NCT04699474: PROMPT-SCI

Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury

Completed NA Last updated 26 November 2025

What this trial tests

NA trial testing Leg ergometer in Spinal Cord Injuries in 45 participants. Completed in 31 August 2024.

Timeline

1 April 2021

Primary endpoint
31 July 2024

31 August 2024

Quick facts

Lead sponsor	Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	1 April 2021
Primary completion	31 July 2024
Estimated completion	31 August 2024
Sites	1 location across Canada

Drugs / interventions tested

• Leg ergometer

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal — full company profile →

Who can join

18 and older, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PROMPT-SCI (Protocol for Rapid Onset of Mobilization in Patients with Traumatic SCI) is a single-site single-arm proof-of-concept trial. Forty-five patients aged 18 years or older who have sustained a severe traumatic SCI (American Spinal Injury Association Impairment Scale grade A, B or C) from C0 to L1 and undergoing spinal surgery within 48 hours of the injury will be included. Participants will receive daily 30-minute sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours after spinal surgery. The feasibility outcomes consist of the 1) absence of serious adverse events associated with cycling sessions, 2) completion of at least 1 full session within 48 hours after spinal surgery for at least 90% of participants, and 3) completion of at least 11 sessions for at least 80% of participants. Patient outcomes 6 weeks and 6 months after injury will be measured from neurofunctional assessments, quality of life questionnaires and inpatient length of stay. Feasibility and patient outcomes will be analysed with descriptive statistics. Patient outcomes will also be compared to a matched historical cohort not receiving in-bed cycling.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Mac-Thiong JM, Richard-Denis A, Petit Y, Bernard F, et al · · 2021 · cited 6× · PMID 34725077 · DOI 10.1136/bmjopen-2021-049884
2. Is it safe to initiate activity-based therapy within days following traumatic spinal cord injury? Preliminary results from the PROMPT-SCI trial.
   Dionne A, Cavayas YA, Magnuson D, Richard-Denis A, et al · · 2023 · cited 4× · PMID 37531608 · DOI 10.1080/10790268.2023.2212329
3. Early exercise therapy in patients with severe traumatic spinal cord injury: is it feasible in the ICU?
   Dionne A, Magnuson D, Richard-Denis A, Petit Y, et al · · 2025 · cited 2× · PMID 40102964 · DOI 10.1186/s13054-025-05297-8
4. Effects of early acute in-bed leg cycling initiated from the intensive care unit following severe traumatic spinal cord injury: final results from the PROMPT-SCI trial.
   Dionne A, Magnuson DSK, Richard-Denis A, Bernard F, et al · · 2026 · PMID 41947246 · DOI 10.1186/s13054-026-06010-z