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

Not Applicable

• Conditions: Spinal Cord Injuries
• Interventions: Device: Leg ergometer

• Registration Number: NCT04699474
• Lead Sponsor: Hopital du Sacre-Coeur de Montreal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Study Start: 2021-04-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early in-bed leg cycling	Leg ergometer	-

Primary Outcome Measures

Name	Time	Method
Ambulation	6 months	Independent walking (with or without device)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital du Sacre-Coeur de Montreal; 🇨🇦 Montréal, Quebec, Canada