Early Rehabilitation in Critically Ill Children Pilot Study (WeeHab in PCCU)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Early Rehabilitation in Critically Ill Children, a Pilot Study|
- Feasibility [ Time Frame: 2 days ] [ Designated as safety issue: No ]
The primary outcome of interest in this pilot study is feasibility. Feasibility is defined as follows:
- The ability to screen and enroll eligible patients - enrolment rate of at least 70% of those approached for consent (benchmark for PCCU trials)
- Time to application of acute rehabilitation intervention.
- Protocol adherence - a protocol violation rate of < 10%.
- Safety [ Time Frame: Study period ] [ Designated as safety issue: Yes ]The proportion of patients with adverse events attributable to the rehabilitation intervention (e.g. cardiorespiratory events, tube dislodgement's).
- Change in activity from baseline [ Time Frame: From baseline to end of intervention ] [ Designated as safety issue: No ]Change in activity from baseline, during and following the intervention as measured by accelerometer, and patient
- Caregiver/user perception of intervention [ Time Frame: At end of study period ] [ Designated as safety issue: No ]Self-administered survey of caregiver and or user, to evaluate perceptions of intervention
|Study Start Date:||February 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Single Arm: Study Intervention
Cycle ergometry and/or Interactive video-game
Device: Early Rehabilitation intervention
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531816
|McMaster Children's Hospital|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Karen Choong, MB, BCh, MSc||McMaster University|