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Total knee arthroplasty is performed in patients with advanced stages of osteoarthritis who can not respond to conservative treatment, in order to reduce pain, increase range of motion, and improve function and quality of life. Continuous passive motion device continues to be used in many clinics, although it has been shown that there is no effect in total knee arthroplasty rehabilitation. The aim of the study was to assess the clinical effects of the knee exercise device on pain, ROM and function and quality of life in total knee arthroplasty rehabilitation.
Volunteers with total knee arthroplasty according to the criteria of inclusion, who will be operated in Istanbul University Istanbul Medical Faculty Orthopedics and Traumatology Department will be included this study. Participants will be randomly allocated 2 groups: easy-flex group and traditional exercise group. Exercise group will be treated with the traditional exercise program and the Easy-Flex group will be treated with the Easy-Flex device in addition to the traditional exercise program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Exercise Group | Active Comparator | Only traditional exercises will be performed in the early post-op period. |
|
| Easy-Flex Group | Experimental | Easy-Flex group will be treated with the Easy-Flex device in addition to the traditional exercise program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Easy-Flex | Device | The Easy-Flex device will be used to increase knee flexion and extension ROM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change range of motion | Range of motion of knee flexion and extension | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. |
| Measure | Description | Time Frame |
|---|---|---|
| NPRS (Numerical Pain Rating Scale) | The levels of pain intensity measured using NPRS (Numerical Pain Rating Scale). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. |
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Inclusion Criteria:
Patients with TKA surgery due to the diagnosis of knee OA Between the ages of 45-80 years Patients with no difference over 5 cm in the extremity before and after surgery
Exclusion Criteria:
Revision TKA, Previous unicompartmental arthroplasty or tibial osteotomy, Hemophilia, Uncontrolled hypertension Rheumatic diseases, Lower extremity fractures and tumors, Neurological diseases leading to muscle weakness in the lower limbs, Patients with emotional and cognitive problems
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| Name | Affiliation | Role |
|---|---|---|
| Derya Çelik, Professor | Istanbul University Faculty of Health Sciences | Study Director |
| Zeynal Yasacı | Istanbul University Faculty of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Faculty Medicine | Istanbul | Fatih | 34147 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise | Other | After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied. |
|
| WOMAC | Measure of symptoms and physical disability | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. |
| Satisfaction levels of the patients | Satisfaction levels of the patients with Global Rating of Change Score | At sixth week |
| Short Form 12 (SF-12) | SF-12 is used to assess physical and mental health-related quality of life. The high scores are positively correlated with the high quality of life. | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. |
| 10 meter walking test | To test comfortable or maximal walking speed | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. |
| 5 sit to stand | To measure performance of lower extremity | Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program. |