Ankle ContractureCPM-ICUNCT07032051
Continuous Passive Motion to Prevent Ankle Contracture and Muscle Atrophy in Ventilated Patients
A study testing Continuous Passive Motion in people with Ankle Contracture and Critically Ill Intensive Care Unit Patients, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Contracture, Critically Ill Intensive Care Unit Patients, Muscle Atrophy
- What is being tested?
- Continuous Passive Motion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants were adults (≥18 years) with acute respiratory failure expected to require mechanical ventilation for >5 days.
Who cannot join
- Neuromuscular disorders
- Recent lower limb surgery or trauma
- Critical limb ischemia
- Limb amputation
- Deep vein thrombosis
- Significant leg wounds
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Shin Kong Wu Ho-su Memorial Hospital
Taipei City, Taipei, 116
CHEN-CHUN LIN, MD, +886960032062, m002186@ms.skh.org.tw
About this study
Official title: Preventive Effects of Continuous Passive Motion on Ankle Contracture and Muscle Atrophy in Mechanically Ventilated Patients: A Pilot Study
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:
Read more
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.
Read the detailed description
Critically ill patients commonly experience neuromuscular complications, notably intensive care unit-acquired weakness (ICU-AW) and joint contractures. ICU-AW affects up to 80% of patients requiring prolonged mechanical ventilation and is associated with prolonged hospitalization, delayed functional recovery, and increased mortality. Concurrently, immobility during ICU stays contributes significantly to joint contractures, affecting approximately one-third of patients experiencing extended ICU admissions. Among these complications, ankle joint plantar-flexion contractures (foot drop) are particularly debilitating, severely impacting patients' balance, gait retraining, and overall functional recovery after ICU discharge.
Although early mobilization is widely recognized as beneficial, leading to reduced ICU stays, lower incidence of delirium, preservation of muscle integrity, and enhanced quality of life post-discharge, its implementation remains challenging. Many critically ill patients are unable to participate in early active mobilization due to sedation, hemodynamic instability, or other medical contraindications. Furthermore, evidence suggests that early mobilization might carry increased risks of adverse events for certain patient populations. Thus, alternative strategies are essential for patients unsuitable for early active rehabilitation, emphasizing preservation of joint mobility and muscle integrity to facilitate future rehabilitation opportunities.
Continuous passive motion (CPM) therapy has emerged as a viable intervention designed initially for postoperative orthopedic rehabilitation. CPM passively moves joints through a controlled range, potentially maintaining flexibility by inhibiting periarticular collagen cross-linking, preserving soft tissue extensibility, and maintaining muscle-tendon compliance. However, its effectiveness in critical illness settings remains uncertain, with limited evidence suggesting potential benefits in reducing muscle atrophy, such as that of the tibialis anterior muscle, in ICU patients unable to actively mobilize, while other studies have reported minimal effects. Thus, rigorous evaluation of CPM's impact on joint mobility preservation and muscle atrophy prevention is warranted.
This study aimed to evaluate whether CPM therapy effectively mitigates passive range of motion (PROM) loss at the ankle joint in sedated, mechanically ventilated ICU patients. Additionally, muscle structural changes were assessed via ultrasound imaging to determine if CPM influences muscle morphology compared to limbs receiving standard care alone. Ultrasound parameters, including muscle thickness (MT), cross-sectional area (CSA), echointensity (EI), and pennation angle (PA), were used to comprehensively monitor morphological changes and provide insights into the functional implications of observed alterations.
- Being tested
- Continuous Passive Motion
- Keywords
- ICU-acquired weakness, muscle ultrasound, ankle contracture, continuous passive motion,
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Passive MotionDevice
Continuous passive motion was applied to the left ankle joint for 30 minutes twice a day using a motorized CPM device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous Passive Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (°).
Measured: Baseline and Day 7 or until ICU discharge
Secondary outcomes (3)
Tibialis Anterior Muscle Thickness
Change in muscle thickness of the tibialis anterior as measured by ultrasound. Measurements will be obtained directly from B-mode ultrasound images using the built-in caliper function of the ultrasound machine. Values will be reported in centimeters (cm).
Measured: Baseline and Day 7
Tibialis Anterior Muscle Cross-section Area
Change in cross-sectional area of the tibialis anterior muscle as measured by ultrasound. Measurements will be obtained directly using the built-in area tracing tool on the ultrasound machine during B-mode imaging. Values will be reported in square centimeters (cm²).
Measured: Baseline and Day 7
Tibialis Anterior Muscle Echointensity
Change in echointensity of the tibialis anterior muscle as measured from B-mode ultrasound images. Echointensity will be quantified using ImageJ software as the mean and standard deviation of grayscale values within a manually selected region of interest (ROI), ranging from 0 (black) to 255 (white). Reported in grayscale arbitrary units (AU).
Measured: Baseline and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start25 Jun 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032051
- Sponsor's protocol ID
- CPM-SKH-20240808R
- Other IDs
- 20240808R
- Acronym
- CPM-ICU
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effects of Continuous Passive Motion on Ankle Contracture and Muscle Atrophy in Mechanically Ventilated Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT07032051
- Acronym / sponsor ID
- CPM-ICU / CPM-SKH-20240808R
- Keywords
- ICU-acquired weakness, muscle ultrasound, ankle contracture, continuous passive motion,
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Critically ill patients commonly experience neuromuscular complications, notably intensive care unit-acquired weakness (ICU-AW) and joint contractures. ICU-AW affects up to 80% of patients requiring prolonged mechanical ventilation and is associated with prolonged hospitalization, delayed functional recovery, and increased mortality. Concurrently, immobility during ICU stays contributes significantly to joint contractures, affecting approximately one-third of patients experiencing extended ICU admissions. Among these complications, ankle joint plantar-flexion contractures (foot drop) are particularly debilitating, severely impacting patients' balance, gait retraining, and overall functional recovery after ICU discharge.
Although early mobilization is widely recognized as beneficial, leading to reduced ICU stays, lower incidence of delirium, preservation of muscle integrity, and enhanced quality of life post-discharge, its implementation remains challenging. Many critically ill patients are unable to participate in early active mobilization due to sedation, hemodynamic instability, or other medical contraindications. Furthermore, evidence suggests that early mobilization might carry increased risks of adverse events for certain patient populations. Thus, alternative strategies are essential for patients unsuitable for early active rehabilitation, emphasizing preservation of joint mobility and muscle integrity to facilitate future rehabilitation opportunities.
Continuous passive motion (CPM) therapy has emerged as a viable intervention designed initially for postoperative orthopedic rehabilitation. CPM passively moves joints through a controlled range, potentially maintaining flexibility by inhibiting periarticular collagen cross-linking, preserving soft tissue extensibility, and maintaining muscle-tendon compliance. However, its effectiveness in critical illness settings remains uncertain, with limited evidence suggesting potential benefits in reducing muscle atrophy, such as that of the tibialis anterior muscle, in ICU patients unable to actively mobilize, while other studies have reported minimal effects. Thus, rigorous evaluation of CPM's impact on joint mobility preservation and muscle atrophy prevention is warranted.
This study aimed to evaluate whether CPM therapy effectively mitigates passive range of motion (PROM) loss at the ankle joint in sedated, mechanically ventilated ICU patients. Additionally, muscle structural changes were assessed via ultrasound imaging to determine if CPM influences muscle morphology compared to limbs receiving standard care alone. Ultrasound parameters, including muscle thickness (MT), cross-sectional area (CSA), echointensity (EI), and pennation angle (PA), were used to comprehensively monitor morphological changes and provide insights into the functional implications of observed alterations.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CPM Intervention Group | Experimental | Device: Continuous Passive MotionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants were adults (≥18 years) with acute respiratory failure expected to require mechanical ventilation for >5 days.
Key exclusion criteria (7 listed)
- Neuromuscular disorders
- Recent lower limb surgery or trauma
- Critical limb ischemia
- Limb amputation
- Deep vein thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Passive MotionContinuous passive motion was applied to the left ankle joint for 30 minutes twice a day using a motorized CPM device. | Device | CPM Intervention Group |
Primary outcome
Change in Passive Ankle Dorsiflexion Range of Motion (ROM)
Time frame: Baseline and Day 7 or until ICU discharge
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 (°).
3 secondary outcomes
Tibialis Anterior Muscle Thickness
Time frame: Baseline and Day 7
Tibialis Anterior Muscle Cross-section Area
Time frame: Baseline and Day 7
Tibialis Anterior Muscle Echointensity
Time frame: Baseline and Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Passive Motion in people with Ankle Contracture and Critically Ill Intensive Care Unit Patients, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHEN-CHUN LIN, MD (+886960032062, m002186@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Passive Ankle Dorsiflexion Range of Motion (ROM) (time frame: Baseline and Day 7 or until ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.