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Early Rehabilitation in Critically Ill Children Pilot Study (WeeHab in PCCU)

This study is currently recruiting participants.
Verified October 2012 by McMaster University
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01531816
First received: February 7, 2012
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Critical Illness
 Device: Early Rehabilitation intervention
 Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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:

    1. The ability to screen and enroll eligible patients - enrolment rate of at least 70% of those approached for consent (benchmark for PCCU trials)
    2. Time to application of acute rehabilitation intervention.
    3. Protocol adherence - a protocol violation rate of < 10%.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm: Study Intervention
Cycle ergometry and/or Interactive video-game
 Device: Early Rehabilitation intervention
  1. Passive mobility: cycle ergometer
  2. 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 Names:
  • Cycle Ergometer
  • X Box 360 Kinect

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.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Anticipated PCCU stay of more than 24 hours.
  2. Clinical stable children at PCCU
  3. Informed consent and or assent where appropriate
  4. Agreement of the most responsible PCCU physician
  5. Age ≥ 3years to < 18 years

Exclusion Criteria:

  1. Hemodynamic instability, defined as requiring escalation in vasoactive agents or volume resuscitation within the preceding 4 hours. (Patients who are on stable or weaning doses of vasoactive agents will be considered eligible).
  2. Anticipated death and/ or withholding of life-sustaining therapies
  3. The presence of a contraindication to mobilization- e.g. Suspected or actual evidence of cerebral edema or elevated ICP, unstable spinal cord injuries, musculoskeletal injuries/ fixed deformities in the lower limbs (for the use of cycle ergometer) or the upper limbs (for the use of interactive video-gaming)
  4. Unstable airway (defined as impending respiratory failure and/or endotracheal intubation is anticipated within the next 4 hours).
  5. Patients who are already mobilizing well/or at their baseline level of function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531816

Locations
Canada, Ontario
McMaster Children's Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Karen Choong, MB, BCh, MSc     905-5212100 ext 75617     choongk@mcmaster.ca    
Sub-Investigator: Brian Timmons, PhD            
Principal Investigator: Ghadah Al-Mahr, MD            
Principal Investigator: Maria Chacon, MD            
Sub-Investigator: Heather Clark, BSc            
Sub-Investigator: Lehana Thabane, PhD            
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Karen Choong, MB, BCh, MSc     905-5212100 ext 75617     choongk@mcmaster.ca    
Contact: Karen Burns     905-5212100 ext 76651     burnsk@mcmaster.ca    
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Karen Choong, MB, BCh, MSc McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01531816     History of Changes
Other Study ID Numbers: 12-008
Study First Received: February 7, 2012
Last Updated: October 31, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Pediatrics,
Critically ill Children
immobility

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013