Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHsiao-Yean Chiu
About this trial
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
This trial does not accept healthy volunteersQualifiers
Aged ≥ 18 years
Being mechanically ventilated ≥ 24 hours
Richmond Agitation-Sedation Scale (RASS): 0 to -1
No vision, hearing, or body movements restriction
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Technology-assisted, family-engaged in-bed activities
Other interventionTechnology-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.
Protocol-oriented early mobilization program
Other interventionThe 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.
Treatment groups
138 Participants
are divided into 3 treatment groupsGroup A: Technology-assisted early mobilization groupExperimental treatment 2 interventions
Group B: Systematic early mobilization groupActive comparator 1 intervention
Group C: Usual care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Occurrence of intensive care unit-acquired weakness (ICUAW)
The occurrence of ICUAW will primarily be assessed using the Medical Research Council (MRC) scale. An MRC sum score of less than 48 indicates the presence of ICUAW.
Time frame
On the day of enrollment and ICU discharge (or up to 28 days after enrollment).Secondary outcomes
1
Muscle power
Muscle power will be evaluated using the MRC scale, which assesses the strength of six bilateral muscle groups rated from 0 (complete paralysis) to 5 (normal strength) for each group. The total score ranges from 0 to 60.
Time frame
On the day of enrollment and ICU discharge (or up to 28 days after enrollment).2
Hand-grip strength
Hand-grip strength will be measured using a hydraulic hand dynamometer. A strength of less than 11 kg for males and less than 7 kg for females indicates the presence of ICUAW. This outcome will be used to assess the occurrence of ICUAW, as determined by the MRC sum score, concurrently.
Time frame
On the day of enrollment and ICU discharge (or up to 28 days after enrollment).3
Delirium
Delirium is assessed by the Intensive Care Delirium Screening Checklist (ICDSC), which includes eight items. Each item is scored as absent (0) or present (1), with total score ranging from 0 to 8. A score of ≥ 4 indicates the presence of delirium. The scoring is based on observations during every nursing shift.
Time frame
Through intervention completion, up to 28 days.4
Subjective sleep status
Richards-Campbell Sleep Questionnaire (RCSQ) will be used to assess subjective sleep quality on a visual analog scale among patients in the ICU. The total score is calculated with a formula and categorized into four levels: \< 26 is very poor, 26-50 is poor, 51-75 is good, and \> 76 is excellent.
Time frame
Through intervention completion, up to 28 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hsiao-Yean Chiu
Lead sponsor
Taipei Medical University
Sponsor institution
Taipei Medical University Hospital
Collaborator
National Science and Technology Council, Taiwan
Collaborator
Source ClinicalTrials.gov