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

NCT ID: NCT06700694

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2027-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Technology-assisted early mobilization group

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.

Group Type: EXPERIMENTAL

Technology-assisted, family-engaged in-bed activities

Intervention Type: 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.

Protocol-oriented early mobilization program

Intervention Type: 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

Participants allocated to the systematic early mobilization group will receive the same protocol-oriented early mobilization program within 72 hours of ventilator use.

Group Type: ACTIVE_COMPARATOR

Protocol-oriented early mobilization program

Intervention Type: 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.

Usual care group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Hospital

OTHER

Sponsor Role: collaborator

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Hsiao-Yean Chiu

OTHER

Sponsor Role: lead

Responsible Party

Hsiao-Yean Chiu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Hsiao-Yean Chiu, Ph.D.

Role: CONTACT

hychiu0315@tmu.edu.tw

+886-2-27361661#6329

Other Identifiers

N202403085

Identifier Type: -

Identifier Source: org_study_id