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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893981
• Other study ID #: 99984023-302.99
• Status: Completed
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: August 11, 2020

Study information

• Verified date: August 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 11, 2020
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa, Faculty Of Health Sciences	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Secondary	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.	Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Secondary	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.	Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Secondary	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.	Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Secondary	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.	Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Secondary	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.	Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Secondary	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.	Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Secondary	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.	Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Secondary	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.	Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Secondary	Tandem and Stand on One Leg	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.