Using Continuous Passive Motion to Prevent Ankle Problems in ICU Patients

Application of Continuous Passive Motion to Prevent Ankle Contracture and Muscle Loss in the Mechanically Ventilated Patients

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

Study Overview

• Status: Completed
• Conditions: Critical Illness; Muscle Atrophy; Mechanical Ventilation; ICU-acquired Weakness; Joint Contracture
• Intervention / Treatment: Device: Continuous Passive Motion (CPM)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 116
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Passive Ankle Dorsiflexion Range of Motion (ROM)	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 (°).	Baseline and Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tibialis Anterior Muscle Thickness	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).	Baseline and Day 7
Tibialis Anterior Muscle Cross-section Area	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).	Baseline and Day 7
Tibialis Anterior Muscle Pennation Angle	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 (°).	Baseline and Day 7
Tibialis Anterior Muscle Echointensity	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).	Baseline and Day 7

Collaborators and Investigators

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): March 14, 2025

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: mechanical ventilation; rehabilitation; critical illness; continuous passive motion; ICU-acquired weakness; ankle joint contracture; ultrasound muscle assessment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Disease Attributes; Joint Diseases; Atrophy; Critical Illness; Muscular Atrophy; Contracture
• Other Study ID Numbers: SKH-IRB-20240808R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) will not be shared due to the small sample size and the risk of re-identification, especially in a critically ill ICU population. The study was not designed with data sharing infrastructure in place.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No