NCT03857698

Brief Summary

The aim of the study was to compare the efficacy of body stabilization exercises to be applied in addition to conservative physical therapy in patients undergoing total knee arthroplasty. Through this study, we aim to contribute to the literature and the clinic with objective, evidence-based results. Ostetoarthritis includes the entire joint in a disease process involving the loss of articular cartilage in focal and progressive hyaline, including the increase in osteophytes and the thickness of the subchondral bone. Clinical symptoms of osteoarthritis include joint stiffness, pain, and dysfunction. Knee osteoarthritis causes activity limitation especially in the elderly. American Society of Orthopedic Surgeons, nonsteroidal anti-inflammatory drugs or tramadol in the medical treatment of osteoarthritis; they recommend reinforcement in conservative treatment, low intensity aerobic exercises and neuromuscular training programs. Total knee arthroplasty is preferred for surgical treatment to reduce pain, improve deformity, and improve functional range and range of motion in patients with advanced stage osteoarthritis who do not respond to conservative treatment. Total knee arthroplasty is a surgical procedure in which an artificial joint replaces the damaged knee joint. After knee arthroplasty, there was a decrease in pain, increased range of motion and improved quality of life. Patients with osteoarthritis have a decrease in proprioceptive sensation due to inflammation in the knee joints and a decrease in knee mechanoreceptors. In addition to this proprioceptive disorder, muscle weakness caused by aging, decreased vision and losses in the central nervous system cause balance effects. This effect of equilibrium increases the fear of falling in individuals and therefore patients tend to move less. Therefore, the resulting inactivity causes a decrease in endurance with muscular force and causes the patients to become more immobile. This is particularly a risk factor for falls in patients with symptomatic lower extremity osteoarthritis and these causes mortality and morbidity. Lumbopelvic-hip complex or "core" in lumbar vertebrae, pelvis, hip joints and active and passive structures that produce or restrict the movement of these segments. Core stability is associated with lower extremity balance performance. Body stabilization exercises decrease the risk of falling patients and improve their balance. Although stabilization exercises are performed in patients with total prosthesis in the literature, there is no study evaluating the effectiveness of these exercises on balance, functional performance and lumbal lordosis angle.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

February 26, 2019

Last Update Submit

February 26, 2019

Conditions

Keywords

Total Knee ProsthesisStabilization ExerciseBalanceFunctional PerformanceLumbar Lordosis Angle

Outcome Measures

Primary Outcomes (1)

  • Evaluation of functional performance

    A timed up and go test is a test that assesses the mobility and lower extremity mobility.

    10 months

Study Arms (7)

Evaluation of pain

EXPERIMENTAL

The patient's pain will be evaluated by VAS (visual analog scale) at the end of the treatment, at the end of the treatment and at the end of the 3 months follow-up. For this, a 10 cm long line will be drawn. 0: painless and 10: the most severe pain is described and the patient will be asked to mark the value corresponding to the pain (rest, activity and night pain) on the scale.

Other: Conservative Physical TherapyOther: Body Stabilization Exercise

Evaluation of joint range of motion

EXPERIMENTAL

The flexion and extension range of motion of the knee joints of the patient will be measured in the prone position using a universal goniometer before and after the training.

Other: Conservative Physical TherapyOther: Body Stabilization Exercise

Assessment of balance

EXPERIMENTAL

Postural stability will be evaluated by a Prokin brand balance device (ProKin, Tecnobody, Bergamo, Italy), a force platform. After the tests are explained to the patients, the physical characteristics of the patients (age, height, body weight) will be recorded on the device and the device will be calibrated. The patients' feet will be placed naked on the platform with reference to the lines on the x and y axis. During the test, the arms will be in free position near the body. The tests will be performed on both feet with both eyes open and eyes closed. Each test will last 30 seconds. After each test has been completed, the device will be recalibrated. As a result of the tests, the ellipse area (mm2) and perimeter (mm) parameters will be recorded for statistical analysis. In addition, the patient's stability limits will be calculated as a percentage.

Other: Conservative Physical TherapyOther: Body Stabilization Exercise

Evaluation of functional performance

EXPERIMENTAL

A timed up and go test is a test that assesses the mobility and lower extremity mobility. For this test, the patient will be asked to lift from a chair with armrest (sitting height: 46 cm), walk 3 meters as fast as possible, turn around the colored band marked on the floor and sit in the same chair. The elapsed time for the motion will be recorded in seconds.

Other: Conservative Physical TherapyOther: Body Stabilization Exercise

Lumbar lordosis angle assessment

EXPERIMENTAL

During the test, patients will be asked to stand upright in a comfortable position. In the evaluation of the lumbar lordosis, the inclinometer will first be fixed to the T12-L1 backbone and then to the L5-Sl backbone and the angular values in both measurements will be collected and recorded as lordosis angle.

Other: Conservative Physical TherapyOther: Body Stabilization Exercise

Evaluation of knee functionality

EXPERIMENTAL

It will be measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). There are three subgroups, namely pain, stiffness and function. A total of 24 questions (pain 5 questions, 2 questions of malfunction and 17 questions of function) and the scale answered by patients are completed in approximately 5 minutes. The scale is a 5-point Likert-type scale (0 = none 1 = mild 2 = moderate 3 = severe 4 = very severe). The score range for the subgroup of pain is 0-20, for the subgroup group 0-8 and for the subgroup of function is 0 - 68. The total WOMAC score is obtained by the sum of these 3 points and the maximum total WOMAC score is 96. There is a linear ratio between the scores obtained from the WOMAC index and the presence of symptoms. The high scores were associated with severe symptoms, more disability and poor health status, whereas low scores indicated that symptoms, pain, and functionality were good.

Other: Conservative Physical TherapyOther: Body Stabilization Exercise

Assessment of lower extremity muscle endurance

EXPERIMENTAL

The patient will be asked to sit on the chair as fast as possible, so that the chair, which has a 46 cm height, will be crossed in the chest. The stopwatch is started with the command given to the patient and stopped in 30 seconds. The number of repetitions will be recorded.

Other: Conservative Physical TherapyOther: Body Stabilization Exercise

Interventions

Patients who were discharged from the hospital and received the sutures will be supervised 2 days a week for 8 weeks. Exercise programs will be promoted individually. * Ice application for pain, edema control * Patellar mobilization * Three-way straight leg lifting exercises * Isometric exercises around the hips and knees * Active assisted, active, resistant knee range of motion exercises * Heel shift exercises in supine and sitting * Hip abduction on the side lying * Stretching exercises for patients with gastrosoleus, hamstring, hip flexor muscles * Neuromuscular Electrical Stimulation (NMES) for quadriceps muscle of patients will be applied. The isometric quadriceps contraction observed during the procedure will be required to actively participate in the patients.

Assessment of balanceAssessment of lower extremity muscle enduranceEvaluation of functional performanceEvaluation of joint range of motionEvaluation of knee functionalityEvaluation of painLumbar lordosis angle assessment

In the first session, breathing control and alet abdominal hallawing of movement will be taught to the patients with the help of the pressure biofeedback device. The degree of difficulty of the exercises will be improved by using different positions, by adding rotations to the motion, making the pelvic control more difficult and increasing the number of repetitions. In case of exacerbation of symptoms, the level will not be advanced. Exercises will be advanced according to the patient's initial level and response to exercise. * Consecutive shoulder flexion and extension in supine * Building a bridge * Lower body and hip flip * Single leg extension with bilateral arm elevation * Resilient leg stretch with bilateral arm elevation * Hip external rotation in lateral hospitalization * Side-lying arm opening * Shoulder girdle retraction on ball, horizantal abduction and extension

Assessment of balanceAssessment of lower extremity muscle enduranceEvaluation of functional performanceEvaluation of joint range of motionEvaluation of knee functionalityEvaluation of painLumbar lordosis angle assessment

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Unilateral Total Knee Prosthesis Patients with full knee extension Patients with at least 80 degrees of knee flexion Mobilized (with ancillary equipment) Patients who can climb up and down stairs Patients who are not at risk for cardiac performance in terms of exercise and evaluation tests

You may not qualify if:

  • Another musculoskeletal problem that may affect lower limb performance A neurological or oncological disease that affects the balance Limb length difference of more than 5 cm before or after surgery Patients with any systemic problem Patients with infection in the knee after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, Esenboğa, 06970, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2019

First Posted

February 28, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations