Using Continuous Passive Motion to Prevent Ankle Problems in ICU Patients

Shin Kong Wu Ho-Su Memorial Hospital

Status: Completed

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

Treatments: Device: Continuous Passive Motion (CPM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06944431

SKH-IRB-20240808R

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

CPM Intervention Group

Experimental group

Description:

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.

Treatment:

Device: Continuous Passive Motion (CPM)