Using Continuous Passive Motion to Prevent Ankle Problems in ICU Patients (NCT06944431) | Clinical Trial Compass
CompletedNot Applicable
Using Continuous Passive Motion to Prevent Ankle Problems in ICU Patients
Taiwan12 participantsStarted 2024-11-20
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a device called Continuous Passive Motion to move the ankle automatically while patients were on a ventilator in the ICU — if my loved one is on a ventilator or at risk of ICU-acquired weakness, is this kind of passive movement something that could be part of their care plan?
2The trial focused on preventing ankle stiffness and loss of range of motion, which are common problems after a long ICU stay — how likely is my family member to develop these issues, and what is currently being done to prevent them?
3Since this trial is already completed, have the results been published or shared, and if so, what did they find about whether the device actually helped maintain ankle movement compared to standard care?
4This study was listed as Phase NA, meaning it was likely a feasibility or device-testing study rather than a large effectiveness trial — does that mean there is still uncertainty about whether this approach is proven to work, or is there enough evidence to consider it now?
5Joint contracture and muscle atrophy can seriously affect a patient's recovery and ability to walk after leaving the ICU — what rehabilitation strategies are currently available to address these risks, and how does passive motion therapy fit alongside those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Passive Ankle Dorsiflexion Range of Motion (ROM)