- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07650175
Balance, Fall Risk, and Gait in Women With Total Knee Arthroplasty
Investigation of Balance, Fall Risk, Gait Performance, and Quality of Life in Postmenopausal Women Undergoing Total Knee Arthroplasty
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Total knee arthroplasty (TKA) is one of the most frequently performed surgeries aimed at reducing pain, restoring limb function and alignment, enabling normal joint movement, and increasing the level of independence in daily living activities. TKA is frequently performed in women aged 65-84 years.
In recent years, advancements in surgical techniques and prosthetic technology, along with increased surgeon experience, have broadened the range of indications for this surgery. Following TKA, balance, fall risk, and walking performance in patients can negatively impact their daily living activities and quality of life, preventing the achievement of expected rehabilitation results. While reports indicate a reduction in complaints and an increase in functional level and quality of life after TKA surgery, clear conclusions regarding patients' balance, fall risk, and walking performance have not been reached. This study differs from other studies in the literature by comprehensively evaluating the effects of TKA on critical functional parameters such as balance, fall risk, walking performance, and quality of life in postmenopausal women. While most research focuses on the effect of TDA on only one or two parameters, this study will examine four key components together, providing a more holistic assessment. Evaluating these parameters, which significantly affect the success of TDA surgery, will determine the rehabilitation process and program. Furthermore, the fact that participants scored 24 points or higher on the Mini-Mental Test will increase the reliability of the results by providing a sample capable of cognitive assessment. The aim of this study is to compare the effects of TDA surgery on balance skills, gait performance, fall risk, and quality of life in postmenopausal women who have and have not undergone the procedure.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Nurcan Contarli, Doctor
- Numero di telefono: +90 370 418 9171
- Email: nurcancontarli@karabuk.edu.tr
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
control group
not having undergone TKA
|
having undergone TKA
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Single Leg Standing Test
Lasso di tempo: 1 day
|
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
Lasso di tempo: 1 day
|
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
Lasso di tempo: 1 day
|
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
Lasso di tempo: 1 day
|
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
Lasso di tempo: 1 day
|
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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- KBU-FTR-NC-11
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Protesi totale di ginocchio
-
University of GroningenCompletato
-
The First Affiliated Hospital with Nanjing Medical...ReclutamentoSpondiloartrite (SpA) | Risonanza magnetica total body (WBMRI)Cina
Prove cliniche su TKA group
-
Maisonneuve-Rosemont HospitalAttivo, non reclutanteSoddisfazione personale | Genu VarumCanada
-
The University of Tennessee, KnoxvilleSmith & Nephew, Inc.CompletatoArtrosi al ginocchio | Protesi totale di ginocchio | GinocchioStati Uniti
-
Ewha Womans UniversityCompletatoArtrite | Artropatia del ginocchio | Robotica
-
Chinese University of Hong KongNon ancora reclutamentoArtrosi al ginocchio | Protesi totale di ginocchioHong Kong
-
Orthopaedic Department of General University Hospital...MicroPort Orthopedics Inc.ReclutamentoComplicazioni dell'artroplastica | Artropatia del ginocchio | Artroplastica robotica assistita | Risultati di TKAGrecia
-
Mahidol UniversityCompletatoArtropatia del ginocchioTailandia
-
Aesculap AGTerminatoOsteoartrite | Artrite reumatoide | Artrite post-traumaticaGermania
-
Medisch Centrum LatemMicroPort Orthopedics Inc.ReclutamentoArtrosi al ginocchio | Intervento chirurgico di sostituzione totale del ginocchio | Artroplastica totale del ginocchio \ (tka \)Belgio
-
Peking University Third HospitalCompletatoChirurgia robotica | Antroplastica totale del ginocchioCina
-
Orthosensor, Inc.Terminato