Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units
Recruiting now · Not applicable
Conditions studied: Intensive Care Unit Acquired Weakness
In brief
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.
Key facts
- Study ID
- NCT06700694
- Run by
- Hsiao-Yean Chiu
- People needed
- 138
- Starts
- 2025-03-04
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-03-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged ≥ 18 years
- Being mechanically ventilated ≥ 24 hours
- Richmond Agitation-Sedation Scale (RASS): 0 to -1
- No vision, hearing, or body movements restriction
- With clear consciousness and ability to communicate in Chinese
- Expected to stay in the ICU > 96 hours.
You may not qualify if…
- 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.
Where it is running
- Taipei Medical University Hospital — Taipei, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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