Using Continuous Passive Motion to Prevent Ankle Problems in ICU Patients

NCT06944431 | Completed

• 1 other identifier: SKH-IRB-20240808R
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

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 (°).

  Baseline and Day 7

Secondary Outcomes (4)

• Tibialis Anterior Muscle Thickness

  Baseline and Day 7

• Tibialis Anterior Muscle Cross-section Area

  Baseline and Day 7

• Tibialis Anterior Muscle Pennation Angle

  Baseline and Day 7

• Tibialis Anterior Muscle Echointensity

  Baseline and Day 7

Study Arms (1)

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.

Device: Continuous Passive Motion (CPM)

Interventions

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

CPM Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-su Memorial Hospital

Taipei, Taiwan, 116, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 41035043 DERIVED

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy

Interventions

Motion Therapy, Continuous Passive

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Musculoskeletal Manipulations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 25, 2025
• Study Start: November 20, 2024
• Primary Completion: February 24, 2025
• Study Completion: March 14, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)