Skip to main content
OpenTrials
Completed

NCT Number: NCT03876431

Exercise Device in Total Knee Arthroplasty

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Total Knee Arthroplasty Total Knee Replacement

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Faculty Medicine

Istanbul, Fatih, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Easy-Flex

Device

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

Exercise

Other

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

Primary outcomes

  1. Change range of motion

    Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

    Range of motion of knee flexion and extension

Secondary outcomes

  1. NPRS (Numerical Pain Rating Scale)

    Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

    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").

  2. WOMAC

    Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

    Measure of symptoms and physical disability

  3. Satisfaction levels of the patients

    Time frame: At sixth week

    Satisfaction levels of the patients with Global Rating of Change Score

  4. Short Form 12 (SF-12)

    Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

    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.

  5. 10 meter walking test

    Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

    To test comfortable or maximal walking speed

  6. 5 sit to stand

    Time frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

    To measure performance of lower extremity

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 15, 2019
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.