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

Sponsor
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Study ID
NCT07472985
Status
Recruiting
Apply to this trial

Conditions

  • Spinal Cord Injuries
  • Spinal Cord Injury (SCI), Initial Encounter

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • activity-based therapy — PROCEDURE
    Daily 30-minute sessions of seated cycling throughout acute care

Study Details

Spinal cord injuries (SCI) are among the most catastrophic survivable events experienced by human beings. Affected individuals remain with lifelong neurological impairment involving motor, sensory, bladder and bowel functions, which in turn impacts quality of life and independence. Currently, patients have no access to exercise therapy for weeks to months after the injury because clinicians remain fearful that early initiation of exercise therapy may be harmful to patients, and could lead to neurological deterioration. Patients are therefore mostly immobilized during the first weeks after the injury, and are at high risk of complications associated with immobility. In addition, there are compelling preclinical evidence showing that early exercise therapy is effective for promoting neurofunctional recovery. The PROMPT-SCI trial was the first to initiate early exercise therapy in the form of in-bed leg cycling within days after SCI. This trial has shown that it is safe and does not lead to neurological deterioration. However, in-bed leg cycling remains difficult to translate into the clinical environment of acute SCI, and its potential to decrease complications and improve neurofunctional recovery seems limited by the positioning in bed. The PROMPT-SCI II trial will therefore evaluate the potential of sitting leg cycling initiated within the first week of a SCI to decrease complications and improve neurofunctional recovery up to one year after the injury, in comparison to our prior data obtained with early in-bed cycling.

Key Dates

First listed
Mar 16, 2026
Start date
Mar 9, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
102 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: activity-based therapy
    leg cycling

Primary Outcome Measure

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: perioperatively/periprocedurally ]

Central Contacts

Related Studies