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

NCT06700694 | Recruiting DMC

• 1 other identifier: N202403085
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Acquired Weakness

Outcome Measures

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.

  On the day of enrollment and ICU discharge (or up to 28 days after enrollment).

Secondary Outcomes (14)

• Muscle power

  On the day of enrollment and ICU discharge (or up to 28 days after enrollment).

• Hand-grip strength

  On the day of enrollment and ICU discharge (or up to 28 days after enrollment).

• Delirium

  Through intervention completion, up to 28 days.

• Subjective sleep status

  Through intervention completion, up to 28 days.

• Objective sleep status

  Through intervention completion, up to 28 days.

Study Arms (3)

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.

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.

Other: Protocol-oriented early mobilization program

Usual care group

NO INTERVENTION

Participants in the usual care group will receive routine rehabilitation treatment.

Interventions

Technology-assisted, family-engaged in-bed activities OTHER

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.

Technology-assisted early mobilization group

Protocol-oriented early mobilization program OTHER

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.

Systematic early mobilization group; Technology-assisted early mobilization group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Science and Technology Council, Taiwan: collaborator
• Hsiao-Yean Chiu: lead
• Taipei Medical University Hospital: collaborator

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Central Study Contacts

Hsiao-Yean Chiu, Ph.D.

CONTACT

+886-2-27361661#6329; hychiu0315@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 22, 2024
• Study Start: March 4, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

TW (1)