Clinical trial NCT04699474: Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury
Official title: Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury (PROMPT-SCI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Hopital du Sacre-Coeur de Montreal
Sponsor class: OTHER
Collaborators: name: University of Louisville
name: Université de Montréal
name: The Craig H. Neilsen Foundation
name: École de technologie supérieure
First posted: 2021-01-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Ambulation
timeFrame: 6 months
Secondary outcomes:
measure: Neurological recovery
timeFrame: 6 months
measure: Function
timeFrame: 6 months
measure: Spasticity
timeFrame: 6 months
measure: Health related quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
Study officials:
affiliation: Hopital du Sacre-Coeur de Montreal
name: Jean-Marc Mac-Thiong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.