[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654237":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":53,"studyPopulation":45,"armGroups":54,"interventions":61,"overallOfficials":67,"centralContacts":71,"locations":79,"responsibleParty":100,"collaborators":45,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":45,"enrollmentInfo":112,"targetDuration":45,"studyType":115,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":126,"whyStopped":45,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"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","1 year",[14,18,21,24,27,30,33,36,39,42],{"measure":15,"description":16,"timeFrame":17},"Complications","Acute complications including pneumonia, urinary tract infection, pressure injury, spasticity, etc.","perioperatively\u002Fperiprocedurally",{"measure":19,"description":20,"timeFrame":12},"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",{"measure":22,"description":23,"timeFrame":12},"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",{"measure":25,"description":26,"timeFrame":12},"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",{"measure":28,"description":29,"timeFrame":12},"Presence or absence of neuropathic pain","International Spinal Cord Injury Pain Basic Data Set",{"measure":31,"description":32,"timeFrame":12},"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",{"measure":34,"description":35,"timeFrame":12},"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",{"measure":37,"description":38,"timeFrame":12},"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",{"measure":40,"description":41,"timeFrame":12},"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",{"measure":43,"description":44,"timeFrame":12},"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",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"NA","SINGLE_GROUP","Prospective longitudinal cohort study","TREATMENT",{"masking":52,"maskingDescription":45,"whoMasked":45},"NONE","GOALS: This longitudinal cohort study will investigate the clinical benefits of early acute exercise therapy after mild spinal cord injury (SCI).\n\nPrimary 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.\n\nSecondary hypothesis: Acute complications, neurological recovery, functional independence, quality of life and care pathway are improved with early acute exercise therapy.\n\nMETHODS: 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.",[55],{"label":56,"type":57,"description":58,"interventionNames":59},"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\u002For 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\u002Fadjusted by the research assistant until the target is reached.",[60],"Device: Cycling",[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":45},"DEVICE","Cycling","Seated cycling using motorized under desk exerciser",[56],[68],{"name":69,"affiliation":5,"role":70},"Jean-Marc Mac-Thiong, MD, PhD","PRINCIPAL_INVESTIGATOR",[72,76],{"name":69,"role":73,"phone":74,"phoneExt":45,"email":75},"CONTACT","1+514-338-2222","jean-marc.mac-thiong@umontreal.ca",{"name":77,"role":73,"phone":74,"phoneExt":45,"email":78},"Andreane Richard-Denis Richard-Denis, MD, MSc","andreane.rdenis@umontreal.ca",[80],{"facility":81,"status":45,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Hopital du Sacre-Coeur de Montreal","Montreal","Quebec","h4j1c5","Canada","CA",{"type":88,"coordinates":89},"Point",[90,91],-73.58781,45.50884,{"lat":91,"lon":90},[94,97,98],{"name":95,"role":73,"phone":74,"phoneExt":45,"email":96},"Lara Chawa","lara.chawa.cnmtl@ssss.gouv.qc.ca",{"name":69,"role":70,"phone":45,"phoneExt":45,"email":45},{"name":99,"role":70,"phone":45,"phoneExt":45,"email":45},"Andreane Richard-Denis, MD, MSc",{"type":70,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Jean-Marc Mac-Thiong","Professor","100654237","protocol-for-rapid-onset-of-mobilization-in-patients-with-traumatic-spinal-cord-injury-iii-prompt-sci-iii-trial-100654237",false,"NCT07798310","Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury III (PROMPT-SCI III) Trial","PROMPT-SCI III","Inclusion Criteria:\n\n* adults 18 years or older with non-penetrating traumatic SCI\n* SCI severity AIS grade D (motor function preserved with most key muscles able to move against gravity)\n* NLI between C0 and L2; and spine surgery performed within 48 hours of SCI\n\nExclusion Criteria:\n\n* intubated and mechanically ventilated\n* conditions interfering with patient safety or ability to undergo cycling\n* body mass index 40 kg\u002Fm2 or less (to prevent \"frog leg\" position during cycling)\n* moderate or severe traumatic brain injury\n* hemodynamic instability\n* pelvic or lower extremity\n* injury with weight-bearing or mobilization restrictions","ALL","18 Years",{"count":113,"type":114},107,"ESTIMATED","INTERVENTIONAL",[47],"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.",[119],"Spinal Cord Injuries, Incomplete",[121,122,123,124,125],"spinal cord injury","activity-based therapy","exercise therapy","rehabilitation","acute care","NOT_YET_RECRUITING","2026-08-31",{"date":129,"type":130},"2026-09-02","ACTUAL",{"date":132,"type":114},"2026-09-01",{"date":134,"type":114},"2031-01-31",{"name":5,"class":6},1]