Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury III (PROMPT-SCI III) Trial

MI-összefoglaló

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The trial is looking for adults with a mild spinal cord injury caused by an accident or trauma. They must have had spine surgery within 48 hours of the injury. Participants do daily seated cycling during their hospital stay.

Életkor

18 years or older

Nem

All sexes

A betegség stádiuma

Mild, incomplete traumatic spinal cord injury that did not pierce the body (non-penetrating). Severity AIS grade D: most key muscles can still move against gravity. Injury level between C0 and L2.

Korábbi kezelés

Spine surgery must have been done within 48 hours of the injury.

A részvétel fő kizáró okai

• Needing a breathing tube and a breathing machine
• Moderate or severe traumatic brain injury
• Unstable blood pressure or circulation
• Body mass index 40 kg/m2 or less, as the record states
• Pelvic or leg injury that limits weight-bearing or movement, or other conditions that make cycling unsafe

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat csoportja

• Activity-based therapyA vizsgált kezelés

  Participants will receive daily 30-minute continuous sessions of leg cycling in seated position throughout acute care, starting after surgery as soon as the patient is fit for cycling. While the participant is seated in the armchair in the hospital room, a motorized under desk exerciser will be placed on the floor so that the feet are positioned comfortably on the pedals. The exerciser will be positioned to ensure that maximal knee flexion during cycling will be 70 degrees. Pedal straps are installed to secure the feet while pedaling. Running shoes are provided to participants to prevent harmful pressure and/or friction on heels, and the risk of developing pressure injuries. Participants will pedal at a target cadence of 40 revolutions per minute (RPM).Unless participants actively reach the target cadence of 40 RPM, motor assistance will be noted and titrated/adjusted by the research assistant until the target is reached.

  Kezelés: Cycling