Fethi Sekin City Hospital
Elâzığ, Elaziğ, 23050, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07339397
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Elâzığ, Elaziğ, 23050, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time (in days) from ICU admission to the first detection of joint contracture.
Contact information is provided by the study sponsor or research team.
Sevim F Şenol Karataş, MD, PhD
CONTACT
Sevim Şenol Karataş, MD
CONTACT
Elazıg Fethi Sekin Sehir Hastanesi
Other
Incidence and Determinants of Joint Contractures in Mechanically Ventilated Intensive Care Unit Patients: a Prospective Cohort Study
Acronym: ICU-CONTRACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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