跳至主要内容
临床试验/NCT07032051
NCT07032051尚未招募不适用

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

Shin Kong Wu Ho-Su Memorial Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
2
主要终点
Change in Passive Ankle Dorsiflexion Range of Motion (ROM)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in Passive Ankle Dorsiflexion Range of Motion (ROM)

时间窗: 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 (°).

次要结局

  • Tibialis Anterior Muscle Thickness(Baseline and Day 7)
  • Tibialis Anterior Muscle Cross-section Area(Baseline and Day 7)
  • Tibialis Anterior Muscle Echointensity(Baseline and Day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验