Exercise Device in Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Investigation the Effectiveness of Exercise Device in the Rehabilitation of Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876431
• Other study ID #: 12/01/2018-17939
• Status: Completed
• Phase: N/A
• Start date: March 27, 2019
• Est. completion date: January 6, 2020

Study information

• Verified date: May 2024
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 6, 2020
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty
• Total Knee Replacement

Intervention

Device:
• Easy-Flex
The Easy-Flex device will be used to increase knee flexion and extension ROM.

Other:
• Exercise
After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.

Locations

Country	Name	City	State
Turkey	Istanbul Faculty Medicine	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	WOMAC	Measure of symptoms and physical disability	Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
Secondary	Satisfaction levels of the patients	Satisfaction levels of the patients with Global Rating of Change Score	At sixth week
Secondary	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.
Secondary	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.
Secondary	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.