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NCT06700694 | NOT YET RECRUITING | Intensive Care Unit Acquired Weakness

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

Hsiao-Yean Chiu

Information provided by (Responsible Party):

Hsiao-Yean Chiu

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.

Condition or disease

Intensive Care Unit Acquired Weakness

Intervention/treatment

Technology-assisted, family-engaged in-bed activities

Protocol-oriented early mobilization program

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 138 participants
Masking : SINGLE
Primary Purpose : PREVENTION
Official Title : The Effect of Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units: a Randomized Controlled Trial
Actual Study Start Date : 2025-02
Estimated Primary Completion Date : 2027-02
Estimated Study Completion Date : 2027-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
  • * Being pregnant, menopausal, or having a night shift within one month before admission to the ICU
  • * 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.
Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units

Location Details

NCT06700694

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