Critical Illness, ICU-acquired Weakness, Joint Contracture, Mechanical Ventilation, Muscle Atrophy
Conditions
Keywords
continuous passive motion, ankle joint contracture, ICU-acquired weakness, mechanical ventilation, ultrasound muscle assessment, critical illness, rehabilitation
Brief summary
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
Interventions
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
Sponsors
Shin Kong Wu Ho-Su Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a within-subject controlled study using a single-group assignment model. Each participant received continuous passive motion (CPM) therapy on the left ankle (intervention side), while the right ankle served as the control without CPM. This design allows for internal comparison within the same individual.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Passive Ankle Dorsiflexion Range of Motion (ROM) | 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
| Measure | Time frame | Description |
|---|---|---|
| Tibialis Anterior Muscle Thickness | 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). |
| Tibialis Anterior Muscle Cross-section Area | 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). |
| Tibialis Anterior Muscle Pennation Angle | 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 (°). |
| Tibialis Anterior Muscle Echointensity | 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). |
Countries
Taiwan
Outcome results
None listed