Intensive Care Unit Acquired WeaknessNCT06700694
Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units
A study testing Technology-assisted, family-engaged in-bed activities and Protocol-oriented early mobilization program in people with Intensive Care Unit Acquired Weakness, run by Hsiao-Yean Chiu at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Acquired Weakness
- What is being tested?
- Technology-assisted, family-engaged in-bed activities and Protocol-oriented early mobilization program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Hsiao-Yean Chiu, +886-2-27361661#6329, hychiu0315@tmu.edu.tw
About this study
Official title: The Effect of Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units: A Randomized Controlled 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.
- Conditions
- Intensive Care Unit Acquired Weakness
- Being tested
- Technology-assisted, family-engaged in-bed activities, Protocol-oriented early mobilization program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-assisted, family-engaged in-bed activitiesOther
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.
Protocol-oriented early mobilization programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Technology-assisted early mobilization group | Experimental | 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. Receives: Other: Technology-assisted, family-engaged in-bed activities; Other: Protocol-oriented early mobilization program |
| Systematic early mobilization group | Active comparator | Participants allocated to the systematic early mobilization group will receive the same protocol-oriented early mobilization program within 72 hours of ventilator use. Receives: Other: Protocol-oriented early mobilization program |
| Usual care group | No intervention | Participants in the usual care group will receive routine rehabilitation treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).
Secondary outcomes (14)
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.
Measured: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).
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.
Measured: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).
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.
Measured: Through intervention completion, up to 28 days.
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.
Measured: Through intervention completion, up to 28 days.
Objective sleep status
Objective sleep status will be evaluated by SOMNOwatch™, which can extract not only sleep related parameters but also calculate sleep stages using additional electroencephalography (EEG) sensors.
Measured: Through intervention completion, up to 28 days.
Functional Status
Functional Status Score for the Intensive Care Unit (FSS-ICU) is used to assess the functional status of patients in the ICU. Patient's performance of five functional movements will be rated from 0 to 7. The total score ranges from 0 to 35, with higher scores indicating better functional status.
Measured: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).
Duration of ventilation use
The duration of ventilation use is specified the accumulated days of using mechanical ventilation with endotracheal tube in the ICU for this hospitalization. This outcome will be recorded from the hospital's electronic system.
Measured: On the day of hospital discharge (expected up to 3 month).
Length of stay in the ICU
The length of stay in the ICU will be recorded from the hospital's electronic system.
Measured: On the day of hospital discharge (expected up to 3 month).
Length of stay in the hospital
The total length of stay in the hospital will be recorded from the hospital's electronic system.
Measured: On the day of hospital discharge (expected up to 3 month).
Adverse event
Any adverse events occur during the intervention session.
Measured: Through intervention completion, up to 28 days.
Activities of daily living (ADL)
The ADL will be assessed by the Barthel Index. The total score ranges from 0 to 100. A score of ≥ 70 indicates independent daily living abilities.
Measured: 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
The Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality over the past month. Score ranges from 0 to 21, with a score > 5 indicating poor sleep quality; higher scores reflect worse sleep quality.
Measured: On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge.
Quality of life (QoL)
The EuroQol Five-Dimensional Five-Level Scale (EQ-5D-5L) is used to evaluate health-related QoL. The health status classification comprises five dimensions, each with five levels, calculated using specific values. The vertical analog scale assesses the patient's overall evaluation of their current health status, ranging from 0 to 100. Higher scores indicate greater QoL.
Measured: On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge.
psychological distress
Depression, anxiety, and stress-21 items (DASS-21) will be used to assess patients' level of psychological distress. It contains 21 items, using the likert scale, where 0 indicates no effect, 1 indicates occasional effect, 2 indicates very effective, and 3 indicates extremely effective. There are seven items each for depression, anxiety, and stress. The total score for each item is calculated by adding them together and multiplying by two, ranging from 0 to 42. Higher scores indicate a more severe mood disorder. This scale has been proven to have good reliability and efficacy in medical institutions, community environments, various cultural groups, and healthy individuals, and is also commonly used for critically ill patients.
Measured: On the day of enrollment, ICU discharge (or up to 28 days after enrollment), on the day of hospital discharge (expected up to 3 month), and six-month after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start4 Mar 2025
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit Acquired WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hsiao-Yean Chiu
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Hospital, National Science and Technology Council, Taiwan
- Responsible party
- Sponsor-investigator, Hsiao-Yean Chiu, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700694
- Sponsor's protocol ID
- N202403085
- Status last verified
- Mar 2026
- First submitted
- 1 Nov 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06700694
- Acronym / sponsor ID
- N202403085
- Conditions
- Intensive Care Unit Acquired Weakness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Hsiao-Yean ChiuUniversity, hospital or other
- Collaborators
- Taipei Medical University Hospital, National Science and Technology Council, Taiwan
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Technology-assisted early mobilization group | Experimental | Other: Technology-assisted, family-engaged in-bed activities, Other: Protocol-oriented early mobilization programParticipants 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. |
| Systematic early mobilization group | Active comparator | Other: Protocol-oriented early mobilization programParticipants allocated to the systematic early mobilization group will receive the same protocol-oriented early mobilization program within 72 hours of ventilator use. |
| Usual care group | No intervention | –Participants in the usual care group will receive routine rehabilitation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-assisted, family-engaged in-bed activitiesTechnology-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 | Technology-assisted early mobilization group |
| Protocol-oriented early mobilization programThe 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. | Other | Systematic early mobilization group, Technology-assisted early mobilization group |
Primary outcome
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).
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.
14 secondary outcomes
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.
Quality of life (QoL)
Time frame: On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge.
psychological distress
Time frame: On the day of enrollment, ICU discharge (or up to 28 days after enrollment), on the day of hospital discharge (expected up to 3 month), and six-month after hospital discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-assisted, family-engaged in-bed activities and Protocol-oriented early mobilization program in people with Intensive Care Unit Acquired Weakness, run by Hsiao-Yean Chiu at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiao-Yean Chiu, Ph.D. (+886-2-27361661#6329, hychiu0315@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.