Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHsiao-Yean Chiu

About this trial

This single-blind, three-group parallel randomized controlled trial will involve 138 patients with critical illness, randomly assigned at a 1:1:1 ratio to the technology-assisted early mobilization group (46 patients), the systematic early mobilization group (46 patients), or the control group (46 patients). The technology-assisted early mobilization group will receive interventions within 72 hours of ventilator use. The interventions include protocol-oriented early mobilization program carried out by physiotherapist and researcher and technology-assisted in-bed activities primarily assisted by family members. The systematic early mobilization group will receive only the similar protocol-oriented early mobilization program within 72 hours of ventilator use. The control group will receive routine rehabilitation as usual. The primary outcomes include occurrence of intensive care unit-acquired weakness (ICUAW). Secondary outcomes include muscle strength, delirium, sleep status, clinical outcomes, activities of daily living, and quality of life. Measurements will be assessed on the day of enrollment, during the ICU stay, on the day of ICU discharge (or up to 28 days), on the day of hospital discharge, and six months after hospital discharge.

Eligibility criteria

Qualifiers

Aged ≥ 18 years

Being mechanically ventilated ≥ 24 hours

Richmond Agitation-Sedation Scale (RASS): 0 to -1

No vision, hearing, or body movements restriction

Disqualifiers

Have developed delirium before enrollment (ICDSC > 4)

With acute physiology and chronic health evaluation (APACHE II) score > 25 after ICU admission within 24 hours

With muscle weakness caused by severe acute brain injury (e.g., traumatic brain injury or stroke), spinal coral injury, other neuromuscular conduction diseases, or long-term bedridden or hemiplegia.

Trial design

Treatments tested in this trial

  • Technology-assisted, family-engaged in-bed activities
  • Protocol-oriented early mobilization program

Treatment groups

138 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Hsiao-Yean Chiu

Lead sponsor

Taipei Medical University

Sponsor institution

Taipei Medical University Hospital

Collaborator

National Science and Technology Council, Taiwan

Collaborator