Early Rehabilitation in Critically Ill Children Pilot Study

NCT01531816 | Completed Phase 1

• 1 other identifier: 12-008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness

Keywords

Pediatrics,; Critically ill Children; immobility

Outcome Measures

Primary Outcomes (1)

• Feasibility

  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%.

  2 days

Secondary Outcomes (3)

• Safety

  Study period

• Change in activity from baseline

  From baseline to end of intervention

• Caregiver/user perception of intervention

  At end of study period

Study Arms (1)

Single Arm: Study Intervention

EXPERIMENTAL

Cycle ergometry and/or Interactive video-game

Device: Early Rehabilitation intervention

Interventions

Early Rehabilitation intervention DEVICE

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.

Also known as: Cycle Ergometer, X Box 360 Kinect

Single Arm: Study Intervention

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).
• Anticipated death and/ or withholding of life-sustaining therapies
• 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)
• Unstable airway (defined as impending respiratory failure and/or endotracheal intubation is anticipated within the next 4 hours).
• Patients who are already mobilizing well/or at their baseline level of function

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Choong, MB, BCh, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 13, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

CA (1)