Using Mobilization Exercises on Total Knee Arthroplasty Rehabilitation

July 16, 2018 updated by: Sezen Karabörklü Argut, Istanbul University

Effectiveness of Mobilization Exercises on Total Knee Arthroplasty Rehabilitation

There is no definite evidence about the most effective treatment approach in early-stage rehabilitation after total knee arthroplasty surgery. The purpose of this study is to investigate the effects of mobilization exercises applied with classical exercises on pain, joint range of motion, edema, function, quality of life and patient satisfaction in early stage rehabilitation after total knee arthroplasty surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is no definite evidence about the most effective treatment approach in early-stage rehabilitation after total knee arthroplasty surgery. The purpose of this study is to investigate the effects of mobilization exercises applied with classical exercises on pain, joint range of motion, edema, function, quality of life and patient satisfaction in early stage rehabilitation after total knee arthroplasty surgery. Patients with bicompartmental total knee arthroplasty operation due to knee osteoarthritis will randomly assign to 2 groups. Patients in group 1 will treat with mobilization exercises in addition to classical exercises performed in the early post-op period; patients in group 2 will treat only with classical exercises.

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
      • Istanbul, Turkey, 34740
        • Istanbul University

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

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with TKA surgery due to the diagnosis of knee OA
  • Between the ages of 50-75 years

Exclusion Criteria:

  • Revision TKA,
  • Previous unicompartmental arthroplasty or tibial osteotomy,
  • Hemophilia,
  • 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobilization Exercise Group
Mobilization exercises in addition to classical exercises performed in the early post-op period
Behavioral: Exercises
mobilization exercises (Patellofemoral joint, Tibiofemoral joint, Soft tissue) and classical exercises performed in the early post-op period
Active Comparator: Classical Exercise Group
only classical exercises performed in the early post-op period
Behavioral: Exercises
mobilization exercises (Patellofemoral joint, Tibiofemoral joint, Soft tissue) and classical exercises performed in the early post-op period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Range of Motion Degree at 2 weeks
Time Frame: Baseline, Post-op 2 weeks, and Post-op 2 months
Passive knee flexion range of motion
Baseline, Post-op 2 weeks, and Post-op 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Pain Degree at 2 weeks
Time Frame: Baseline, Post-op 2 weeks, and Post-op 2 months
Patient reported pain degree
Baseline, Post-op 2 weeks, and Post-op 2 months
Function
Time Frame: Baseline, Post-op 2 weeks, and Post-op 2 months
Functional Performance tests
Baseline, Post-op 2 weeks, and Post-op 2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction levels of the patients
Time Frame: At 2 months
Satisfaction levels of the patients with Global Rating of Change Score
At 2 months

Collaborators and Investigators

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

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 22, 2017

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

December 15, 2017

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 12, 2017

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22595

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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