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| Name | Class |
|---|---|
| University of Louisville | OTHER |
| Université de Montréal | OTHER |
| The Craig H. Neilsen Foundation | OTHER |
| École de technologie supérieure |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early in-bed leg cycling | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leg ergometer | Device | Leg cycling in bed using motorized ergometer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ambulation | Independent walking (with or without device) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological recovery | International Standards for Neurological Classification of Spinal Cord Injury | 6 months |
| Function | Spinal Cord Independence Measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Marc Mac-Thiong, MD, PhD | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | H4J1C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41947246 | Derived | 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. | |
| 34725077 |
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In line with the recommendations from the Committee on strategies for Responsible Sharing of Clinical Trial Data
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| UNKNOWN |
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| 6 months |
| Spasticity | Spinal Cord Assessment Tool for Spastic Reflexes | 6 months |
| Health related quality of life | Short-form 36 and World Health Organization Quality of Life - BREF | 6 months |
| 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. |
| D014947 | Wounds and Injuries |