Early Rehabilitation in Critically Ill Children Pilot Study
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 1

Summary: 
      Critically ill patients are often confined to bedrest, because of the nature of their
      illness. However, it has now been shown that prolonged bedrest and immobility, particularly
      in critically ill adults and children, can lead to serious outcomes such as muscle weakness
      and prolonged stay in the intensive care unit (ICU). Research in adults has demonstrated that
      preventing immobility and introducing exercise and rehabilitation in adult patients early
      during their ICU illness can prevent these serious outcomes, reduce the duration of hospital
      stay, and enhance their recovery after they leave the ICU. The purpose of our research is to
      investigate if early mobilization and rehabilitation can also be performed in critically ill
      children, and eventually evaluate this results in beneficial outcomes in these children, as
      it has been shown to be in adults. However, given that children are not the same as adults,
      but have varying abilities to understand and participate in activities when they are sick,
      the investigators first have to evaluate the most appropriate and safe ways of helping
      children "exercise" while they are in the ICU. This objective of this study is to evaluate if
      2 methods of rehabilitation (a stationary bike and interactive video game) can be implemented
      in critically ill children. These methods have been used in hospitalized children and in
      critically ill adults. The investigators will evaluate if these methods are safe for
      critically ill children.
    

Detailed description: 
      In this prospective cohort pilot study, eligible critically ill children aged 3 to 17 years
      will receive in addition to their usual care, a passive and/or an active mobility
      intervention, depending on their level of consciousness or cognitive ability. The active
      intervention will consist of an interactive video game (X Box 360 Kinect), while a cycle
      ergometer will be used as the passive intervention. The mobility interventions will be
      applied for a minimum of 10 minutes on day 1, and 20 minutes on day 2. For unconscious
      patients, or eligible patients who cognitively impaired, the passive intervention will be
      applied. As soon as the patient is conscious and cooperative, the active intervention will be
      applied.

      The primary outcomes of interest in this pilot study are feasibility (defined as the ability
      to screen and enroll patients, consent rate and protocol adherence). Secondary outcomes of
      interest include safety outcomes, clinical outcomes and patient and caregiver satisfaction
      with the intervention.
    

Intervention name(s): Early Rehabilitation intervention
Intervention type(s): Device
Intervention description(s): Passive mobility: cycle ergometer
Active mobility: interactive video-game (X Box 360 Kinect) Each intervention will be applied for a maximum of 2 days respectively. If a participant is unconscious on Day 1 and receives the passive intervention, and thereafter becomes alert and cooperative on day 2, then he/she can receive the active intervention.
Other intervention name(s): Cycle Ergometer; X Box 360 Kinect
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatrics,; Critically ill Children; immobility