ClinicalTrials.gg
CompletedNCT06944431Updated Apr 25, 2025

Using Continuous Passive Motion to Prevent Ankle Problems in ICU Patients

An interventional study of Continuous Passive Motion (CPM) in Joint Contracture, Mechanical Ventilation and ICU-acquired Weakness, sponsored by Shin Kong Wu Ho-Su Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-25.

Primary conditionMuscular AtrophyRegistry: Critical IllnessReclassifiedWhy we changed it
Registry
Critical Illness — the first condition term the registry derived for this study.
ClinicalTrials.gg
Muscular Atrophy
Why
  1. Critical Illness is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Muscular Atrophy.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Shin Kong Wu Ho-Su Memorial Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Muscular Atrophy with a site in Taiwan — 1 open to participants now, 3 under way, 1 of them phase 3. Muscular Atrophy · Taiwan.

Enrollment
22nd of 22
12 · median 100
Started
2024
the only one that year
No phase
13 of 23
1 open now
Registered
21st of 23
by date
Lead sponsor
2 of 23
Shin Kong Wu Ho-Su Memorial Hospital

Among the 23 studies in Muscular Atrophy with a site in Taiwan, this one is the 22nd largest by enrollment of the 22 interventional ones that give a count, is the only one that started in 2024, is one of 13 with no phase, and was the 21st registered.

Muscular Atrophy

413 studies on the registry are indexed under Muscular Atrophy; 77 are open to participants now.

Browse Muscular Atrophy studies →

Open to participants now

1 of the 23 studies in Muscular Atrophy with a site in Taiwan is open now. Recruiting first, the newest first:

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 51 Muscular Atrophy studies recruiting now, 25 (49%) set no upper age limit and 12 (24%) stop at 75 or younger; 4 take children under 18; 16 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 23 studies in Muscular Atrophy with a site in Taiwan, or all of them as a file.
02

Study 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

03

Conditions studied

  • Joint Contracture
  • Mechanical Ventilation
  • ICU-acquired Weakness
  • Critical Illness
  • Muscle Atrophy

Browse trials for

Keywords

  • continuous passive motion
  • ankle joint contracture
  • ICU-acquired weakness
  • mechanical ventilation
  • ultrasound muscle assessment
  • critical illness
  • rehabilitation
04

In context

Muscular Atrophy Reclassified

413 studies on the registry are indexed under Muscular Atrophy; 77 are open to participants now.

This study's enrollment of 12 is below the median of 40 across 327 interventional studies indexed under Muscular Atrophy.

Browse Muscular Atrophy studies →

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital is the lead sponsor of 65 studies on the registry; 16 are open to participants now.

Compared within Muscular Atrophy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for passive ankle movement
  • obtained from legal representative

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    CPM Intervention Group

    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

  • DeviceContinuous 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

07

What researchers measure

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 (°).

    Time frame: Baseline and Day 7

Secondary outcomes

  1. 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).

    Time frame: Baseline and Day 7

  2. 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).

    Time frame: Baseline and Day 7

  3. 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 (°).

    Time frame: Baseline and Day 7

  4. 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).

    Time frame: Baseline and Day 7

08

Study locations

1 site
  • Shin Kong Wu Ho-su Memorial Hospital
    Taipei City, 116, Taiwan
09

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2024 to primary completion in Feb 2025, 3 months.

Of 169 non-industry interventional studies with no phase under Muscular Atrophy, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's 3 months is below that.

Counting every sponsor, half of 175 studies reached it within 21 months; a quarter within 9 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2025
First posted
Apr 25, 2025
StartActual
Nov 20, 2024
Primary completionActual
Feb 24, 2025
CompletionActual
Mar 14, 2025
Last update
Apr 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06944431
Lead sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Responsible party
Sponsor
First posted
Apr 25, 2025
Start date
Nov 20, 2024
Primary completion
Feb 24, 2025
Completion
Mar 14, 2025
Last update
Apr 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion