NCT07000981

Brief Summary

The goal of this study is to develop a nursing clinical decision support system for fall risk prediction using machine learning and computer vision techniques. The system is intended to offer advantages over traditional scales, including real-time analysis, contactless monitoring, objective evaluation, and personalized risk prediction-ultimately aiming to improve patient safety and reduce complications related to falls in clinical settings. This study aims to answer the following questions: Can machine learning models serve as valid tools for fall risk prediction? Is the proposed system feasible for use in clinical environments? Inclusion criteria for participants:

  • Aged 18 years or older
  • Able to read and write in Turkish
  • Able to walk with or without assistance
  • Willing to voluntarily participate in the study Exclusion criteria:
  • Inability to speak or understand Turkish adequately
  • Being intubated
  • Being physically restrained
  • Being immobile
  • Having a diagnosed cognitive impairment Participants' basic information-including age, height, and weight-will be collected through a demographic data form. Fall risk will be initially assessed using the Morse Fall Scale. Then, a walking assessment will be conducted using a digital camera-based computer vision system as participants walk at a comfortable pace in a clinical corridor. Additionally, an accelerometer placed in the participants' pockets will record three-axis acceleration (X, Y, Z) during walking. The data obtained will be analyzed using machine learning algorithms to estimate lower and upper limb biomechanics in real time. Features such as step length, cadence, gait cycle, and range of motion (ROM) will be extracted. These features, combined with Morse Fall Scale scores, will be used to train and validate an artificial neural network (ANN). The study aims to contribute to the development of a reliable, objective, and real-time system capable of predicting fall risk in clinical environments through gait analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2025

Completed
4 months until next milestone

Results Posted

Study results publicly available

December 2, 2025

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

May 13, 2025

Results QC Date

July 24, 2025

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Fall Risk Categories Based on the Morse Fall Scale

    Assessment of the patient's fall risk with the Morse Fall Scale It is an effective and simple measurement tool that is frequently used in hospitals in Turkey and used to diagnose potential patient fall risks for the nursing profession. The scale consists of six criteria (secondary diagnosis, presence of a history of falls, mobilization support, presence of intravenous access or heparin use, gait/transfer, and mental status) that diagnose fall risk. According to this assessment tool, if the patient has a score below 25 points, he/she is in the low risk group for falls. If the score is between 25 and 50, the patient is in the medium risk group, and if the score is 51 and above, the patient is in the high risk group. A minimum score of 0 and a maximum score of 125 can be obtained from the scale. This scale allows a systematic determination of the fall risk of patients in clinical settings.

    Day 1

  • Fall Risk Classification Accuracy of the Decision Support System

    Classification accuracy of the decision support system was evaluated based on the percentage of test units correctly classified. The scale ranges from 0% to 100%, where higher values indicate better performance. This metric reflects the proportion of correctly identified cases by the system during model evaluation.

    Day 1

  • Classification Performance Metrics of the Decision Support System (F1 Score, Precision, Recall)

    This outcome measure evaluates the classification performance of a clinical decision support system using standard machine learning metrics: precision, recall, and F1-score. These metrics are based on a scale ranging from 0 to 1. Higher values indicate better classification performance. Precision is defined as the proportion of true positive predictions among all positive predictions. Recall is defined as the proportion of true positive predictions among all actual positives. The F1-score is the harmonic mean of precision and recall.

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study is planned to be conducted on patients who meet the inclusion criteria and are hospitalized in the Physical Medicine and Rehabilitation department of a research hospital located in the eastern region of Turkey.

You may qualify if:

  • years of age or older
  • Accepting voluntary participation in the study
  • Be able to read and write Turkish
  • Being able to walk with or without support

You may not qualify if:

  • Not being able to speak or understand Turkish adequately
  • Being intubated.
  • To be identified.
  • Being immobile
  • Having a mental disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turgut Özal Medical Center

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

Related Publications (7)

  • Akhtaruzzaman M, Shafie AA, Khan MR. Gait Analysis: Systems, Technologies and Significance. J Mech Med Biol. 2016;16(7).

    BACKGROUND
  • Demir NY, Intepeler ŞS. Adaptation Of Morse Fall Scale To Turkish And Determination Of Sensitivity And Specificity. J Ege Univ Nurs Fac. 2012;28(1):57-71.

    BACKGROUND
  • Zhao M, Chang CH, Xie W, Xie Z, Hu J. Cloud Shape Classification System Based on Multichannel CNN and Enhanced FDM. IEEE Access. 2020;8:44111-24.

    BACKGROUND
  • Krizhevsky A, Sutskever I, Hinton GE. ImageNet classification with deep convolutional neural networks. Commun ACM. 2017;60(6):84-90.

    BACKGROUND
  • Santos GL, Endo PT, Monteiro KHC, Rocha EDS, Silva I, Lynn T. Accelerometer-Based Human Fall Detection Using Convolutional Neural Networks. Sensors (Basel). 2019 Apr 6;19(7):1644. doi: 10.3390/s19071644.

    PMID: 30959877BACKGROUND
  • Yunas SU, Ozanyan KB. Gait Activity Classification Using Multi-Modality Sensor Fusion: A Deep Learning Approach. IEEE Sens J. 2021;21(15):16870-9.

    BACKGROUND
  • Manssor SAF, Sun S, Elhassan MAM. Real-Time Human Recognition at Night via Integrated Face and Gait Recognition Technologies. Sensors (Basel). 2021 Jun 24;21(13):4323. doi: 10.3390/s21134323.

    PMID: 34202659BACKGROUND

Results Point of Contact

Title
Asst. Prof. Gürkan ÖZDEN
Organization
Inonu University

Study Officials

  • Gürkan Özden, Assistant Professor

    Inonu University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ACeviz [Ahmet CEVİZ] Principal Investigator

Study Record Dates

First Submitted

May 13, 2025

First Posted

June 3, 2025

Study Start

June 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 24, 2025

Last Updated

December 2, 2025

Results First Posted

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the dataset contains sensitive health information, and there are no current plans or resources in place to support secure de-identification and controlled data access. Furthermore, the study protocol does not include provisions for data sharing.

Locations