Actively Recruiting
The Effect of Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units: A Randomized Controlled Trial
Led by Hsiao-Yean Chiu · Updated on 2026-03-09
138
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
H
Hsiao-Yean Chiu
Lead Sponsor
T
Taipei Medical University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a technology-assisted early mobilization program among patients in intensive care units who are critically ill and using ventilators. This randomized controlled trial includes 138 patients assigned to one of three groups: a technology-assisted early mobilization group, a systematic early mobilization group, or a usual care group. The study aims to compare these approaches in preventing intensive care unit-acquired weakness (ICUAW) and improving muscle strength, delirium, sleep status, clinical outcomes, daily activities, and quality of life. Participants in the technology-assisted early mobilization group receive a protocol-based early mobilization program delivered by physiotherapists and researchers, plus family-assisted technology-based in-bed activities such as handgrip interactive games, virtual reality games, and immersive in-bed cycling. These activities are performed twice daily for 20 minutes each session, five days a week, starting within 72 hours of ventilator use. The systematic early mobilization group receives the same protocol-based program without the technology-assisted activities. The usual care group receives routine rehabilitation treatment. Interventions are applied during the ICU stay. Participants are assessed on enrollment day, during their ICU stay, on ICU discharge day (or up to 28 days), at hospital discharge, and six months post-discharge. Measurements include muscle power, hand-grip strength, delirium, sleep quality (subjective and objective), functional status, duration of ventilation, lengths of ICU and hospital stay, adverse events, activities of daily living, quality of life, and psychological distress. Safety and clinical outcomes are monitored throughout the study, which lasts several months including follow-up.
CONDITIONS
Brief Title
Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 218 years
- Being mechanically ventilated 224 hours
- Richmond Agitation-Sedation Scale (RASS) score between 0 and -1
- No restrictions in vision, hearing, or body movements
- Clear consciousness and ability to communicate in Chinese
- Expected to stay in the ICU for more than 96 hours
You will not qualify if you...
- Developed delirium before enrollment (ICDSC > 4)
- Acute physiology and chronic health evaluation (APACHE II) score greater than 25 within 24 hours after ICU admission
- Muscle weakness caused by severe acute brain injury, spinal cord injury, other neuromuscular conduction diseases, long-term bedridden status, or hemiplegia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days or until ICU discharge
Participants receive early mobilization interventions including protocol-oriented mobilization once daily and, if assigned, technology-assisted, family-engaged in-bed activities twice daily, five days a week.
Daily visits for up to 28 days
Duration - Up to 6 months after hospital discharge
Participants are assessed for outcomes including activities of daily living, sleep quality, quality of life, and psychological distress after hospital discharge and up to six months.
Visits at hospital discharge and at six months post-discharge
Trial Site Locations
Total: 1 location
1
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
Research Team
H
Hsiao-Yean Chiu, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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