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Completed

NCT Number: NCT06944431

Using Continuous Passive Motion to Prevent Ankle Problems in ICU 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

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Key information

Conditions

Joint Contracture Atrophy Critical Illness Disease Attributes ICU-acquired Weakness Mechanical Ventilation Muscle Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shin Kong Wu Ho-su Memorial Hospital

Taipei, Taiwan, 116

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Passive Motion (CPM)

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

Primary outcomes

  1. Change in Passive Ankle Dorsiflexion Range of Motion (ROM)

    Time frame: 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 outcomes

  1. Tibialis Anterior Muscle Thickness

    Time frame: 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).

  2. Tibialis Anterior Muscle Cross-section Area

    Time frame: 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).

  3. Tibialis Anterior Muscle Pennation Angle

    Time frame: 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 (°).

  4. Tibialis Anterior Muscle Echointensity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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