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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04699474
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : August 25, 2021
Sponsor:
Collaborators:
University of Louisville
Université de Montréal
The Craig H. Neilsen Foundation
École de technologie supérieure
Information provided by (Responsible Party):
Jean-Marc Mac-Thiong, Hopital du Sacre-Coeur de Montreal

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Leg ergometer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury (PROMPT-SCI)
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Early in-bed leg cycling Device: Leg ergometer
Leg cycling in bed using motorized ergometer


Outcome Measures
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Primary Outcome Measures :
  1. Ambulation [ Time Frame: 6 months ]
    Independent walking (with or without device)


Secondary Outcome Measures :
  1. Neurological recovery [ Time Frame: 6 months ]
    International Standards for Neurological Classification of Spinal Cord Injury

  2. Function [ Time Frame: 6 months ]
    Spinal Cord Independence Measure

  3. Spasticity [ Time Frame: 6 months ]
    Spinal Cord Assessment Tool for Spastic Reflexes

  4. Health related quality of life [ Time Frame: 6 months ]
    Short-form 36 and World Health Organization Quality of Life - BREF


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699474


Contacts
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Contact: Jean-Marc Mac-Thiong, MD, PhD 514-338-2222 ext 7464 jean-marc.mac-thiong@umontreal.ca

Locations
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Canada, Quebec
Hopital du Sacre-Coeur de Montreal Recruiting
Montréal, Quebec, Canada, H4J1C5
Contact: Genevieve LeBlanc         
Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
University of Louisville
Université de Montréal
The Craig H. Neilsen Foundation
École de technologie supérieure
Investigators
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Principal Investigator: Jean-Marc Mac-Thiong, MD, PhD Hopital du Sacre-Coeur de Montreal
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jean-Marc Mac-Thiong, Principal Investigator, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT04699474    
Other Study ID Numbers: 2020-1901
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In line with the recommendations from the Committee on strategies for Responsible Sharing of Clinical Trial Data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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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
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System