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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adults 18 years or older with non-penetrating traumatic SCI

SCI severity AIS grade D (motor function preserved with most key muscles able to move against gravity)

NLI between C0 and L2; and spine surgery performed within 48 hours of SCI

Disqualifiers

intubated and mechanically ventilated

conditions interfering with patient safety or ability to undergo cycling

body mass index 40 kg/m2 or less (to prevent "frog leg" position during cycling)

moderate or severe traumatic brain injury

Trial design

Design model

Single group

Treatments tested in this trial

  • Cycling

    Device

    Seated cycling using motorized under desk exerciser

Treatment groups

107 Participants
are divided into 1 treatment group
Group A: Activity-based therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Score from Item 14 of the Spinal Cord Independence Measure ranging from a minimum of 0 to a maximum of 8 (a higher score means a better outcome)

Ambulation in the community

Time frame
1 year

Secondary outcomes

1

Complications

Acute complications including pneumonia, urinary tract infection, pressure injury, spasticity, etc.

Time frame
perioperatively/periprocedurally
2

Presence or absence of an improvement by one American Spinal Injury Association Impairment Scale grade from baseline to 1 year

Difference in American Spinal Injury Association Impairment Scale grade between baseline and 1 year

Time frame
1 year
3

Total score of Spinal Cord Independence Measure ranging from a minimum of 0 to a maximum of 100 (a higher score means a better outcome)

Functional independence

Time frame
1 year
4

Frequence of spasms from Penn Spasm Frequency Scale ranging from a minimum of 0 to a maximum of 4 (a higher score means a worse outcome)

Severity of spasticity

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: