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Spinal Cord InjuriesPROMPT-SCINCT04699474

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

A study testing Leg ergometer in people with Spinal Cord Injuries, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Leg ergometer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteCanada
Study dates
1 Apr 2021to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J1C5

Other trials in Canada

About this study

Official title: Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury (PROMPT-SCI)

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.

Being tested
Leg ergometer
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.

  • Leg ergometerDevice

    Leg cycling in bed using motorized ergometer

Study groups in NCT04699474
Study groupRoleWhat they receive
Early in-bed leg cyclingExperimentalNot described
Receives: Device: Leg ergometer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ambulation

    Independent walking (with or without device)

    Measured: 6 months

Secondary outcomes (4)

  1. Neurological recovery

    International Standards for Neurological Classification of Spinal Cord Injury

    Measured: 6 months

  2. Function

    Spinal Cord Independence Measure

    Measured: 6 months

  3. Spasticity

    Spinal Cord Assessment Tool for Spastic Reflexes

    Measured: 6 months

  4. Health related quality of life

    Short-form 36 and World Health Organization Quality of Life - BREF

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2021
  2. Study start1 Apr 2021
  3. Primary completion31 Jul 2024
  4. Study completion31 Aug 2024

Resources

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
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04699474
Sponsor's protocol ID
2020-1901
Acronym
PROMPT-SCI
Status last verified
Nov 2025
First submitted
5 Jan 2021
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: In line with the recommendations from the Committee on strategies for Responsible Sharing of Clinical Trial Data

Publications

  • Dionne A, Magnuson DSK, Richard-Denis A, Bernard F, Barthelemy D, Petit Y, Mac-Thiong JM. Effects of early acute in-bed leg cycling initiated from the intensive care unit following severe traumatic spinal cord injury: final results from the PROMPT-SCI trial. Crit Care. 2026 Apr 7;30(1):267. doi: 10.1186/s13054-026-06010-z.

    PubMed 41947246

  • 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.

    PubMed 34725077

Questions about this trial

What is this clinical trial studying?

A study testing Leg ergometer in people with Spinal Cord Injuries, 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 4 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: finished, as of the sponsor's last update on 26 Nov 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ambulation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04699474, which also lists 2 linked publications.

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 26 Nov 2025.

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