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

Primary Purpose

Osteo Arthritis Knee, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Proprioception and Balance Program
Strengthening Program
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Rehabilitation, Pain, Functionality, Proprioception

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-Cerrahpasa, Faculty Of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Proprioception and Balance Training

Strengthening Training

Arm Description

Proprioception and Balance Program

Strengthening Program

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Universities Arthritis Index (WOMAC)
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.

Secondary Outcome Measures

Visual Analogue Scale (VAS)
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.
Pressure Algometer
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.
Hand-Held Dynamometer
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.
Isokinetic Dynamometer for measuring position sense
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.
Short Form-36
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.
Global Rating of Change Scale
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.
Aggregated Locomotor Function (ALF) Score
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.
Digital Goniometer
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.
Timed Up and Go (TUG) Test
Timed Up and Go (TUG) Test will be used clinical performance-based measure of lower extremity function, mobility and fall risk.
Tandem and Stand on One Leg
Tandem and Stand on One Leg will ve used to assesment of static balance of patients

Full Information

First Posted
March 7, 2019
Last Updated
August 11, 2020
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03893981
Brief Title
Strengthening Exercises Versus Proprioception and Balance Exercises in the Treatment of Knee Osteoarthritis
Official Title
Comparison of the Effect of Strengthening Exercises Versus Proprioception and Balance Exercises in the Treatment of Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
August 11, 2020 (Actual)
Study Completion Date
August 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Pain
Keywords
Rehabilitation, Pain, Functionality, Proprioception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proprioception and Balance Training
Arm Type
Experimental
Arm Description
Proprioception and Balance Program
Arm Title
Strengthening Training
Arm Type
Experimental
Arm Description
Strengthening Program
Intervention Type
Other
Intervention Name(s)
Proprioception and Balance Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Strengthening Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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.
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
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Title
Pressure Algometer
Description
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.
Time Frame
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Title
Hand-Held Dynamometer
Description
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.
Time Frame
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Title
Isokinetic Dynamometer for measuring position sense
Description
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.
Time Frame
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Title
Short Form-36
Description
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.
Time Frame
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Title
Global Rating of Change Scale
Description
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.
Time Frame
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Title
Aggregated Locomotor Function (ALF) Score
Description
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.
Time Frame
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Title
Digital Goniometer
Description
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.
Time Frame
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Title
Timed Up and Go (TUG) Test
Description
Timed Up and Go (TUG) Test will be used clinical performance-based measure of lower extremity function, mobility and fall risk.
Time Frame
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Title
Tandem and Stand on One Leg
Description
Tandem and Stand on One Leg will ve used to assesment of static balance of patients
Time Frame
Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze Kuş, MsC
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa, Faculty Of Health Sciences
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey

12. IPD Sharing Statement

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

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