Predictive Algorithms for Critical Rehabilitation Outcomes

April 15, 2026 updated by: Qing Shu, Wuhan University

Development and Validation of a Prediction Algorithms to Estimate the Clinical Effect of Early Rehabilitation on ICU Survivors Received Mechanical Ventilation in the ICU

An increasing amount of evidence from evidence-based medicine indicates that early rehabilitation intervention for patients receiving mechanical ventilation is safe and feasible, and can promote functional recovery and reduce hospital stay. However, the conscious state, respiratory function, and daily living activities of these patients after being discharged from the ICU vary greatly, and some patients do not show obvious benefits. How to identify which patients may have benefit from early rehabilitation is a key issue that needs to be addressed in critical care rehabilitation. This study aims to investigate the clinical data related to the disease of the ICU survivors who received mechanical ventilation as the research object, by collecting their clinical data when receiving early rehabilitation intervention, and constructing a clinical prediction model for the efficacy of early rehabilitation intervention in the ICU through the selection of optimal regression equation or machine learning algorithm. The application of this model can effectively determine whether ICU inpatients need early rehabilitation intervention, thereby reducing complication rates and improving their quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

An increasing amount of evidence from evidence-based medicine suggests that early rehabilitation intervention (including early active and passive exercises, position management, pulmonary rehabilitation, etc.) for mechanical ventilation patients is safe and feasible, and can promote certain degree of functional recovery and reduce the length of stay in the intensive care unit (ICU). However, the differences in consciousness state, muscle strength, respiratory function, and activity of daily living (ADL) among patients who are discharged from the ICU after condition stabilization are very large, even some patients did not obtain obvious benefits. Therefore, how to identify which patients may have better benefit from early rehabilitation intervention is a key issue that needs to be focused on in ICU.

This study used "Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD)" as the guideline. Survivors undergoing mechanical ventilation in the ICU were recruited as the participants, whether patients gained progress in ADL function at different time points after receiving early rehabilitation intervention in the ICU was used as the outcome which is a time-to-event indicator. Demographic data, clinical diagnostic data and disease intervention data of the subjects were collected as alternative predictors. Variable transformation and variable screening were used to find predictors that could predict the outcome. The process of constructing clinical predictive models is completed by fitting models through regression equations and machine learning algorithms, internal validation, external validation, and clinical value assessment. The model with the best prediction efficiency is selected based on the differentiation and calibration of different models after validation. This model will be presented with a nomogram or a web app. The application of this clinical predictive model will identify whether and when this patient can received better recovery on ADL after receiving early rehabilitation intervention, so as to further optimize the timing of early intervention in rehabilitation and improve his survival quality.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430070
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

ICU patients received mechanical ventilation and early rehabilitation interventions, regardless of the primary diagnosis.

Description

Inclusion Criteria:

  1. Age older than 18 years;
  2. Received mechanical ventilation, including endotracheal intubation and tracheostomy, during ICU admission;
  3. Met the rehabilitation intervention indications outlined in the "Chinese Expert Consensus on Neurocritical Rehabilitation" during ICU admission and underwent corresponding early rehabilitation interventions, including but not limited to arousal therapy for consciousness disorders, early active/passive mobilization, comprehensive pulmonary rehabilitation, etc.;
  4. No mortality events occurred during ICU admission;
  5. Informed consent form signed by family members or the patient.

Exclusion Criteria:

  1. Pediatric patients under 18 years of age;
  2. Hospitalized patients in the ICU who did not receive mechanical ventilation;
  3. Patients in the ICU who did not undergo early rehabilitation interventions;
  4. mortality events occurred during ICU admission;
  5. Patients transferred out of the ICU due to treatment abandonment by family members;
  6. Family refusal to sign the informed consent form or patient refusal to sign the informed consent form when conscious and competent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Survivors of ICU with Mechanical Ventilation
Survivors of ICU with Mechanical Ventilation are individuals who have been treated in an intensive care unit (ICU) and require the use of a mechanical ventilator to assist their breathing with no mortality events occurring.
Other: Early rehabilitation intervention
Based on the indications for early rehabilitation intervention outlined in the "Chinese Expert Consensus on Neurological Critical Care Rehabilitation," early rehabilitation interventions are categorized into three stages according to the patient's consciousness level (GCS score), degree of cooperation (S5Q score), and sedation status (RASS score)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence Measure (FIM) scale
Time Frame: From date of enrollment until the date of ADL improvement (FIM increase ≥ 5) or date of participants are transferred out of the ICU. FIM score was assessed every other day after treatment starts and up to 6 weeks.

The Functional Independence Measure (FIM) scale is a widely used tool designed to assess an individual's level of disability and functional independence in activities of daily living (ADLs).

The FIM scale consists of 18 items divided into two main categories: **self-care** and **mobility**, each evaluating specific tasks such as eating, bathing, dressing, and transferring. Each item is scored on a scale from 1 to 7, where:

  • 1 indicates total dependence (the individual requires assistance),
  • 7 indicates complete independence (the individual performs the task safely and independently).

The total FIM score can range from 18 to 126, with higher scores representing greater functional independence levels.
From date of enrollment until the date of ADL improvement (FIM increase ≥ 5) or date of participants are transferred out of the ICU. FIM score was assessed every other day after treatment starts and up to 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan University

Collaborators

General Hospital of the Yangtze River Shipping/Wuhan Brain Hospital
Wuchang Hospital Affiliated to Wuhan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ZNYYIIT2024004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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