Clinical trial NCT06944431: Using Continuous Passive Motion to Prevent Ankle Problems in ICU Patients
Official title: Application of Continuous Passive Motion to Prevent Ankle Contracture and Muscle Loss in the Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Contracture
Mechanical Ventilation
ICU-acquired Weakness
Critical Illness
Muscle Atrophy
Keywords: continuous passive motion
ankle joint contracture
ICU-acquired weakness
mechanical ventilation
ultrasound muscle assessment
critical illness
rehabilitation
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in Passive Ankle Dorsiflexion Range of Motion (ROM)
timeFrame: Baseline and Day 7
Secondary outcomes:
measure: Tibialis Anterior Muscle Thickness
timeFrame: Baseline and Day 7
measure: Tibialis Anterior Muscle Cross-section Area
timeFrame: Baseline and Day 7
measure: Tibialis Anterior Muscle Pennation Angle
timeFrame: Baseline and Day 7
measure: Tibialis Anterior Muscle Echointensity
timeFrame: Baseline and Day 7
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Shin Kong Wu Ho-su Memorial Hospital
Study officials:
References: