Exercise Device in Total Knee Arthroplasty

May 9, 2024 updated by: Zeynal YASACI, Istanbul University

Investigation the Effectiveness of Exercise Device in the Rehabilitation of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34147
        • Istanbul Faculty Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional Exercise Group
Only traditional exercises will be performed in the early post-op period.
Other: Exercise
After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.
Experimental: Easy-Flex Group
Easy-Flex group will be treated with the Easy-Flex device in addition to the traditional exercise program.
Other: Exercise
After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.
Device: Easy-Flex
The Easy-Flex device will be used to increase knee flexion and extension ROM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC
Time Frame: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
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
Time Frame: At sixth week
Satisfaction levels of the patients with Global Rating of Change Score
At sixth week
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.
Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
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
Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
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
Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
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").
Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Director: Derya Çelik, Professor, Istanbul University Faculty of Health Sciences
  • Principal Investigator: Zeynal Yasacı, Istanbul University Faculty of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2019

Primary Completion (Actual)

August 20, 2019

Study Completion (Actual)

January 6, 2020

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12/01/2018-17939

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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