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

NCT07472985 | Recruiting

• 2 other identifiers: 2025-2972525255
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord injuries (SCI) are among the most catastrophic survivable events experienced by human beings. Affected individuals remain with lifelong neurological impairment involving motor, sensory, bladder and bowel functions, which in turn impacts quality of life and independence. Currently, patients have no access to exercise therapy for weeks to months after the injury because clinicians remain fearful that early initiation of exercise therapy may be harmful to patients, and could lead to neurological deterioration. Patients are therefore mostly immobilized during the first weeks after the injury, and are at high risk of complications associated with immobility. In addition, there are compelling preclinical evidence showing that early exercise therapy is effective for promoting neurofunctional recovery. The PROMPT-SCI trial was the first to initiate early exercise therapy in the form of in-bed leg cycling within days after SCI. This trial has shown that it is safe and does not lead to neurological deterioration. However, in-bed leg cycling remains difficult to translate into the clinical environment of acute SCI, and its potential to decrease complications and improve neurofunctional recovery seems limited by the positioning in bed. The PROMPT-SCI II trial will therefore evaluate the potential of sitting leg cycling initiated within the first week of a SCI to decrease complications and improve neurofunctional recovery up to one year after the injury, in comparison to our prior data obtained with early in-bed cycling.

Conditions

Spinal Cord Injuries; Spinal Cord Injury (SCI), Initial Encounter

Keywords

spinal cord injury; exercise; activity-based therapy; rehabilitation; complications; acute care; critical care; neuroplasticity

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  Adverse events including changes in blood pressure, heart rate, oxygen saturation, etc.

  perioperatively/periprocedurally

• Complications

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

  perioperatively/periprocedurally

Secondary Outcomes (11)

• Score from Item 14 of the Spinal Cord Independence Measure ranging from 0 to 8

  1 year

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

  1 year

• Total score of Spinal Cord Independence Measure ranging from 0 to 100

  1 year

• Frequence of spasms from Penn Spasm Frequency Scale ranging from 0 to 4

  1 year

• Spasticity severity from Spinal Cord Assessment Tool for Spastic Reflexes ranging from 0 to 3

  1 year

Study Arms (1)

activity-based therapy

EXPERIMENTAL

leg cycling

Procedure: activity-based therapy

Interventions

activity-based therapy PROCEDURE

Daily 30-minute sessions of seated cycling throughout acute care

activity-based therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults 18 years or older with non-penetrating traumatic SCI
• SCI severity AIS grade A (complete injury with no motor or sensory function below lesion), B (sensory but no motor function preserved) or C (motor function preserved with most key muscles unable to move against gravity)
• NLI between C0 and L2; and spine surgery performed within 48 hours of SCI

You may not qualify if:

• 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
• hemodynamic instability
• pelvic or lower extremity
• injury with weight-bearing or mobilization restrictions

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J1C5, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Jean-Marc Mac-Thiong, MD, PhD

  Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Marc Mac-Thiong, MD, PhD

CONTACT

514-338-2222; jean-marc.mac-thiong@umontreal.ca

Andreane Richard-Denis, MD, MSc

CONTACT

514-338-2222; andreane.rdenis@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 16, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): August 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)