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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Taipei Medical University Hospital
RECRUITING
Taipei
Contact Information
Primary
Hsiao-Yean Chiu, Ph.D.
hychiu0315@tmu.edu.tw
+886-2-27361661#6329
Time Frame
Start Date: 2025-03-04
Estimated Completion Date: 2027-04
Participants
Target number of participants: 138
Treatments
Experimental: Technology-assisted early mobilization group
Participants in the technology-assisted early mobilization group will receive protocol-oriented early mobilization program and technology-assisted, family-engaged in-bed activities within 72 hours of ventilator use.
Active_comparator: Systematic early mobilization group
Participants allocated to the systematic early mobilization group will receive the same protocol-oriented early mobilization program within 72 hours of ventilator use.
No_intervention: Usual care group
Participants in the usual care group will receive routine rehabilitation treatment.
Related Therapeutic Areas
Sponsors
Leads: Hsiao-Yean Chiu
Collaborators: Taipei Medical University Hospital, National Science and Technology Council, Taiwan

This content was sourced from clinicaltrials.gov