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

NCT ID: NCT07032051

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Ankle Contracture; Critically Ill Intensive Care Unit Patients; Muscle Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CPM Intervention Group

All participants received continuous passive motion (CPM) therapy on the left ankle once daily for seven consecutive days during mechanical ventilation. The right ankle, which did not receive CPM, served as the within-subject control. This single-arm trial employed a within-subject controlled design to allow direct comparison between the treated and untreated limbs in the same individual.

Group Type: EXPERIMENTAL

Continuous Passive Motion

Intervention Type: DEVICE

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

Interventions

Continuous Passive Motion

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shin Kong Wu Ho-su Memorial Hospital

Taipei City, Taipei, Taiwan

Countries

Taiwan

Central Contacts

CHEN-CHUN LIN, MD

Role: CONTACT

m002186@ms.skh.org.tw

+886960032062

Facility Contacts

CHEN-CHUN LIN, MD

Role: primary

m002186@ms.skh.org.tw

+886960032062

Other Identifiers

20240808R

Identifier Type: OTHER

Identifier Source: secondary_id

CPM-SKH-20240808R

Identifier Type: -

Identifier Source: org_study_id