Strengthening Exercises Versus Proprioception and Balance Exercises in the Treatment of Knee Osteoarthritis

August 11, 2020 updated by: Gamze Kus, Istanbul University

Comparison of the Effect of Strengthening Exercises Versus Proprioception and Balance Exercises in the Treatment of Knee Osteoarthritis

The aim of the study is to investigate and compare the effect of balance and proprioception exercises with strengthening exercises on muscle strength, pain, proprioception, function and quality of life in knee osteoarthritis patients.

Study Overview

Detailed Description

Damage or loss of mechanoreceptors in osteoarthritis patients affects balance and proprioception. There are studies showing that proprioceptive deficit is associated with the onset and progression of knee osteoarthritis leading to pain and disability. Because the proprioception provides a sense of power generation and allows the power output to be better regulated. When the literature is examined, studies investigating the effects of proprioception and balance exercises on muscle strength, function and pain are limited.

In our study patients will be randomly divided into two groups: Group I (Proprioception and Balance) and Group II (muscle strengthening exercises). While Group I will be applied Proprioception and Balance training exercises, Group II will be applied closed and open kinetic strengthening exercises. Two group will perform exercise 3 times a week during 8 weeks.

Study Type

Interventional

Enrollment (Actual)

48

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

    • Bakirkoy
      • Istanbul, Bakirkoy, Turkey, 34147
        • Istanbul University-Cerrahpasa, Faculty of Health Sciences

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have a diagnosis of knee Osteoarthritis according to the American Society of Rheumatology (ACR) criteria,
  • Between 45 to 75 years of age
  • Can read and write in Turkish language

Exclusion Criteria:

  • Active synovitis
  • Taking any physical therapy section in the last 6 months
  • Have a neurological problems that affect walking
  • Have an arthritis problem in the ankle and hip joint
  • Have a history of lower extremity surgery
  • Intraarticular steroid injection in the last 6 months
  • Use psychoactive drug
  • Have a severe defect of vision and hearing, speech disorders
  • Vestibular dysfunction

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: Proprioception and Balance Training
Proprioception and Balance Program
Balance Trainer device and playing ball in tandem position for using to improve balance, vibration and reposition exercises for using to improve proprioception. Progressive of training will increase after each 2 weeks.Patients will be taken to the treatment program 3 days in a week for 8 weeks.
Experimental: Strengthening Training
Strengthening Program
Exercises which include open and closed kinetic chain exercise will be applied to strength knee and hip muscle. Progressive of training will increase after each 2 weeks. Patients will be taken to the treatment program 3 days in a week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: WOMAC will be filled first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program . After treatment "change" will be assessed

The WOMAC is widely used self-administered health status measure used in assessing pain, stiffness and function in patients with OA of the knee or hip. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).

The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

WOMAC will be filled first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program . After treatment "change" will be assessed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Pressure Algometer
Time Frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Pressure algometry is one of a number of outcome measures that manual therapy practitioners are able to use in both clinical and research settings. The pressure algometer is used to determine the pressure pain threshold of specific muscle and bone locations.
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Hand-Held Dynamometer
Time Frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Handheld dynamometers are one of the most objective and consistent tools to use when muscle testing. It is an ergonomic hand-held device for objectively quantifying muscle strength.
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Isokinetic Dynamometer for measuring position sense
Time Frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Isokinetic dynamometer is a well known device to measure active and passive JPS and also provides target angle result without any researcher bias/It has shown good reliability and validity for measuring position sense.
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Short Form-36
Time Frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of health related quality of life. The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health.
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Global Rating of Change Scale
Time Frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Global rating of change (GRC) scales are very commonly used in clinical research, particularly in the musculo-skeletal area These scales are designed to quantify a patient's improvement or deterioration over time, usually either to determine the effect of an intervention or to chart the clinical course of a condition. Global Rating of Change Scale will be used to evaluate patients' satisfaction from treatment.
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Aggregated Locomotor Function (ALF) Score
Time Frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
The aggregated locomotor function (ALF) score, a simple measure of observed locomotor function, using timed walking, stairs and transfers, was developed and evaluated for intra-tester reliability, criterion-related validity and responsiveness in a sample of patients with knee osteoarthritis.
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Digital Goniometer
Time Frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Digital Goniometer is a tool used most commonly for evaluating joint ROM in the clinical settings. Also it is a simple alternative for global use.
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Timed Up and Go (TUG) Test
Time Frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Timed Up and Go (TUG) Test will be used clinical performance-based measure of lower extremity function, mobility and fall risk.
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Tandem and Stand on One Leg
Time Frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Tandem and Stand on One Leg will ve used to assesment of static balance of patients
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Gamze Kuş, MsC, Istanbul University

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 16, 2019

Primary Completion (Actual)

August 11, 2020

Study Completion (Actual)

August 11, 2020

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

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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