Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Technology-assisted, family-engaged in-bed activities, Protocol-oriented early mobilization program.
- Who it may be relevant to
- Registry conditions: Intensive Care Unit Acquired Weakness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units: A Randomized Controlled Trial
Overview
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.
Interventions
- Other Technology-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. - Other Protocol-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.
Primary outcome measures
- Occurrence of intensive care unit-acquired weakness (ICUAW) [Time frame: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).]
Secondary outcome measures (12)
- Muscle power [Time frame: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).]
- Hand-grip strength [Time frame: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).]
- Delirium [Time frame: Through intervention completion, up to 28 days.]
- Subjective sleep status [Time frame: Through intervention completion, up to 28 days.]
- Objective sleep status [Time frame: Through intervention completion, up to 28 days.]
- Functional Status [Time frame: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).]
- Duration of ventilation use [Time frame: On the day of hospital discharge (expected up to 3 month).]
- Length of stay in the ICU [Time frame: On the day of hospital discharge (expected up to 3 month).]
- Length of stay in the hospital [Time frame: On the day of hospital discharge (expected up to 3 month).]
- Adverse event [Time frame: Through intervention completion, up to 28 days.]
- Activities of daily living (ADL) [Time frame: On the day of ICU discharge (up to 28 days after enrollment), hospital discharge (expected up to 3 month), and six-month after hospital discharge.]
- Sleep quality [Time frame: On the day of hospital discharge (expected up to 3 month) and six-month 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Taiwan · 1 center
- Taipei Medical University Hospital — Taipei
Identifiers
NCT: NCT06700694 · N202403085