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NCT Number: NCT07032051

Continuous Passive Motion to Prevent Ankle Contracture and Muscle Atrophy in Ventilated Patients

This clinical trial aims to evaluate whether continuous passive motion (CPM) can prevent ankle joint contracture and muscle atrophy in critically ill patients receiving mechanical ventilation in the ICU. The study will also assess the feasibility and safety of implementing CPM therapy in this population.

The primary objectives are:

To determine whether CPM preserves ankle dorsiflexion range of motion during ICU immobilization.

To assess whether ultrasound can detect changes in tibialis anterior muscle morphology in response to CPM.

In this within-subject design, each participant will receive CPM therapy on one ankle while the contralateral ankle serves as the control. Outcomes related to joint mobility and muscle condition will be compared between the two sides.

Participants will:

Receive CPM treatment on one ankle for 30 minutes, twice daily, for up to 7 days or until ICU discharge.

Undergo goniometric and ultrasound assessments at baseline and after the intervention.

Continue to receive standard ICU care throughout the study period.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Critically ill patients commonly experience neuromuscular complications, notably intensive care unit-acquired weakness (ICU-AW) and joint contractures. ICU-AW affects up to 80% of patients requiring prolonged mechanical ventilation and is associated with prolonged hospitalization, delayed functional recovery, and increased mortality. Concurrently, immobility during ICU stays contributes significantly to joint contractures, affecting approximately one-third of patients experiencing extended ICU admissions. Among these complications, ankle joint plantar-flexion contractures (foot drop) are particularly debilitating, severely impacting patients' balance, gait retraining, and overall functional recovery after ICU discharge.

Although early mobilization is widely recognized as beneficial, leading to reduced ICU stays, lower incidence of delirium, preservation of muscle integrity, and enhanced quality of life post-discharge, its implementation remains challenging. Many critically ill patients are unable to participate in early active mobilization due to sedation, hemodynamic instability, or other medical contraindications. Furthermore, evidence suggests that early mobilization might carry increased risks of adverse events for certain patient populations. Thus, alternative strategies are essential for patients unsuitable for early active rehabilitation, emphasizing preservation of joint mobility and muscle integrity to facilitate future rehabilitation opportunities.

Continuous passive motion (CPM) therapy has emerged as a viable intervention designed initially for postoperative orthopedic rehabilitation. CPM passively moves joints through a controlled range, potentially maintaining flexibility by inhibiting periarticular collagen cross-linking, preserving soft tissue extensibility, and maintaining muscle-tendon compliance. However, its effectiveness in critical illness settings remains uncertain, with limited evidence suggesting potential benefits in reducing muscle atrophy, such as that of the tibialis anterior muscle, in ICU patients unable to actively mobilize, while other studies have reported minimal effects. Thus, rigorous evaluation of CPM's impact on joint mobility preservation and muscle atrophy prevention is warranted.

This study aimed to evaluate whether CPM therapy effectively mitigates passive range of motion (PROM) loss at the ankle joint in sedated, mechanically ventilated ICU patients. Additionally, muscle structural changes were assessed via ultrasound imaging to determine if CPM influences muscle morphology compared to limbs receiving standard care alone. Ultrasound parameters, including muscle thickness (MT), cross-sectional area (CSA), echointensity (EI), and pennation angle (PA), were used to comprehensively monitor morphological changes and provide insights into the functional implications of observed alterations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eligible participants were adults (≥18 years) with acute respiratory failure expected to require mechanical ventilation for >5 days.

Exclusion criteria

  • Neuromuscular disorders
  • Recent lower limb surgery or trauma
  • Critical limb ischemia
  • Limb amputation
  • Deep vein thrombosis
  • Significant leg wounds
  • Pregnancy.

Treatment and study plan

Continuous Passive Motion

Device

Continuous passive motion was applied to the left ankle joint for 30 minutes twice a day using a motorized CPM device.

Primary outcomes

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

    Time frame: Baseline and Day 7 or until ICU discharge

    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 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).

Study contacts

Contact information is provided by the study sponsor or research team.

CHEN-CHUN LIN, MD

CONTACT

[email protected]

+886960032062

Sponsors and collaborators

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Other

Registry information

Official study title

Preventive Effects of Continuous Passive Motion on Ankle Contracture and Muscle Atrophy in Mechanically Ventilated Patients: A Pilot Study

Acronym: CPM-ICU

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Jun 29, 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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