Health TrialsbyHealthPanel

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

ConditionsAnkle ContractureCritically Ill Intensive Care Unit PatientsMuscle Atrophy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShin Kong Wu Ho-Su Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Neuromuscular disorders

Recent lower limb surgery or trauma

Critical limb ischemia

Limb amputation

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: CPM Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 (°).

Time frame
Baseline and Day 7 or until ICU discharge

Secondary outcomes

1

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).

Time frame
Baseline and Day 7
2

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).

Time frame
Baseline and Day 7
3

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).

Time frame
Baseline and Day 7

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Shin Kong Wu Ho-su Memorial Hospital Status unavailable 116, Taipei City, TaipeiTaiwanTaiwan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shin Kong Wu Ho-Su Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: