Arthroplasty, Replacement, KneeNCT03857698
The Effect of Body Stabilization Exercises on Balance, Functional Performance and Lumbar Lordosis Angle in Patients With Total Knee Prosthesis
A study testing Conservative Physical Therapy and Body Stabilization Exercise in people with Arthroplasty, Replacement, Knee, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Conservative Physical Therapy and Body Stabilization Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara, Esenboğa, 06970
Emre Uysal, Bachelor, 0 505 864 04 74, emreuysal-95@hotmail.com
About this study
Official title: The Effect of Body Stabilization Exercises on Balance, Functional Performance and Lumbar Lordosis Angle in Patients With Total Knee Prosthesis: Randomized Controlled Double Blind Study
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.
Read more
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.
Read the detailed description
A prospective, randomized controlled, double-blind clinical study was performed in unilateral total knee arthroplasty (TDP) surgery with a cross-linking, fixed insert, cemented total knee prosthesis and the same type of surgical technique. Ankara Yenimahalle Training and Research Hospital Patients admitted to the Rehabilitation Policlinic will be included in the study. Pre-study volunteers will be randomly assigned into two groups by giving information about the purpose and content of the study. The participants will be evaluated by a blind researcher before, after and 3 months after the treatment and the data obtained from the evaluation results will be analyzed by appropriate statistical methods.
Patients who have at least 80 degrees of knee flexion and full knee extension, who can be mobilized (with ancillary equipment), who can go up and down the stairs, without any infections, will be included in the study after their sutures have been taken. Patients will be randomly divided into two groups as education group and control group. The patients in the control group will undergo a conservative physical therapy program under the supervision of the physiotherapist. The patients in the training group will be given conservative treatment and body stabilization exercise program under the supervision of physiotherapist. The assessments before and after the treatment and after 3 months will be performed by another physiotherapist who does not know what treatment the patients are receiving. Pre-treatment, post-treatment and 3-month post-treatment pain with visual analog scale, joint motion range with goniometer, functional performance with time up and go test, balance with Prokin balance device (ProKin, Tecnobody, Bergamo, Italy), lumbal lordosis angle with Baseline Bubble Inclinometer®, knee functions with Western Ontario and McMaster Universities Osteoarthritis Index, the lower extremity muscle endurance with 30 second chair stand test will be evaluated. Patients in both groups will be treated for a total of 8 weeks 2 days a week.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Conservative Physical Therapy, Body Stabilization Exercise
- Keywords
- Total Knee Prosthesis, Stabilization Exercise, Balance, Functional Performance, Lumbar Lordosis Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative Physical TherapyOther
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.
Body Stabilization ExerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Conservative Physical Therapy; Other: 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. Receives: Other: Conservative Physical Therapy; Other: 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. Receives: Other: Conservative Physical Therapy; Other: 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. Receives: Other: Conservative Physical Therapy; Other: 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. Receives: Other: Conservative Physical Therapy; Other: 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. Receives: Other: Conservative Physical Therapy; Other: 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. Receives: Other: Conservative Physical Therapy; Other: Body Stabilization Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of functional performance
A timed up and go test is a test that assesses the mobility and lower extremity mobility.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857698
- Sponsor's protocol ID
- 20190105
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2019
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Stabilization Exercises on Balance, Functional Performance and Lumbar Lordosis Angle in Patients With Total Knee Prosthesis: Randomized Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT03857698
- Acronym / sponsor ID
- 20190105
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Total Knee Prosthesis, Stabilization Exercise, Balance, Functional Performance, Lumbar Lordosis Angle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective, randomized controlled, double-blind clinical study was performed in unilateral total knee arthroplasty (TDP) surgery with a cross-linking, fixed insert, cemented total knee prosthesis and the same type of surgical technique. Ankara Yenimahalle Training and Research Hospital Patients admitted to the Rehabilitation Policlinic will be included in the study. Pre-study volunteers will be randomly assigned into two groups by giving information about the purpose and content of the study. The participants will be evaluated by a blind researcher before, after and 3 months after the treatment and the data obtained from the evaluation results will be analyzed by appropriate statistical methods.
Patients who have at least 80 degrees of knee flexion and full knee extension, who can be mobilized (with ancillary equipment), who can go up and down the stairs, without any infections, will be included in the study after their sutures have been taken. Patients will be randomly divided into two groups as education group and control group. The patients in the control group will undergo a conservative physical therapy program under the supervision of the physiotherapist. The patients in the training group will be given conservative treatment and body stabilization exercise program under the supervision of physiotherapist. The assessments before and after the treatment and after 3 months will be performed by another physiotherapist who does not know what treatment the patients are receiving. Pre-treatment, post-treatment and 3-month post-treatment pain with visual analog scale, joint motion range with goniometer, functional performance with time up and go test, balance with Prokin balance device (ProKin, Tecnobody, Bergamo, Italy), lumbal lordosis angle with Baseline Bubble Inclinometer®, knee functions with Western Ontario and McMaster Universities Osteoarthritis Index, the lower extremity muscle endurance with 30 second chair stand test will be evaluated. Patients in both groups will be treated for a total of 8 weeks 2 days a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Evaluation of pain | Experimental | Other: Conservative Physical Therapy, Other: Body Stabilization ExerciseThe 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. |
| Evaluation of joint range of motion | Experimental | Other: Conservative Physical Therapy, Other: Body Stabilization ExerciseThe 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. |
| Assessment of balance | Experimental | Other: Conservative Physical Therapy, Other: Body Stabilization ExercisePostural 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. |
| Evaluation of functional performance | Experimental | Other: Conservative Physical Therapy, Other: Body Stabilization ExerciseA 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. |
| Lumbar lordosis angle assessment | Experimental | Other: Conservative Physical Therapy, Other: Body Stabilization ExerciseDuring 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. |
| Evaluation of knee functionality | Experimental | Other: Conservative Physical Therapy, Other: Body Stabilization ExerciseIt 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. |
| Assessment of lower extremity muscle endurance | Experimental | Other: Conservative Physical Therapy, Other: Body Stabilization ExerciseThe 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative Physical TherapyPatients 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. | Other | Assessment of balance, Assessment of lower extremity muscle endurance, Evaluation of functional performance, Evaluation of joint range of motion, Evaluation of knee functionality, Evaluation of pain, Lumbar lordosis angle assessment |
| Body Stabilization ExerciseIn 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 | Other | Assessment of balance, Assessment of lower extremity muscle endurance, Evaluation of functional performance, Evaluation of joint range of motion, Evaluation of knee functionality, Evaluation of pain, Lumbar lordosis angle assessment |
Primary outcome
Evaluation of functional performance
Time frame: 10 months
A timed up and go test is a test that assesses the mobility and lower extremity mobility.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative Physical Therapy and Body Stabilization Exercise in people with Arthroplasty, Replacement, Knee, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of functional performance (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.