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

NCT04699474 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-11-26

No results posted yet for this study

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

Interventions

DEVICE

Leg ergometer

Leg cycling in bed using motorized ergometer

Sponsors & Collaborators

  • University of Louisville

    collaborator OTHER

  • Université de Montréal

    collaborator OTHER

  • The Craig H. Neilsen Foundation

    collaborator OTHER

  • École de technologie supérieure

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Jean-Marc Mac-Thiong, MD, PhD · Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2024-07-31
Completion
2024-08-31
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04699474 on ClinicalTrials.gov