Joint ContractureNCT06944431
Using Continuous Passive Motion to Prevent Ankle Problems in ICU Patients
A study testing Continuous Passive Motion (CPM) in people with Joint Contracture and Mechanical Ventilation, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Contracture, Mechanical Ventilation, ICU-acquired Weakness
- What is being tested?
- Continuous Passive Motion (CPM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Nov 2024to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Continuous Passive Motion to Prevent Ankle Contracture and Muscle Loss in the Mechanically Ventilated Patients
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?
Read more
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
- Being tested
- Continuous Passive Motion (CPM)
- Keywords
- continuous passive motion, ankle joint contracture, ICU-acquired weakness, mechanical ventilation, ultrasound muscle assessment, critical illness, rehabilitation
- Medical subject headings
- Critical Illness, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| 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 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. Receives: Device: Continuous Passive Motion (CPM) |
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
Secondary outcomes (4)
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 Pennation Angle
Change in pennation angle of the tibialis anterior muscle as measured from B-mode ultrasound images. Angle will be calculated using ImageJ software from the fascicle orientation relative to the deep aponeurosis. Reported in degrees (°).
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 posted25 Apr 2025
- Study start20 Nov 2024
- Primary completion24 Feb 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Joint 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 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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
- NCT06944431
- Sponsor's protocol ID
- SKH-IRB-20240808R
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to the small sample size and the risk of re-identification, especially in a critically ill ICU population. The study was not designed with data sharing infrastructure in place.
Publications
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.
PubMed 41035043
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Continuous Passive Motion to Prevent Ankle Contracture and Muscle Loss in the Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06944431
- Acronym / sponsor ID
- SKH-IRB-20240808R
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 25 Apr 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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| CPM Intervention Group | Experimental | Device: Continuous Passive Motion (CPM)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 Motion (CPM)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 | Device | CPM Intervention Group |
Primary outcome
Change in Passive Ankle Dorsiflexion Range of Motion (ROM)
Time frame: Baseline and Day 7
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 (°).
4 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 Pennation Angle
Time frame: Baseline and Day 7
Tibialis Anterior Muscle Echointensity
Time frame: Baseline and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Derived from this study: PubMed 41035043Lin 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.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to the small sample size and the risk of re-identification, especially in a critically ill ICU population. The study was not designed with data sharing infrastructure in place.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (CPM) in people with Joint Contracture and Mechanical Ventilation, 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 6 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: finished, as of the sponsor's last update on 25 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06944431, which also lists 1 linked publication.
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 25 Apr 2025.