Spinal Cord InjuriesPROMPT-SCI IINCT07472985
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial
A study testing activity-based therapy in people with Spinal Cord Injuries and Spinal Cord Injury (SCI), Initial Encounter, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Injury (SCI), Initial Encounter
- What is being tested?
- activity-based therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- 9 Mar 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults 18 years or older with non-penetrating traumatic SCI
- SCI severity AIS grade A (complete injury with no motor or sensory function below lesion), B (sensory but no motor function preserved) or C (motor function preserved with most key muscles unable to move against gravity)
- NLI between C0 and L2; and spine surgery performed within 48 hours of SCI
Who cannot join
- intubated and mechanically ventilated
- conditions interfering with patient safety or ability to undergo cycling
- body mass index 40 kg/m2 or less (to prevent "frog leg" position during cycling)
- moderate or severe traumatic brain injury
- hemodynamic instability
- pelvic or lower extremity
- injury with weight-bearing or mobilization restrictions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J1C5
Lara Chawa, 514-338-2050, lara.chawa.cnmtl@ssss.gouv.qc.ca
About this study
Official title: Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial: Initiating Early Acute Cycling Within the First Days After Spinal Cord Injury to Decrease Complications and Improve Neurofunctional Recovery
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.
Read the detailed description
BACKGROUND: A severe traumatic spinal cord injury (SCI) leads to permanent sensorimotor neurological deficits. During acute care, patients are mostly immobilized due to pain (from injuries and surgeries) and inherent paralysis from the SCI, resulting in complications such as pneumonia, pressure injuries, deconditioning, etc. There is also compelling preclinical evidence showing that early immobilization after SCI impairs the capacity of the nervous system to reorganize and promote neurological recovery. The PROMPT-SCI trial was the first to perform a clinical trial of early acute exercise therapy in the form of in-bed leg cycling starting within 5 days of a SCI, leading to these findings: 1) no adverse events associated with cycling, 2) decreased rates of complications, and 3) activation of paralyzed muscles triggered by cycling. Unfortunately, the PROMPT-SCI trial failed to demonstrate neurofunctional benefits similar to those observed in preclinical studies, potentially due to the short 2-week duration of the intervention, and to insufficient tactile and proprioceptive feedback in lower extremities with in-bed cycling, which could be circumvented by performing seated cycling throughout the entire acute care.
GOALS: This longitudinal cohort study will investigate the feasibility and clinical benefits of early acute seated cycling on neurofunctional recovery and complications. The hypotheses are:
H1: There will be no serious adverse events; 80% of participants will complete a first session within 5 days of the SCI and at least 80% of all planned sessions thereafter.
H2: Complication rates will be decreased for pneumonia, urinary tract infection and pressure injuries.
H3: Neurofunctional recovery will be improved 1 year after the SCI.
The specific aims are:
Aim 1: Assess the feasibility of performing early seated cycling throughout acute care.
Aim 2: Assess the complication rates and neurofunctional recovery up to 1 year post-SCI.
METHODS: For this 5-year study, 102 participants with severe acute traumatic SCI (paralyzed lower extremities without anti-gravity strength) will be recruited. Participants will perform daily 30-minute sessions of seated cycling throughout acute care, starting as soon as they are fit for cycling. Adherence to protocol, complications and neurofunctional recovery (motor/sensory recovery, functional independence, spasticity) will be assessed up to 1 year post-SCI. Neurophysiological and biomechanical responses to cycling will be assessed from electromyographic and plantar pressure measurements. Outcomes will be compared to our control cohort of patients with severe SCI who have not received exercise therapy. The association between neurophysiological/biomechanical responses and outcomes will be assessed.
- Being tested
- activity-based therapy
- Keywords
- spinal cord injury, exercise, activity-based therapy, rehabilitation, complications, acute care, critical care, neuroplasticity
- Medical subject headings
- Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activity-based therapyProcedure or surgery
Daily 30-minute sessions of seated cycling throughout acute care
| Study group | Role | What they receive |
|---|---|---|
| activity-based therapy | Experimental | leg cycling Receives: Procedure: activity-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Adverse events including changes in blood pressure, heart rate, oxygen saturation, etc.
Measured: perioperatively/periprocedurally
Complications
Acute complications including pneumonia, urinary tract infection, pressure injury, spasticity, etc.
Measured: perioperatively/periprocedurally
Secondary outcomes (11)
Score from Item 14 of the Spinal Cord Independence Measure ranging from 0 to 8
Ambulation in the community
Measured: 1 year
Presence or absence of an improvement by one American Spinal Injury Association Impairment Scale grade from baseline to 1 year
Difference in American Spinal Injury Association Impairment Scale grade between baseline and 1 year
Measured: 1 year
Total score of Spinal Cord Independence Measure ranging from 0 to 100
Functional independence
Measured: 1 year
Frequence of spasms from Penn Spasm Frequency Scale ranging from 0 to 4
Spasm frequency
Measured: 1 year
Spasticity severity from Spinal Cord Assessment Tool for Spastic Reflexes ranging from 0 to 3
Severity of spasticity
Measured: 1 year
Presence or absence of neuropathic pain
International Spinal Cord Injury Pain Basic Data Set
Measured: 1 year
Physical component score from Short-form 36 ranging from 0 to 100
Physical component of Health-related quality of life
Measured: 1 year
Presence or absence of improvement in motor score by 5 points from baseline to 1 year
Difference in motor score from baseline to 1 year
Measured: 1 year
Presence or absence of improvement in sensory scores by 10 points from baseline to 1 year
Difference in sensory scores between baseline and 1 year
Measured: 1 year
Presence or absence of improvement by 2 neurological levels of injury from baseline to 1 year
Difference in neurological level of injury between baseline and 1 year
Measured: 1 year
Mental component score from Short-form 36 ranging from 0 to 100
Mental component of Health-related quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start9 Mar 2026
- Primary completion31 Aug 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jean-Marc Mac-Thiong, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Jean-Marc Mac-Thiong, MD, PhD, Principal investigator, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472985
- Sponsor's protocol ID
- 2025-2972
- Other IDs
- 525255
- Acronym
- PROMPT-SCI II
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD collected for the study are not publicly available. However, IPD will be made available to others upon reasonable request, and with permission from our Ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial: Initiating Early Acute Cycling Within the First Days After Spinal Cord Injury to Decrease Complications and Improve Neurofunctional Recovery
- ClinicalTrials.gov ID
- NCT07472985
- Acronym / sponsor ID
- PROMPT-SCI II / 2025-2972
- Keywords
- spinal cord injury, exercise, activity-based therapy, rehabilitation, complications, acute care, critical care, neuroplasticity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 31 Aug 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND: A severe traumatic spinal cord injury (SCI) leads to permanent sensorimotor neurological deficits. During acute care, patients are mostly immobilized due to pain (from injuries and surgeries) and inherent paralysis from the SCI, resulting in complications such as pneumonia, pressure injuries, deconditioning, etc. There is also compelling preclinical evidence showing that early immobilization after SCI impairs the capacity of the nervous system to reorganize and promote neurological recovery. The PROMPT-SCI trial was the first to perform a clinical trial of early acute exercise therapy in the form of in-bed leg cycling starting within 5 days of a SCI, leading to these findings: 1) no adverse events associated with cycling, 2) decreased rates of complications, and 3) activation of paralyzed muscles triggered by cycling. Unfortunately, the PROMPT-SCI trial failed to demonstrate neurofunctional benefits similar to those observed in preclinical studies, potentially due to the short 2-week duration of the intervention, and to insufficient tactile and proprioceptive feedback in lower extremities with in-bed cycling, which could be circumvented by performing seated cycling throughout the entire acute care.
GOALS: This longitudinal cohort study will investigate the feasibility and clinical benefits of early acute seated cycling on neurofunctional recovery and complications. The hypotheses are:
H1: There will be no serious adverse events; 80% of participants will complete a first session within 5 days of the SCI and at least 80% of all planned sessions thereafter.
H2: Complication rates will be decreased for pneumonia, urinary tract infection and pressure injuries.
H3: Neurofunctional recovery will be improved 1 year after the SCI.
The specific aims are:
Aim 1: Assess the feasibility of performing early seated cycling throughout acute care.
Aim 2: Assess the complication rates and neurofunctional recovery up to 1 year post-SCI.
METHODS: For this 5-year study, 102 participants with severe acute traumatic SCI (paralyzed lower extremities without anti-gravity strength) will be recruited. Participants will perform daily 30-minute sessions of seated cycling throughout acute care, starting as soon as they are fit for cycling. Adherence to protocol, complications and neurofunctional recovery (motor/sensory recovery, functional independence, spasticity) will be assessed up to 1 year post-SCI. Neurophysiological and biomechanical responses to cycling will be assessed from electromyographic and plantar pressure measurements. Outcomes will be compared to our control cohort of patients with severe SCI who have not received exercise therapy. The association between neurophysiological/biomechanical responses and outcomes will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| activity-based therapy | Experimental | Procedure: activity-based therapyleg cycling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults 18 years or older with non-penetrating traumatic SCI
- SCI severity AIS grade A (complete injury with no motor or sensory function below lesion), B (sensory but no motor function preserved) or C (motor function preserved with most key muscles unable to move against gravity)
- NLI between C0 and L2; and spine surgery performed within 48 hours of SCI
Key exclusion criteria (7 listed)
- intubated and mechanically ventilated
- conditions interfering with patient safety or ability to undergo cycling
- body mass index 40 kg/m2 or less (to prevent "frog leg" position during cycling)
- moderate or severe traumatic brain injury
- hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activity-based therapyDaily 30-minute sessions of seated cycling throughout acute care | Procedure or surgery | activity-based therapy |
Primary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: perioperatively/periprocedurally
Adverse events including changes in blood pressure, heart rate, oxygen saturation, etc.
Complications
Time frame: perioperatively/periprocedurally
Acute complications including pneumonia, urinary tract infection, pressure injury, spasticity, etc.
11 secondary outcomes
Score from Item 14 of the Spinal Cord Independence Measure ranging from 0 to 8
Time frame: 1 year
Presence or absence of an improvement by one American Spinal Injury Association Impairment Scale grade from baseline to 1 year
Time frame: 1 year
Total score of Spinal Cord Independence Measure ranging from 0 to 100
Time frame: 1 year
Frequence of spasms from Penn Spasm Frequency Scale ranging from 0 to 4
Time frame: 1 year
Spasticity severity from Spinal Cord Assessment Tool for Spastic Reflexes ranging from 0 to 3
Time frame: 1 year
Presence or absence of neuropathic pain
Time frame: 1 year
Physical component score from Short-form 36 ranging from 0 to 100
Time frame: 1 year
Presence or absence of improvement in motor score by 5 points from baseline to 1 year
Time frame: 1 year
Presence or absence of improvement in sensory scores by 10 points from baseline to 1 year
Time frame: 1 year
Presence or absence of improvement by 2 neurological levels of injury from baseline to 1 year
Time frame: 1 year
Mental component score from Short-form 36 ranging from 0 to 100
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. The IPD collected for the study are not publicly available. However, IPD will be made available to others upon reasonable request, and with permission from our Ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Marc Mac-Thiong, MD, PhD principal investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing activity-based therapy in people with Spinal Cord Injuries and Spinal Cord Injury (SCI), Initial Encounter, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc Mac-Thiong, MD, PhD (514-338-2222, jean-marc.mac-thiong@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 (time frame: perioperatively/periprocedurally). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.