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

Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial: Initiating Early Acute Cycling Within the First Days After Spinal Cord Injury to Decrease Complications and Improve Neurofunctional Recovery

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Spinal Cord Injury (SCI), Initial Encounter
• Intervention / Treatment: Procedure: activity-based therapy

Detailed Description

BACKGROUND: A severe traumatic spinal cord injury (SCI) leads to permanent sensorimotor neurological deficits. During acute care, patients are mostly immobilized due to pain (from injuries and surgeries) and inherent paralysis from the SCI, resulting in complications such as pneumonia, pressure injuries, deconditioning, etc. There is also compelling preclinical evidence showing that early immobilization after SCI impairs the capacity of the nervous system to reorganize and promote neurological recovery. The PROMPT-SCI trial was the first to perform a clinical trial of early acute exercise therapy in the form of in-bed leg cycling starting within 5 days of a SCI, leading to these findings: 1) no adverse events associated with cycling, 2) decreased rates of complications, and 3) activation of paralyzed muscles triggered by cycling. Unfortunately, the PROMPT-SCI trial failed to demonstrate neurofunctional benefits similar to those observed in preclinical studies, potentially due to the short 2-week duration of the intervention, and to insufficient tactile and proprioceptive feedback in lower extremities with in-bed cycling, which could be circumvented by performing seated cycling throughout the entire acute care.

GOALS: This longitudinal cohort study will investigate the feasibility and clinical benefits of early acute seated cycling on neurofunctional recovery and complications. The hypotheses are:

H1: There will be no serious adverse events; 80% of participants will complete a first session within 5 days of the SCI and at least 80% of all planned sessions thereafter.

H2: Complication rates will be decreased for pneumonia, urinary tract infection and pressure injuries.

H3: Neurofunctional recovery will be improved 1 year after the SCI.

The specific aims are:

Aim 1: Assess the feasibility of performing early seated cycling throughout acute care.

Aim 2: Assess the complication rates and neurofunctional recovery up to 1 year post-SCI.

METHODS: For this 5-year study, 102 participants with severe acute traumatic SCI (paralyzed lower extremities without anti-gravity strength) will be recruited. Participants will perform daily 30-minute sessions of seated cycling throughout acute care, starting as soon as they are fit for cycling. Adherence to protocol, complications and neurofunctional recovery (motor/sensory recovery, functional independence, spasticity) will be assessed up to 1 year post-SCI. Neurophysiological and biomechanical responses to cycling will be assessed from electromyographic and plantar pressure measurements. Outcomes will be compared to our control cohort of patients with severe SCI who have not received exercise therapy. The association between neurophysiological/biomechanical responses and outcomes will be assessed.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Marc Mac-Thiong, MD, PhD; Phone Number: 514-338-2222; Email: jean-marc.mac-thiong@umontreal.ca
• Study Contact Backup: Name: Andreane Richard-Denis, MD, MSc; Phone Number: 514-338-2222; Email: andreane.rdenis@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4J1C5
      • Recruiting
      • Hopital du Sacre-Coeur de Montreal
      • Contact: Lara Chawa; Phone Number: 514-338-2050; Email: lara.chawa.cnmtl@ssss.gouv.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: activity-based therapy; leg cycling	Procedure: activity-based therapy; Daily 30-minute sessions of seated cycling throughout acute care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score from Item 14 of the Spinal Cord Independence Measure ranging from 0 to 8	Ambulation in the community	1 year
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	1 year
Total score of Spinal Cord Independence Measure ranging from 0 to 100	Functional independence	1 year
Frequence of spasms from Penn Spasm Frequency Scale ranging from 0 to 4	Spasm frequency	1 year
Spasticity severity from Spinal Cord Assessment Tool for Spastic Reflexes ranging from 0 to 3	Severity of spasticity	1 year
Presence or absence of neuropathic pain	International Spinal Cord Injury Pain Basic Data Set	1 year
Physical component score from Short-form 36 ranging from 0 to 100	Physical component of Health-related quality of life	1 year
Presence or absence of improvement in motor score by 5 points from baseline to 1 year	Difference in motor score from baseline to 1 year	1 year
Presence or absence of improvement in sensory scores by 10 points from baseline to 1 year	Difference in sensory scores between baseline and 1 year	1 year
Presence or absence of improvement by 2 neurological levels of injury from baseline to 1 year	Difference in neurological level of injury between baseline and 1 year	1 year
Mental component score from Short-form 36 ranging from 0 to 100	Mental component of Health-related quality of life	1 year

Collaborators and Investigators

• Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Jean-Marc Mac-Thiong, MD, PhD, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Study record dates

Study Major Dates

• Study Start (Estimated): March 9, 2026
• Primary Completion (Estimated): August 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: critical care; exercise; rehabilitation; complications; neuroplasticity; spinal cord injury; acute care; activity-based therapy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Behavior; Spinal Cord Injuries; Motor Activity
• Other Study ID Numbers: 2025-2972; 525255 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD collected for the study are not publicly available. However, IPD will be made available to others upon reasonable request, and with permission from our Ethics committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No