Using Continuous Passive Motion to Prevent Ankle Problems in ICU Patients

Not Applicable

Completed

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

• Registration Number: NCT06944431
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-20
• Primary Completion: 2025-02-24
• Study Completion: 2025-03-14
• Status Verified: 2025-04
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-25
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Passive Ankle Dorsiflexion Range of Motion (ROM)	Baseline and Day 7	Difference in passive ankle dorsiflexion angle between baseline and Day 7, measured using a goniometer. The left (intervention) and right (control) ankles will be compared within each subject. Reported in degrees (°).

Secondary Outcome Measures

Name	Time	Method
Tibialis Anterior Muscle Thickness	Baseline and Day 7	Change in muscle thickness of the tibialis anterior as measured by ultrasound. Measurements will be obtained directly from B-mode ultrasound images using the built-in caliper function of the ultrasound machine. Values will be reported in centimeters (cm).
Tibialis Anterior Muscle Cross-section Area	Baseline and Day 7	Change in cross-sectional area of the tibialis anterior muscle as measured by ultrasound. Measurements will be obtained directly using the built-in area tracing tool on the ultrasound machine during B-mode imaging. Values will be reported in square centimeters (cm²).
Tibialis Anterior Muscle Pennation Angle	Baseline and Day 7	Change in pennation angle of the tibialis anterior muscle as measured from B-mode ultrasound images. Angle will be calculated using ImageJ software from the fascicle orientation relative to the deep aponeurosis. Reported in degrees (°).
Tibialis Anterior Muscle Echointensity	Baseline and Day 7	Change in echointensity of the tibialis anterior muscle as measured from B-mode ultrasound images. Echointensity will be quantified using ImageJ software as the mean and standard deviation of grayscale values within a manually selected region of interest (ROI), ranging from 0 (black) to 255 (white). Reported in grayscale arbitrary units (AU).

Trial Locations

Locations (1)

Shin Kong Wu Ho-su Memorial Hospital; 🇨🇳 Taipei City, Taiwan