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EarlySitingIschemicStroke
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Data from: Early Sitting in Ischemic Stroke Patients (SEVEL): A Randomized Controlled Trial

Creators

  • Fanny E. Herisson
  • Sophie Godard
  • Christelle Volteau
  • Emilie Le Blanc
  • Benoit Guillon
  • Marie Gaudron

Description

Background

Extended immobility has been linked to medical complications during hospitalization. Despite this, no definitive recommendations exist for the mobilization of ischemic stroke patients. Early mobilization has previously been shown to be feasible and safe. This study aimed to investigate whether early sitting could improve stroke patient outcomes.

Objective

To evaluate the effects of early sitting versus progressive sitting in acute ischemic stroke patients on functional outcomes and medical complications.

Methods

  • Study Design: Prospective multicenter randomized controlled trial
  • Registration: ClinicalTrials.gov NCT01573299
  • Eligibility: Patients over 18 years old with no signs of massive infarction or contraindication for sitting.
  • Interventions:
  • Early-Sitting Group: Patients were seated out of bed within one calendar day after stroke onset.
  • Progressively-Sitting Group: Patients were first seated out of bed on the third calendar day post-stroke.

Outcome Measures

  • Primary Outcome: Proportion of patients with modified Rankin Score [0–2] at 3 months post-stroke.
  • Secondary Outcomes:
  • Prevalence of medical complications
  • Length of hospital stay
  • Tolerance to the sitting procedure

Results

  • Participants: 167 patients enrolled; 29 excluded post-randomization.
  • Final sample: 138 patients (63 in early-sitting, 75 in progressive-sitting).
  • Primary Outcome:
  • Modified Rankin Score [0–2] at 3 months:
    • Early-sitting: 76.2%
    • Progressive-sitting: 77.3%
    • p = 0.52
  • Secondary Outcomes:
  • No significant differences observed between groups.
  • Both procedures were well tolerated.

Conclusion

  • Due to slow enrollment, the study was underpowered to detect small to moderate effects:
  • Power to detect ±15% effect: 37%
  • Power to detect effects >25%: 80%
  • No blinded assessment of the primary outcome was possible.
  • Nonetheless, findings suggest early sitting is safe and unlikely to have a large impact (positive or negative) on outcomes.
  • The study provides important insights for the development of acute stroke rehabilitation protocols and future trial designs involving early mobilization.

Notes

These results may support the clinical feasibility of early sitting post-stroke, but larger trials are necessary to confirm any modest effects on recovery.