NCT06977529

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

March 24, 2025

Last Update Submit

May 13, 2025

Conditions

Keywords

ALGORİTHMFALLPATİENT SAFETYTOTAL KNEE ARTHROPLASTY

Outcome Measures

Primary Outcomes (1)

  • FALL

    Patients' fall status will be recorded by asking questions in the "Patient Questionnaire Form".

    Perioperative period , Within 30 days after surgery.

Study Arms (2)

EXPERİMENTAL

EXPERIMENTAL

The "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients.

Behavioral: Algorithm; Algorithm-based maintenance created by researchers:such as falls training, early mobilization

control

NO INTERVENTION

No intervention was made by the researcher.

Interventions

The "Fall Prevention Algorithm" prepared by the researchers was applied to the experimental group patients.

EXPERİMENTAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who will undergo emergency surgery,
  • Have hearing and speech problems,
  • Have visual impairment,
  • Have conditions that may affect cognitive functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Universty

Gaziantep, ŞAHİNBEY, 27900, Turkey (Türkiye)

Location

MeSH Terms

Interventions

AlgorithmsEarly Ambulation

Intervention Hierarchy (Ancestors)

Mathematical ConceptsRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 24, 2025

First Posted

May 18, 2025

Study Start

January 20, 2024

Primary Completion

June 4, 2024

Study Completion

June 20, 2024

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations