- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06977529
- Original Trial
Fall Prevention in Total Knee Replacement Patients
May 13, 2025 updated by: Sibel ARSLAN, University of Gaziantep
The Effect Of Algorithm-Guided Care Provided To Total Knee Prosthesis Patients On Fall And Recovery: Randomized Controlled Trial
Falls, one of the patient safety goals, lead to injury and death if not prevented.
This study was conducted to determine the effect of algorithm-guided care on falling, fear of movement, fear of falling and postoperative recovery index for patients with total knee replacement surgery at high risk of falling.
The research was conducted as a randomized, controlled and experimental study in the orthopedic clinics of a city hospital and a state hospital between 20.01.2024 and 04.06.2024.
The sample of the study consisted of 56 patients who would undergo total knee replacement surgery with a high risk of falling.
The patients were divided into two groups: experimental (n=28) and control (n=28) groups.
"Patient Questionnaire", "Postoperative Recovery Index (ASII)", "Tampa Kinesiophobia Scale (TKÖ)", "International Fall Effectiveness Scale (UDES)" were applied to all patients participating in the study.
The "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Şahi̇nbey
-
Gazi̇antep, Şahi̇nbey, Turkey, 27900
- Gaziantep Universty
-
-
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
Description
Inclusion Criteria:
- Having a unilateral total knee replacement surgery for the first time,
- Not having a psychiatric illness diagnosis,
- Being able to speak and understand Turkish,
- Being willing to participate in the research.
Exclusion Criteria:
- Patients who will undergo emergency surgery,
- Have hearing and speech problems,
- Have visual impairment,
- Have conditions that may affect cognitive functions
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EXPERİMENTAL
The "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients.
|
The "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients.
|
|
No Intervention: control
No intervention was made by the researcher.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FALL
Time Frame: Perioperative period , Within 30 days after surgery.
|
Patients' fall status will be recorded by asking questions in the "Patient Questionnaire Form".
|
Perioperative period , Within 30 days after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 20, 2024
Primary Completion (Actual)
June 4, 2024
Study Completion (Actual)
June 20, 2024
Study Registration Dates
First Submitted
March 24, 2025
First Submitted That Met QC Criteria
May 13, 2025
First Posted (Actual)
May 18, 2025
Study Record Updates
Last Update Posted (Actual)
May 18, 2025
Last Update Submitted That Met QC Criteria
May 13, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Gaziantep Unıv.
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
product manufactured in and exported from the U.S.
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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