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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPM Intervention Group | Experimental | All participants received continuous passive motion (CPM) therapy on the left ankle once daily for 7 consecutive days during mechanical ventilation. The right ankle served as the within-subject control with no intervention. This single-arm study used a within-subject control design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Passive Ankle Dorsiflexion Range of Motion (ROM) | 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 (°). | Baseline and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Tibialis Anterior Muscle Thickness | 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). | Baseline and Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-su Memorial Hospital | Taipei | Taiwan | 116 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41035043 | Derived | Lin CC, Lin YJ, Wang HC, Hsu WC. Continuous passive motion for prevention of ankle contracture and muscle loss in mechanically ventilated ICU patients. BMC Res Notes. 2025 Oct 1;18(1):409. doi: 10.1186/s13104-025-07457-z. |
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The individual participant data (IPD) will not be shared due to the small sample size and the risk of re-identification, especially in a critically ill ICU population. The study was not designed with data sharing infrastructure in place.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D015915 | Motion Therapy, Continuous Passive |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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.
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| Tibialis Anterior Muscle Cross-section Area |
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). |
| Baseline and Day 7 |
| Tibialis Anterior Muscle Pennation Angle | 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 (°). | Baseline and Day 7 |
| Tibialis Anterior Muscle Echointensity | 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). | Baseline and Day 7 |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D026201 | Musculoskeletal Manipulations |