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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries, Incomplete
• Intervention / Treatment: Device: Cycling

Detailed Description

GOALS: This longitudinal cohort study will investigate the clinical benefits of early acute exercise therapy after mild spinal cord injury (SCI).

Primary hypothesis: Recovering independent walking 1 year after a mild SCI is more likely with early acute exercise therapy, in comparison with a historical cohort not exposed to early acute exercise therapy. An increase in the percentage of individuals recovering independent walking in the community from 35% to 55% will be considered as a clinically meaningful increase.

Secondary hypothesis: Acute complications, neurological recovery, functional independence, quality of life and care pathway are improved with early acute exercise therapy.

METHODS: For this 5-year study, 107 participants with mild acute traumatic 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. The immediate response to cycling will be monitored from physiological (hemodynamic and respiratory) and electrophysiological (electromyography and H-reflex testing in lower extremities) assessments. Independent walking in the community (primary outcome) is defined by the ability to walk 100 meters outdoors without technical aids or only with leg orthosis. Secondary outcomes include all complications occurring during acute care (particularly early spasticity, pneumonia, urinary tract infection and pressure injury) and the care pathway (discharge destination and length of stay), as well as neurological recovery, functional independence and quality of life 1 year after the SCI. Outcomes will be compared to a control cohort of patients with mild SCI who did not receive exercise therapy during acute care, and the association with electrophysiological measures will be assessed.

• Study Type: Interventional
• Enrollment (Estimated): 107
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Marc Mac-Thiong, MD, PhD; Phone Number: 1+514-338-2222; Email: jean-marc.mac-thiong@umontreal.ca
• Study Contact Backup: Name: Andreane Richard-Denis Richard-Denis, MD, MSc; Phone Number: 1+514-338-2222; Email: andreane.rdenis@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, h4j1c5
      • Hopital Du Sacre-Coeur de Montreal
      • Contact: Lara Chawa; Phone Number: 1+514-338-2222; Email: lara.chawa.cnmtl@ssss.gouv.qc.ca
      • Principal Investigator: Jean-Marc Mac-Thiong, MD, PhD
      • Principal Investigator: Andreane Richard-Denis, MD, MSc

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 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

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; 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.

Device: Cycling; Seated cycling using motorized under desk exerciser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Acute complications including pneumonia, urinary tract infection, pressure injury, spasticity, etc.	perioperatively/periprocedurally
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
Presence or absence of neuropathic pain	International Spinal Cord Injury Pain Basic Data Set	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
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	1 year
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	1 year
Physical component score from Short-form 36 ranging from a minimum of 0 to a maximum of 100 (a higher score means a better outcome)	Physical component of Health-related quality of life	1 year
Mental component score from Short-form 36 ranging from a minimum of 0 to a maximum of 100 (a higher score means a better outcome)	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
• 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): September 1, 2026
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): January 31, 2031

Study Registration Dates

• First Submitted: August 27, 2026
• First Submitted That Met QC Criteria: August 27, 2026
• First Posted (Actual): September 1, 2026

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; spinal cord injury; exercise therapy; 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; Spinal Cord Injuries
• Other Study ID Numbers: ciusss-nordmtl

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