Activity-Based Therapy for Spinal Cord Injury
(PROMPT-SCI II Trial)
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for neurofunctional recovery and complications up to 1 year post-SCI
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
leg cycling
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
Canadian Institutes of Health Research (CIHR)
Collaborator
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 ...
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