Using Continuous Passive Motion to Prevent Ankle Problems in ICU Patients

NCT ID: NCT06944431

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-20
• Study Completion Date: 2025-03-14

Brief Summary

The goal of this clinical trial is to learn if continuous passive motion (CPM) helps prevent ankle joint contracture and muscle loss in critically ill, mechanically ventilated ICU patients. It will also evaluate the feasibility and safety of implementing CPM in this population. The main questions it aims to answer are:

Does CPM help preserve ankle dorsiflexion range of motion during immobilization in the ICU?

Can ultrasound measurements detect changes in tibialis anterior muscle condition in response to CPM?

Researchers will compare one ankle receiving CPM to the other ankle without intervention in the same patient to assess differences in joint mobility and muscle morphology.

Participants will:

Receive CPM therapy on one ankle for 30 minutes, twice daily, over a 7-day period or until ICU discharge

Undergo goniometric and ultrasound assessments at baseline and at the end of the intervention

Remain under usual ICU care and monitoring while enrolled in the study

Conditions

Joint Contracture; Mechanical Ventilation; ICU-acquired Weakness; Critical Illness; Muscle Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CPM Intervention Group

All participants received continuous passive motion (CPM) therapy on the left ankle once daily for 7 consecutive days during mechanical ventilation. The right ankle served as the within-subject control with no intervention. This single-arm study used a within-subject control design.

Group Type: EXPERIMENTAL

Continuous Passive Motion (CPM)

Intervention Type: DEVICE

Continuous passive motion was applied to the left ankle joint for 60 minutes per day using a motorized CPM device. The therapy was initiated within 48 ho

Interventions

Continuous Passive Motion (CPM)

Continuous passive motion was applied to the left ankle joint for 60 minutes per day using a motorized CPM device. The therapy was initiated within 48 ho

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults aged ≥ 18 years
• Admitted to the ICU with acute respiratory failure requiring mechanical ventilation
• Expected to remain mechanically ventilated for at least 7 days
• Sedated and unable to participate in active mobilization
• No contraindications for passive ankle movement
• Informed consent obtained from legal representative

Exclusion Criteria

• Pre-existing neuromuscular disorders affecting lower limb mobility (e.g., stroke with hemiparesis, myasthenia gravis)
• Recent orthopedic surgery or trauma involving the lower limbs
• Presence of lower limb amputation
• Peripheral vascular disease with critical limb ischemia
• Active deep vein thrombosis in either leg
• Significant wounds, pressure ulcers, or skin breakdown at the heel
• Pregnancy

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

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shin Kong Wu Ho-su Memorial Hospital

Taipei, Taiwan, Taiwan

Countries

Taiwan

References

Lin CC, Lin YJ, Wang HC, Hsu WC. Continuous passive motion for prevention of ankle contracture and muscle loss in mechanically ventilated ICU patients. BMC Res Notes. 2025 Oct 1;18(1):409. doi: 10.1186/s13104-025-07457-z.

Reference Type: DERIVED

PMID: 41035043 (View on PubMed)

Other Identifiers

SKH-IRB-20240808R

Identifier Type: -

Identifier Source: org_study_id