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Recruiting NCT07339397

NCT07339397 Incidence and Determinants of Joint Contractures in Mechanically Ventilated ICU Patients

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Clinical Trial Summary
NCT ID NCT07339397
Status Recruiting
Phase
Sponsor Elazıg Fethi Sekin Sehir Hastanesi
Condition Joint Contractures
Study Type OBSERVATIONAL
Enrollment 150 participants
Start Date 2025-12-01
Primary Completion 2026-05-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 150 participants in total. It began in 2025-12-01 with a primary completion date of 2026-05-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

Inclusion Criteria: * • 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 Exclusion Criteria: * • 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

Contact & Investigator

Central Contact

Sevim F Şenol Karataş, MD, PhD

✉ drsevimkaratas@gmail.com

📞 05325736611

Frequently Asked Questions

Who can join the NCT07339397 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Joint Contractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07339397 currently recruiting?

Yes, NCT07339397 is actively recruiting participants. Contact the research team at drsevimkaratas@gmail.com for enrollment information.

Where is the NCT07339397 trial being conducted?

This trial is being conducted at Elâzığ, Turkey (Türkiye).

Who is sponsoring the NCT07339397 clinical trial?

NCT07339397 is sponsored by Elazıg Fethi Sekin Sehir Hastanesi. The trial plans to enroll 150 participants.

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