Spinal Cord Injuries, IncompletePROMPT-SCI IIINCT07798310
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury III (PROMPT-SCI III) Trial
A study testing Cycling in people with Spinal Cord Injuries, Incomplete, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
This longitudinal cohort study will investigate the clinical benefits of early acute exercise therapy after mild spinal cord injury (SCI). The hypothesis is that early acute exercise therapy after mild SCI will improve neurofunctional recovery (walking, functional independence, motor and sensory recovery) and quality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Incomplete
- What is being tested?
- Cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 31 Jan 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 D (motor function preserved with most key muscles able 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
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, h4j1c5
Lara Chawa, 1+514-338-2222, lara.chawa.cnmtl@ssss.gouv.qc.ca
Jean-Marc Mac-Thiong, MD, PhD
About this study
This longitudinal cohort study will investigate the clinical benefits of early acute exercise therapy after mild spinal cord injury (SCI). The hypothesis is that early acute exercise therapy after mild SCI will improve neurofunctional recovery (walking, functional independence, motor and sensory recovery) and quality of life one year after the SCI, while decreasing complications during acute care and reducing the care burden (shorter hospital stay and home discharge more likely). For this study, 107 participants with mild SCI will be recruited. Participants will perform daily 30-minute sessions of seated cycling throughout acute care, starting within 2 days of their surgery to decompress the spinal cord. Neurofunctional recovery, quality of life, acute complications and care burden for the participants performing early acute cycling will be compared to a control cohort of patients with mild SCI who did not receive exercise therapy during acute care.
Read the detailed description
GOALS: This longitudinal cohort study will investigate the clinical benefits of early acute exercise therapy after mild spinal cord injury (SCI).
Primary hypothesis: Recovering independent walking 1 year after a mild SCI is more likely with early acute exercise therapy, in comparison with a historical cohort not exposed to early acute exercise therapy. An increase in the percentage of individuals recovering independent walking in the community from 35% to 55% will be considered as a clinically meaningful increase.
Secondary hypothesis: Acute complications, neurological recovery, functional independence, quality of life and care pathway are improved with early acute exercise therapy.
METHODS: For this 5-year study, 107 participants with mild acute traumatic SCI will be recruited. Participants will perform daily 30-minute sessions of seated cycling throughout acute care, starting within 2 days of their surgery to decompress the spinal cord. The immediate response to cycling will be monitored from physiological (hemodynamic and respiratory) and electrophysiological (electromyography and H-reflex testing in lower extremities) assessments. Independent walking in the community (primary outcome) is defined by the ability to walk 100 meters outdoors without technical aids or only with leg orthosis. Secondary outcomes include all complications occurring during acute care (particularly early spasticity, pneumonia, urinary tract infection and pressure injury) and the care pathway (discharge destination and length of stay), as well as neurological recovery, functional independence and quality of life 1 year after the SCI. Outcomes will be compared to a control cohort of patients with mild SCI who did not receive exercise therapy during acute care, and the association with electrophysiological measures will be assessed.
- Conditions
- Spinal Cord Injuries, Incomplete
- Being tested
- Cycling
- Keywords
- spinal cord injury, activity-based therapy, exercise therapy, rehabilitation, acute care
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclingDevice
Seated cycling using motorized under desk exerciser
| Study group | Role | What they receive |
|---|---|---|
| Activity-based therapy | Experimental | Participants will receive daily 30-minute continuous sessions of leg cycling in seated position throughout acute care, starting after surgery as soon as the patient is fit for cycling. While the participant is seated in the armchair in the hospital room, a motorized under desk exerciser will be placed on the floor so that the feet are positioned comfortably on the pedals. The exerciser will be positioned to ensure that maximal knee flexion during cycling will be 70 degrees. Pedal straps are installed to secure the feet while pedaling. Running shoes are provided to participants to prevent harmful pressure and/or friction on heels, and the risk of developing pressure injuries. Participants will pedal at a target cadence of 40 revolutions per minute (RPM).Unless participants actively reach the target cadence of 40 RPM, motor assistance will be noted and titrated/adjusted by the research assistant until the target is reached. Receives: Device: Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score from Item 14 of the Spinal Cord Independence Measure ranging from a minimum of 0 to a maximum of 8 (a higher score means a better outcome)
Ambulation in the community
Measured: 1 year
Secondary outcomes (10)
Complications
Acute complications including pneumonia, urinary tract infection, pressure injury, spasticity, etc.
Measured: perioperatively/periprocedurally
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 a minimum of 0 to a maximum of 100 (a higher score means a better outcome)
Functional independence
Measured: 1 year
Frequence of spasms from Penn Spasm Frequency Scale ranging from a minimum of 0 to a maximum of 4 (a higher score means a worse outcome)
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 a minimum of 0 to a maximum of 100 (a higher score means a better outcome)
Physical component of Health-related quality of life
Measured: 1 year
Mental component score from Short-form 36 ranging from a minimum of 0 to a maximum of 100 (a higher score means a better outcome)
Mental 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Jan 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 Injuries, IncompleteStudies 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
- Model description
- Prospective longitudinal cohort study
- Masking
- None (open label)
- Enrolment
- 107 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
- 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
- NCT07798310
- Sponsor's protocol ID
- ciusss-nordmtl
- Acronym
- PROMPT-SCI III
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 2 Sep 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 2 Sep 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 III (PROMPT-SCI III) Trial
- ClinicalTrials.gov ID
- NCT07798310
- Acronym / sponsor ID
- PROMPT-SCI III / ciusss-nordmtl
- Conditions
- Spinal Cord Injuries, Incomplete
- Keywords
- spinal cord injury, activity-based therapy, exercise therapy, rehabilitation, acute care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 1 Sep 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.
This longitudinal cohort study will investigate the clinical benefits of early acute exercise therapy after mild spinal cord injury (SCI). The hypothesis is that early acute exercise therapy after mild SCI will improve neurofunctional recovery (walking, functional independence, motor and sensory recovery) and quality of life one year after the SCI, while decreasing complications during acute care and reducing the care burden (shorter hospital stay and home discharge more likely). For this study, 107 participants with mild SCI will be recruited. Participants will perform daily 30-minute sessions of seated cycling throughout acute care, starting within 2 days of their surgery to decompress the spinal cord. Neurofunctional recovery, quality of life, acute complications and care burden for the participants performing early acute cycling will be compared to a control cohort of patients with mild SCI who did not receive exercise therapy during acute care.
Detailed description
GOALS: This longitudinal cohort study will investigate the clinical benefits of early acute exercise therapy after mild spinal cord injury (SCI).
Primary hypothesis: Recovering independent walking 1 year after a mild SCI is more likely with early acute exercise therapy, in comparison with a historical cohort not exposed to early acute exercise therapy. An increase in the percentage of individuals recovering independent walking in the community from 35% to 55% will be considered as a clinically meaningful increase.
Secondary hypothesis: Acute complications, neurological recovery, functional independence, quality of life and care pathway are improved with early acute exercise therapy.
METHODS: For this 5-year study, 107 participants with mild acute traumatic SCI will be recruited. Participants will perform daily 30-minute sessions of seated cycling throughout acute care, starting within 2 days of their surgery to decompress the spinal cord. The immediate response to cycling will be monitored from physiological (hemodynamic and respiratory) and electrophysiological (electromyography and H-reflex testing in lower extremities) assessments. Independent walking in the community (primary outcome) is defined by the ability to walk 100 meters outdoors without technical aids or only with leg orthosis. Secondary outcomes include all complications occurring during acute care (particularly early spasticity, pneumonia, urinary tract infection and pressure injury) and the care pathway (discharge destination and length of stay), as well as neurological recovery, functional independence and quality of life 1 year after the SCI. Outcomes will be compared to a control cohort of patients with mild SCI who did not receive exercise therapy during acute care, and the association with electrophysiological measures will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective longitudinal cohort study
| Arm | Type | Receives |
|---|---|---|
| Activity-based therapy | Experimental | Device: CyclingParticipants will receive daily 30-minute continuous sessions of leg cycling in seated position throughout acute care, starting after surgery as soon as the patient is fit for cycling. While the participant is seated in the armchair in the hospital room, a motorized under desk exerciser will be placed on the floor so that the feet are positioned comfortably on the pedals. The exerciser will be positioned to ensure that maximal knee flexion during cycling will be 70 degrees. Pedal straps are installed to secure the feet while pedaling. Running shoes are provided to participants to prevent harmful pressure and/or friction on heels, and the risk of developing pressure injuries. Participants will pedal at a target cadence of 40 revolutions per minute (RPM).Unless participants actively reach the target cadence of 40 RPM, motor assistance will be noted and titrated/adjusted by the research assistant until the target is reached. |
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 D (motor function preserved with most key muscles able 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 |
|---|---|---|
| CyclingSeated cycling using motorized under desk exerciser | Device | Activity-based therapy |
Primary outcome
Score from Item 14 of the Spinal Cord Independence Measure ranging from a minimum of 0 to a maximum of 8 (a higher score means a better outcome)
Time frame: 1 year
Ambulation in the community
10 secondary outcomes
Complications
Time frame: perioperatively/periprocedurally
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 a minimum of 0 to a maximum of 100 (a higher score means a better outcome)
Time frame: 1 year
Frequence of spasms from Penn Spasm Frequency Scale ranging from a minimum of 0 to a maximum of 4 (a higher score means a worse outcome)
Time frame: 1 year
Presence or absence of neuropathic pain
Time frame: 1 year
Physical component score from Short-form 36 ranging from a minimum of 0 to a maximum of 100 (a higher score means a better outcome)
Time frame: 1 year
Mental component score from Short-form 36 ranging from a minimum of 0 to a maximum of 100 (a higher score means a better outcome)
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
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 2 Sep 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 Cycling in people with Spinal Cord Injuries, Incomplete, 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: opening soon, as of the sponsor's last update on 2 Sep 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 (1+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?
Score from Item 14 of the Spinal Cord Independence Measure ranging from a minimum of 0 to a maximum of 8 (a higher score means a better outcome) (time frame: 1 year). 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 2 Sep 2026.