able to start exercise therapy within 2 days after surgery.

Inclusion Criteria

I am 18 or older and have a non-penetrating spinal cord injury.
My spinal cord injury is AIS grade D, and I can move most key muscles against gravity.
My spinal cord injury is between C0 and L2, and I had surgery within 48 hours.

Exclusion Criteria

Body mass index 40 kg/m2 or less to prevent 'frog leg' position during cycling
Conditions interfering with patient safety or ability to undergo cycling
I have unstable blood pressure or heart function.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Cycling

Trial Overview

The study tests if starting daily seated cycling exercises soon after mild spinal cord injury helps with walking, independence, nerve recovery, and quality of life compared to those who don't do this early exercise.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Activity-based therapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Lead Sponsor

Trials
17
Recruited
4,600+