Balance, Fall Risk, and Gait in Women With Total Knee Arthroplasty

NCT07650175 | Not Yet Recruiting

• 1 other identifier: KBU-FTR-NC-11
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Total knee arthroplasty (TKA) is a commonly performed surgical procedure aimed at reducing pain, restoring joint function, and improving quality of life, particularly among older women. Despite improvements in pain and functional outcomes following TKA, findings regarding balance, fall risk, and gait performance remain inconsistent. Impairments in these parameters may adversely affect daily activities, independence, and overall quality of life. Unlike previous studies that have primarily focused on one or two outcomes, this study will comprehensively evaluate balance, fall risk, gait performance, and quality of life in postmenopausal women who have undergone TKA. The findings are expected to provide a more holistic understanding of long-term functional outcomes following TKA and contribute to the planning of rehabilitation programs. Therefore, the aim of this study is to compare balance, fall risk, gait performance, and quality of life between postmenopausal women who have undergone TKA and healthy postmenopausal women.

Conditions

Total Knee Arthroplasty; Postmenopausal Women; Quality of Life (QOL); Balance; Risk of Falling; Walking

Outcome Measures

Primary Outcomes (5)

• Single Leg Standing Test

  Single Leg Standing (SLJ) Test: Balance assessment will be performed using the single leg standing (SLJ) test. In the SLJ test, participants will be asked to stand with their extremities on the side that has not undergone surgery raised. The duration of the test in this position will be recorded. If the participant completes this position for 30 seconds, the test will be recorded as successful. Sarac et al. determined the validity and reliability of the SLJ test in TDA patients as an intraclass correlation coefficient \[ICC\]=0.74 (0.48-0.87).

  1 day

• 30-Second Sit-to-Stand Test

  For the test, the individual sits in the middle of a chair without armrests, with a seat height of 43.18 cm, with their back straight, arms crossed over their chest, and feet flat on the floor. Upon the "Start" command, they rise from the chair without pushing off with their arms, stand upright, and then sit down again. Prior to the evaluation, the individual is assessed for two sit-to-stand repetitions to ensure they have learned the procedure. The number of correct standing repetitions within 30 seconds is recorded as the test value.

  1 day

• Timed Up and Walk Test

  The individual is asked to stand up from a chair, walk 3 meters at a safe and normal pace, turn around, walk back, and sit back down in the chair. The time is recorded in seconds. The test will be initiated with the patient's feet flat on the floor and their arms resting on the armrests of the chair. Three repetitions will be performed, and the best result will be recorded.

  1 day

• 10-Meter Walking Test

  The 10-meter walking test will be used to assess walking ability. In this test, the individual will be asked to walk at their normal pace in a pre-measured 10-meter area (with or without walking aids). The timer will start when the individual's foot is on the starting line and end when they cross the finish line. Two measurements will be taken, and the best value will be recorded in meters per second (m/s).

  1 day

• Oxford Knee Score

  It is a scale developed in 1998 to investigate pain and functional status in individuals with knee replacement, and its validity and reliability have been proven (47). The validity and reliability of the score in Turkish was proven by the research conducted by Tugay et al. in 2016 (48). The Oxford knee score is a score consisting of 12 questions that include the problems the individual has experienced in their knee in the last 4 weeks. The questions will be answered by individuals choosing the most appropriate situation for themselves from 5 answers related to each question. The answers given will be scored from 0-4 and the results will be totaled. The raw score is a value between 0-48.

  1 day

Study Arms (1)

control group

not having undergone TKA

Other: TKA group

Interventions

TKA group OTHER

having undergone TKA

control group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Gender Eligibility Details: being a postmenopausal woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women who have and have not undergone total knee arthroplasty.

You may qualify if:

• Volunteering to participate in the study.
• Being 60 years of age or older.
• Having a Mini Mental Test score of 24 or higher.
• Not having undergone previous arthroplasty surgery on the knee where surgery is planned.
• Having experienced unilateral TDA.
• Being a postmenopausal woman

You may not qualify if:

• Individuals whose vital signs are unstable after surgery, or who develop any major complications such as deep vein thrombosis, pulmonary embolism, wound infection, or prolonged anesthesia side effects.
• Presence of any neurological, vestibular, visual, cardiopulmonary, auditory, or cognitive deficits that may affect measurements.
• Individuals diagnosed with diabetes.

Sponsors & Collaborators

• Karabuk University: lead

Central Study Contacts

Nurcan Contarli, Doctor

CONTACT

+90 370 418 9171; nurcancontarli@karabuk.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: June 20, 2026
• Primary Completion: July 20, 2026
• Study Completion: July 22, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share