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

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Leg ergometer

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4J1C5
      • Hopital du Sacre-Coeur de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Blunt traumatic spinal cord injury
• Neurological level of injury from C0 to L2
• American Spinal Injury Association impairment scale grade A, B or C
• Spine surgery performed within 48 hours of injury

Exclusion Criteria:

• Condition limiting patient's ability to engage into cycling
• Medical condition that might interfere with patient's safety if cycling
• Moderate or severe brain injury
• Inability to walk independently prior to injury
• Pre-existing neurological disorder
• Complete spinal cord transection
• Unwilling or unable to comply with scheduled follow-up

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: Early in-bed leg cycling	Device: Leg ergometer; Leg cycling in bed using motorized ergometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulation	Independent walking (with or without device)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological recovery	International Standards for Neurological Classification of Spinal Cord Injury	6 months
Function	Spinal Cord Independence Measure	6 months
Spasticity	Spinal Cord Assessment Tool for Spastic Reflexes	6 months
Health related quality of life	Short-form 36 and World Health Organization Quality of Life - BREF	6 months

Collaborators and Investigators

• Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
• Collaborators: University of Louisville; The Craig H. Neilsen Foundation; Université de Montréal; École de technologie supérieure
• Investigators: Principal Investigator: Jean-Marc Mac-Thiong, MD, PhD, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Publications and helpful links

General Publications

• Mac-Thiong JM, Richard-Denis A, Petit Y, Bernard F, Barthelemy D, Dionne A, Magnuson DSK. 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. BMJ Open. 2021 Nov 1;11(11):e049884. doi: 10.1136/bmjopen-2021-049884.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• 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: 2020-1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In line with the recommendations from the Committee on strategies for Responsible Sharing of Clinical Trial Data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes