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

NCT07032051 | Not Yet Recruiting

• 2 other identifiers: CPM-SKH-20240808R20240808R
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankle Contracture; Critically Ill Intensive Care Unit Patients; Muscle Atrophy

Keywords

ICU-acquired weakness; muscle ultrasound; ankle contracture; continuous passive motion,

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 or until ICU discharge

Secondary Outcomes (3)

• Tibialis Anterior Muscle Thickness

  Baseline and Day 7

• Tibialis Anterior Muscle Cross-section Area

  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 seven consecutive days during mechanical ventilation. The right ankle, which did not receive CPM, served as the within-subject control. This single-arm trial employed a within-subject controlled design to allow direct comparison between the treated and untreated limbs in the same individual.

Device: Continuous Passive Motion

Interventions

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.

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:

• \- Eligible participants were adults (≥18 years) with acute respiratory failure expected to require mechanical ventilation for \>5 days.

You may not qualify if:

• Neuromuscular disorders
• Recent lower limb surgery or trauma
• Critical limb ischemia
• Limb amputation
• Deep vein thrombosis
• Significant leg wounds
• Pregnancy.

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-su Memorial Hospital

Taipei City, Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Motion Therapy, Continuous Passive

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

CHEN-CHUN LIN, MD

CONTACT

+886960032062; m002186@ms.skh.org.tw

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 study uses a within-subject controlled design with a single-group assignment model. Each participant receives continuous passive motion (CPM) therapy on the left ankle, while the right ankle, without CPM, serves as the control. This approach enables direct comparison of outcomes between the intervention and control conditions within the same individual.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 22, 2025
• Study Start: June 25, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)