Joint ContracturesICU-CONTRACTNCT07339397
Incidence and Determinants of Joint Contractures in Mechanically Ventilated ICU Patients
An observational study of Joint Contractures and Critical Illness, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study aims to evaluate the incidence and determinants of joint contracture development in mechanically ventilated adult patients admitted to the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Contractures, Critical Illness, Mechanical Ventilation
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 May 2026
- Phase
- Observational
- 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
Study population: The study population consists of adult patients admitted to a tertiary-level intensive care unit who are mechanically ventilated, immobilized, and have impaired consciousness. Eligible participants are patients aged 18 years or older who are expected to remain in the ICU for at least seven days and are unable to mobilize independently due to their clinical condition. Patients with pre-existing joint contractures, neuromuscular diseases, spasticity, amputations, or conditions that preclude safe assessment of joint range of motion are excluded. All participants receive routine ICU care and standard physiotherapy according to institutional protocols, and no additional interventions are introduced for research purposes.
Who may be able to join
- • Adult patients aged 18 and over
- Patients on mechanical ventilation and monitored in the intensive care unit for at least 7 days
- Glasgow Coma Score ≤10
- Patients monitored immobile in the intensive care unit
- Situations where informed consent can be obtained from the patient's legal representative
Who cannot join
- • Presence of pre-existing joint contracture, ankylosis, or amputation
- Patients with severe burns, fractures, or surgical reasons preventing joint movement
- Patients with a history of neuromuscular disease or spasticity
- Patients who were immobilized for ≥1 week prior to admission to the intensive care unit
- Hemodynamic instability situations where measurement is unreliable
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fethi Sekin City Hospital
Elâzığ, Elaziğ, 23050
About this study
Official title: Incidence and Determinants of Joint Contractures in Mechanically Ventilated Intensive Care Unit Patients: a Prospective Cohort Study
This prospective observational cohort study aims to evaluate the incidence and determinants of joint contracture development in mechanically ventilated adult patients admitted to the intensive care unit (ICU). Prolonged immobilization, deep sedation, and neuromuscular blockade are common in critically ill patients and may contribute to musculoskeletal complications, including joint contractures, which can adversely affect functional outcomes and rehabilitation after ICU discharge.
Adult patients who are mechanically ventilated, immobilized, and have impaired consciousness will be consecutively enrolled and followed during their ICU stay. Joint range of motion will be assessed using standardized passive range of motion (PROM) measurements performed with a goniometer at predefined intervals by trained assessors. Joint contracture will be defined as a reduction of at least 33% in passive joint range of motion compared with normal reference values.
Read more
This study is non-interventional, and all patients will receive routine ICU care and standard physiotherapy according to institutional protocols. No additional procedures or interventions will be applied for research purposes. Demographic characteristics, clinical variables, and ICU-related factors will be recorded to explore potential associations with contracture development.
The findings of this study are expected to provide prospective data on the burden of joint contractures in mechanically ventilated ICU patients and to identify modifiable risk factors that may inform future preventive and rehabilitative strategies in critical care practice.
Read the detailed description
This study is designed as a prospective, non-interventional observational cohort study conducted in a tertiary-level intensive care unit (ICU). The primary objective is to determine the incidence of newly developed joint contractures and to identify clinical and ICU-related factors associated with contracture development in mechanically ventilated adult patients.
Adult patients (≥18 years) who are mechanically ventilated, immobilized, and have impaired consciousness will be consecutively enrolled within the first 48 hours of ICU admission. Patients will be followed throughout their ICU stay. Individuals with pre-existing joint contractures, amputations, neuromuscular diseases, spasticity, or conditions preventing safe joint assessment will be excluded.
Joint range of motion will be evaluated using standardized passive range of motion (PROM) measurements performed with a goniometer. Measurements will be conducted at predefined intervals, twice weekly, by trained physiotherapists or physical medicine specialists. The same evaluator and consistent time windows will be used whenever possible to ensure measurement reliability. Joint contracture will be defined as a reduction of at least 33% in passive joint range of motion compared with established normal reference values.
All patients will receive routine ICU care, including standard physiotherapy practices such as positioning, passive or active-assisted joint exercises, respiratory physiotherapy, and early mobilization when clinically appropriate. No additional interventions, treatments, or procedures will be introduced for research purposes.
Demographic data, clinical characteristics, and ICU-related variables-including duration of mechanical ventilation, length of ICU stay, sedation duration, use of neuromuscular blocking agents, timing of mobilization, severity scores, and clinical outcomes-will be prospectively recorded.
Descriptive statistics will be used to summarize patient characteristics and contracture incidence. Comparative analyses will be performed between patients with and without joint contracture development. Multivariable regression models will be used to explore independent factors associated with contracture development. Time-to-event analyses may be applied to evaluate the timing of contracture occurrence during the ICU stay.
The results of this study are expected to provide robust prospective data on the burden and determinants of joint contractures in mechanically ventilated ICU patients, thereby contributing to improved preventive and rehabilitative strategies in critical care.
- Keywords
- Joint contracture, Intensive care unit, Mechanical ventilation, Passive range of motion, Musculoskeletal complications, Physiotherapy
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically Ventilated ICU Patients | Adult patients admitted to the intensive care unit who are mechanically ventilated, immobilized, and have impaired consciousness. All participants will receive routine ICU care and standard physiotherapy according to institutional protocols. No additional interventions or experimental procedures will be applied as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Joint Contracture During ICU Stay
Development of a new joint contracture, defined as a ≥33% reduction in passive range of motion (PROM) compared with normal reference values, measured using a goniometer.
Measured: From ICU admission to ICU discharge or death, whichever occurs first, assessed prospectively for up to 28 days of ICU stay.
Secondary outcomes (1)
Time to Joint Contracture Development
Time (in days) from ICU admission to the first detection of joint contracture.
Measured: From ICU admission to the first documented detection of joint contracture, ICU discharge, or death, whichever occurs first, assessed for up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Dec 2025
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint ContracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oğuz Kağan Bulut, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339397
- Sponsor's protocol ID
- FSH-ICU-CONTRACTURE-2025
- Acronym
- ICU-CONTRACT
- Status last verified
- Sep 2026
- First submitted
- 2 Jan 2026
- Last updated
- 10 Sep 2026
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Determinants of Joint Contractures in Mechanically Ventilated Intensive Care Unit Patients: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07339397
- Acronym / sponsor ID
- ICU-CONTRACT / FSH-ICU-CONTRACTURE-2025
- Keywords
- Joint contracture, Intensive care unit, Mechanical ventilation, Passive range of motion, Musculoskeletal complications, Physiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 14 Jan 2026 (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 prospective observational cohort study aims to evaluate the incidence and determinants of joint contracture development in mechanically ventilated adult patients admitted to the intensive care unit (ICU). Prolonged immobilization, deep sedation, and neuromuscular blockade are common in critically ill patients and may contribute to musculoskeletal complications, including joint contractures, which can adversely affect functional outcomes and rehabilitation after ICU discharge.
Adult patients who are mechanically ventilated, immobilized, and have impaired consciousness will be consecutively enrolled and followed during their ICU stay. Joint range of motion will be assessed using standardized passive range of motion (PROM) measurements performed with a goniometer at predefined intervals by trained assessors. Joint contracture will be defined as a reduction of at least 33% in passive joint range of motion compared with normal reference values.
This study is non-interventional, and all patients will receive routine ICU care and standard physiotherapy according to institutional protocols. No additional procedures or interventions will be applied for research purposes. Demographic characteristics, clinical variables, and ICU-related factors will be recorded to explore potential associations with contracture development.
The findings of this study are expected to provide prospective data on the burden of joint contractures in mechanically ventilated ICU patients and to identify modifiable risk factors that may inform future preventive and rehabilitative strategies in critical care practice.
Detailed description
This study is designed as a prospective, non-interventional observational cohort study conducted in a tertiary-level intensive care unit (ICU). The primary objective is to determine the incidence of newly developed joint contractures and to identify clinical and ICU-related factors associated with contracture development in mechanically ventilated adult patients.
Adult patients (≥18 years) who are mechanically ventilated, immobilized, and have impaired consciousness will be consecutively enrolled within the first 48 hours of ICU admission. Patients will be followed throughout their ICU stay. Individuals with pre-existing joint contractures, amputations, neuromuscular diseases, spasticity, or conditions preventing safe joint assessment will be excluded.
Joint range of motion will be evaluated using standardized passive range of motion (PROM) measurements performed with a goniometer. Measurements will be conducted at predefined intervals, twice weekly, by trained physiotherapists or physical medicine specialists. The same evaluator and consistent time windows will be used whenever possible to ensure measurement reliability. Joint contracture will be defined as a reduction of at least 33% in passive joint range of motion compared with established normal reference values.
All patients will receive routine ICU care, including standard physiotherapy practices such as positioning, passive or active-assisted joint exercises, respiratory physiotherapy, and early mobilization when clinically appropriate. No additional interventions, treatments, or procedures will be introduced for research purposes.
Demographic data, clinical characteristics, and ICU-related variables-including duration of mechanical ventilation, length of ICU stay, sedation duration, use of neuromuscular blocking agents, timing of mobilization, severity scores, and clinical outcomes-will be prospectively recorded.
Descriptive statistics will be used to summarize patient characteristics and contracture incidence. Comparative analyses will be performed between patients with and without joint contracture development. Multivariable regression models will be used to explore independent factors associated with contracture development. Time-to-event analyses may be applied to evaluate the timing of contracture occurrence during the ICU stay.
The results of this study are expected to provide robust prospective data on the burden and determinants of joint contractures in mechanically ventilated ICU patients, thereby contributing to improved preventive and rehabilitative strategies in critical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically Ventilated ICU Patients | – | –Adult patients admitted to the intensive care unit who are mechanically ventilated, immobilized, and have impaired consciousness. All participants will receive routine ICU care and standard physiotherapy according to institutional protocols. No additional interventions or experimental procedures will be applied as part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients admitted to a tertiary-level intensive care unit who are mechanically ventilated, immobilized, and have impaired consciousness. Eligible participants are patients aged 18 years or older who are expected to remain in the ICU for at least seven days and are unable to mobilize independently due to their clinical condition. Patients with pre-existing joint contractures, neuromuscular diseases, spasticity, amputations, or conditions that preclude safe assessment of joint range of motion are excluded. All participants receive routine ICU care and standard physiotherapy according to institutional protocols, and no additional interventions are introduced for research purposes.
Key inclusion criteria (5 listed)
- • Adult patients aged 18 and over
Key exclusion criteria (5 listed)
- • Presence of pre-existing joint contracture, ankylosis, or amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Joint Contracture During ICU Stay
Time frame: From ICU admission to ICU discharge or death, whichever occurs first, assessed prospectively for up to 28 days of ICU stay.
Development of a new joint contracture, defined as a ≥33% reduction in passive range of motion (PROM) compared with normal reference values, measured using a goniometer.
1 secondary outcome
Time to Joint Contracture Development
Time frame: From ICU admission to the first documented detection of joint contracture, ICU discharge, or death, whichever occurs first, assessed for up to 28 days.
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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of Joint Contractures and Critical Illness, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 10 Sep 2026. 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 Turkey (Türkiye). 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?
Incidence of Joint Contracture During ICU Stay (time frame: From ICU admission to ICU discharge or death, whichever occurs first, assessed prospectively for up to 28 days of ICU stay.). 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 10 Sep 2026.