Technology-assisted early mobilization for ICU patients on ventilators
The Effect of Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units: A Randomized Controlled Trial
NA · Taipei Medical University · NCT06700694
This trial will test whether a technology-assisted, family-engaged early mobilization program helps critically ill adults on ventilators avoid ICU-acquired weakness.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Taipei Medical University (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06700694 on ClinicalTrials.gov |
What this trial studies
This single-blind, three-arm randomized trial will enroll 138 critically ill adults and randomize them 1:1:1 to a technology-assisted early mobilization group, a systematic protocol-oriented early mobilization group, or usual care. Interventions start within 72 hours of ventilator use and the technology-assisted arm adds in-bed activities supported primarily by family members alongside physiotherapist-led protocolized mobilization. The systematic early mobilization arm receives the same protocolized mobilization without the technology/family component, while the control arm receives routine rehabilitation. The primary outcome is occurrence of ICU-acquired weakness, with secondary outcomes including muscle strength, delirium, sleep status, and other clinical outcomes.
Who should consider this trial
Good fit: Adults aged 18 or older who have been mechanically ventilated at least 24 hours, have RASS between 0 and -1, can communicate in Chinese, have no major sensory or movement restrictions, and are expected to remain in the ICU more than 96 hours are ideal candidates.
Not a fit: Patients with preexisting severe brain or spinal injury, neuromuscular disease, delirium at enrollment, very high early APACHE II scores (>25), or those unable to follow commands or with anticipated short ICU stays are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could reduce ICU-acquired weakness and improve muscle strength and recovery after critical illness.
How similar studies have performed: Prior studies of early mobilization in the ICU have shown benefits for reducing weakness and improving outcomes, but technology-assisted, family-delivered in-bed programs remain relatively novel with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Taipei
- Taipei Medical University Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Hsiao-Yean Chiu, Ph.D.
- Email: hychiu0315@tmu.edu.tw
- Phone: +886-2-27361661#6329
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intensive Care Unit Acquired Weakness