Continuous Passive Motion to Prevent Ankle Contracture and Muscle Atrophy in Ventilated Patients (NCT07032051) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Continuous Passive Motion to Prevent Ankle Contracture and Muscle Atrophy in Ventilated Patients
Taiwan20 participantsStarted 2025-06-25
Plain-language summary
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.
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:
\- Eligible participants were adults (≥18 years) with acute respiratory failure expected to require mechanical ventilation for \>5 days.
Exclusion Criteria:
* Neuromuscular disorders
* Recent lower limb surgery or trauma
* Critical limb ischemia
* Limb amputation
* Deep vein thrombosis
* Significant leg wounds
* 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 uses a device called continuous passive motion on the ankle to try to prevent stiffness and muscle loss in ICU patients on ventilators — is this something worth considering for my loved one's situation, or are there standard care approaches already being used in the ICU that serve the same purpose?
2Since this trial is listed as 'not yet recruiting,' what's the realistic timeline before it actually starts enrolling patients, and would waiting for it delay any other care or rehabilitation that should begin right away?
3The trial is measuring changes in ankle range of motion as its main outcome — but how does preventing ankle contracture fit into the bigger picture of recovery for someone who has been on a ventilator, and what other muscle or mobility problems should we be focused on?
4Because this study is in Phase NA, meaning it's a device or procedure trial rather than a drug trial, what do we already know about the safety of continuous passive motion devices for critically ill patients, and are there any risks specific to someone in the ICU on a ventilator?
5If this trial isn't available yet or my loved one doesn't end up being a candidate, what alternatives — like physical therapy, positioning, or other early mobility protocols — are currently being used in the ICU to prevent the same kind of muscle loss and joint stiffness this study is trying to address?
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)
Timeframe: Baseline and Day 7 or until ICU discharge