NCT06700694 Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units
| NCT ID | NCT06700694 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hsiao-Yean Chiu |
| Condition | Intensive Care Unit Acquired Weakness |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2025-03-04 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 138 participants in total. It began in 2025-03-04 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06700694 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intensive Care Unit Acquired Weakness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06700694 currently recruiting?
Yes, NCT06700694 is actively recruiting participants. Contact the research team at hychiu0315@tmu.edu.tw for enrollment information.
Where is the NCT06700694 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06700694 clinical trial?
NCT06700694 is sponsored by Hsiao-Yean Chiu. The trial plans to enroll 138 participants.