102 Participants NeededMy employer runs this trial

Activity-Based Therapy for Spinal Cord Injury

(PROMPT-SCI II Trial)

JM
AR
Overseen ByAndreane 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 trial tests an early exercise therapy called Activity-Based Therapy, which uses a sitting leg cycling machine for individuals with spinal cord injuries. The researchers aim to determine if starting this exercise within the first week post-injury can reduce complications and improve recovery over the following year. Individuals who have experienced a non-penetrating spinal cord injury and underwent spine surgery within 48 hours may be suitable candidates for this trial. The goal is to enhance motor and sensory functions, as well as bladder and bowel control, often affected by such injuries. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could improve recovery outcomes for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this activity-based therapy is safe for spinal cord injury patients?

Research has shown that activity-based therapy (ABT) for spinal cord injuries is safe. One study found that starting ABT soon after a spinal cord injury, within a few days, did not cause serious problems, and participants tolerated it well. Another report indicated that patients in an ABT program rated it highly, with most giving scores of 8 out of 10 or higher. Evidence also suggests that ABT can improve independence and functional ability. This indicates that people generally tolerate the therapy well, and it does not cause harm.12345

Why are researchers excited about this trial?

Activity-based therapy is unique because it involves leg cycling, which directly stimulates the muscles and nerves below the site of the spinal cord injury. Unlike traditional rehabilitation methods that often focus on compensating for lost function, this therapy aims to reactivate and strengthen the neural pathways and muscles. Researchers are excited about this approach because it holds the potential to improve mobility and independence for individuals with spinal cord injuries by promoting natural, functional recovery.

What evidence suggests that activity-based therapy might be an effective treatment for spinal cord injury?

Research has shown that activity-based therapy (ABT), which participants in this trial will receive, can help people with spinal cord injuries (SCI) improve. Studies have found that intense physical therapy can boost mobility and function in those with SCI. Specifically, one study found that ABT improved sitting balance, movement, and quality of life for people with long-term SCI. Another study suggested that ABT can aid in walking and support nerve recovery. Overall, promising evidence indicates that ABT can enhance functional outcomes for people with SCI.26789

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 adults 18 or older who have had a recent, non-penetrating traumatic spinal cord injury (between neck and lower back), with severe movement or sensation loss. They must have had spine surgery within 48 hours of the injury.

Inclusion Criteria

My spinal cord injury is AIS grade A, B, or C.
I am 18 or older and have a non-penetrating spinal cord injury.
My spinal cord injury is between C0 and L2, and I had surgery within 48 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Acute Care and Treatment

Participants perform daily 30-minute sessions of seated cycling throughout acute care, starting as soon as they are fit for cycling

Up to 1 year
Daily sessions

Follow-up

Participants are monitored for neurofunctional recovery and complications up to 1 year post-SCI

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Activity-Based Therapy

Trial Overview

The study tests if starting sitting leg cycling exercise within the first week after spinal cord injury helps reduce complications and improve recovery over one year, compared to earlier in-bed cycling methods.

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+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Citations

Effectiveness of intense, activity-based physical therapy ... - PMC

This study provides encouraging evidence as to the effectiveness of intense PT for individuals with SCI.

A Scoping Review of the Characteristics of Activity-based ...

Activity-based therapy for recovery of walking in chronic spinal cord injury: results from a secondary analysis to determine responsiveness to therapy. Arch ...

Activity-Based Therapy for Mobility, Function and Quality of ...

Overall, we found that ABT led to small positive changes in sitting balance, mobility and quality of life in people with a chronic SCI. Furthermore, the ...

Effects of Activity-Based Therapy Interventions on Mobility ...

In conclusion, there is evidence that ABT can improve independence and functional ability when applied to the upper limbs in people with SCI. However, it is not ...

Systematic Review of Activity-Based Interventions to ...

This systematic review examined the literature to see if there is evidence to suggest that activity-based interventions can lead to neural recovery after SCI.

Implementing Activity-Based Therapy for Spinal Cord Injury ...

The purpose of our study was to examine the current state of ABT in Canadian healthcare settings according to users' perspectives.

Safety and efficacy of intensive task-specific training in ...

It is widely believed that intensive task-specific training enhances neurological recovery in people with spinal cord injury (SCI) by exploiting ...

Exploring knowledge and implementation gaps of activity ...

This study explored the existing knowledge, perceptions, and implementation of ABT among physical and occupational therapists working in non-SCI-specialized ...

Activity-Based Therapy for Mobility, Function and Quality of ...

Seven participants rated the program with a score of at least 8 out of 10; the eighth participant rated it between 6 and 7. All participants acknowledged the ...