Protocol for rapid onset of mobilisation in patients with traumatic spinal cord injury (PROMPT-SCI) study: a single-arm proof-of-concept trial of early in-bed leg cycling following acute traumatic spinal cord injury

BMJ Open, 2021 · DOI: 10.1136/bmjopen-2021-049884 · Published: September 9, 2021

Simple Explanation

This study explores if early activity-based therapy (ABT), specifically in-bed leg cycling, can help patients with traumatic spinal cord injuries (SCI). ABT involves repetitive movements to stimulate the nervous system and potentially improve recovery. The study will involve patients with severe SCI who will undergo daily in-bed leg cycling sessions within 48 hours of spinal surgery. Researchers will monitor the feasibility and safety of this early intervention. The researchers will compare the outcomes of patients receiving early cycling with those of a matched historical cohort that did not receive this intervention, to see if there is any improvement in neurofunctional recovery, quality of life, and length of hospital stay.

Study Duration

6 Months

Participants

45 patients with severe traumatic SCI

Evidence Level

Single-arm proof-of-concept trial

Key Findings

1
The primary goal is to determine if early in-bed leg cycling can increase the likelihood of patients recovering independent walking ability 6 months after their injury.
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The study also aims to assess secondary outcomes such as neurological recovery, functional status, spasticity, quality of life, and inpatient length of stay.
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The study will monitor the feasibility of early in-bed leg cycling by tracking adverse events, completion rates of cycling sessions, and adherence to the study protocol.

Research Summary

This protocol outlines a single-arm proof-of-concept trial (PROMPT-SCI) to evaluate the feasibility and benefits of early activity-based therapy (ABT) in the form of in-bed leg cycling for patients with traumatic spinal cord injury (SCI). The study will recruit 45 patients with severe SCI who will receive daily in-bed leg cycling sessions within 48 hours after spinal surgery. Outcomes will be compared to a matched historical cohort. The primary outcome is the recovery of independent walking ability at 6 months post-injury. Secondary outcomes include neurological recovery, functional status, quality of life, and inpatient length of stay.

Practical Implications

Clinical Practice

If proven feasible and beneficial, early in-bed leg cycling could become a standard part of acute SCI care, potentially improving patient outcomes and reducing hospital stay.

Research

The results of this study will inform the design of a larger, multicenter randomized controlled trial to confirm the benefits of early in-bed leg cycling.

Patient Care

Early mobilization through in-bed cycling has the potential to decrease the rate of secondary complications associated with immobilization, such as pneumonias and thromboembolism.

Study Limitations

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Single-center study
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Findings need to be interpreted rigorously
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Protocol may not be readily applicable to other countries or healthcare systems

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