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

NCT04699474 | Completed DMC FDA Device

• 1 other identifier: 2020-1901
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Ambulation

  Independent walking (with or without device)

  6 months

Secondary Outcomes (4)

• Neurological recovery

  6 months

• Function

  6 months

• Spasticity

  6 months

• Health related quality of life

  6 months

Study Arms (1)

Early in-bed leg cycling

EXPERIMENTAL

Device: Leg ergometer

Interventions

Leg ergometer DEVICE

Leg cycling in bed using motorized ergometer

Early in-bed leg cycling

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• University of Louisville: collaborator
• Université de Montréal: collaborator
• The Craig H. Neilsen Foundation: collaborator
• École de technologie supérieure: collaborator

Study Sites (1)

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J1C5, Canada

Location

Related Publications (1)

• 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.

  PMID: 34725077 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

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

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: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: April 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CA (1)