RecruitingNot ApplicableNCT06700694

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

The Effect of Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units: A Randomized Controlled Trial

Sponsor

Hsiao-Yean Chiu

Enrollment

138 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

Intensive care Unit acquired weakness

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria3

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.

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Interventions

OTHERTechnology-assisted, family-engaged in-bed activities

Technology-assisted, family-engaged in-bed activities include handgrip interactive games, virtual reality butterfly catching, virtual reality magic cube games, and immersive in-bed cycling, performed 20 minutes per session, twice daily, five days a week, primarily assisted by family members.

OTHERProtocol-oriented early mobilization program

The protocol-oriented early mobilization program is implemented based on the patient's muscle strength and the Intensive care unit Mobility Scale (IMS), including lying, sitting, standing, stepping, and walking, once daily for 20-60 minutes, five days a week, carried out by physiotherapist and researcher.