Incidence and Determinants of Joint Contractures in Mechanically Ventilated ICU Patients

NCT07339397 | Recruiting

• 1 other identifier: FSH-ICU-CONTRACTURE-2025
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Critical Illness; Mechanical Ventilation; INTANSIVE CARE; Joint Contractures

Keywords

Joint contracture; Intensive care unit; Mechanical ventilation; Passive range of motion; Musculoskeletal complications; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From ICU admission to the first documented detection of joint contracture, ICU discharge, or death, whichever occurs first, assessed for up to 28 days.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Study Sites (1)

Fethi Sekin City Hospital

Elâzığ, Elaziğ, 23050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sevim F Şenol Karataş, MD, PhD

CONTACT

05325736611; drsevimkaratas@gmail.com

Sevim Şenol Karataş, MD

CONTACT

+905325736611; drsevimkaratas@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 14, 2026
• Study Start: December 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)