Clinical trial NCT03876431: Exercise Device in Total Knee Arthroplasty
Official title: Investigation the Effectiveness of Exercise Device in the Rehabilitation of Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Total Knee Replacement
Keywords: Knee prosthesis
Physiotherapy
Range of motion
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 42
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change range of motion
timeFrame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
Secondary outcomes:
measure: NPRS (Numerical Pain Rating Scale)
timeFrame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
measure: WOMAC
timeFrame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
measure: Satisfaction levels of the patients
timeFrame: At sixth week
measure: Short Form 12 (SF-12)
timeFrame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
measure: 10 meter walking test
timeFrame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
measure: 5 sit to stand
timeFrame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Faculty Medicine
state: Fatih
Study officials:
affiliation: Istanbul University Faculty of Health Sciences
name: Derya Çelik, Professor
role: STUDY_DIRECTOR
affiliation: Istanbul University Faculty of Health Sciences
name: Zeynal Yasacı
role: PRINCIPAL_INVESTIGATOR
References: