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

Spinal Cord Injuries Clinical Trial

— PROMPT-SCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699474
• Other study ID #: 2020-1901
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2021
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: Jean-Marc Mac-Thiong, MD, PhD
• Phone: 514-338-2222
• Email: jean-marc.mac-thiong[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Leg ergometer
Leg cycling in bed using motorized ergometer

Locations

Country	Name	City	State
Canada	Hopital du Sacre-Coeur de Montreal	Montréal	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal	École de technologie supérieure, The Craig H. Neilsen Foundation, Université de Montréal, University of Louisville

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulation	Independent walking (with or without device)	6 months
Secondary	Neurological recovery	International Standards for Neurological Classification of Spinal Cord Injury	6 months
Secondary	Function	Spinal Cord Independence Measure	6 months
Secondary	Spasticity	Spinal Cord Assessment Tool for Spastic Reflexes	6 months
Secondary	Health related quality of life	Short-form 36 and World Health Organization Quality of Life - BREF	6 months