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Clinical Trials/NCT04011553
NCT04011553
Completed
N/A

The Effectiveness of Virtual Reality Based Rehabilitation in Patients With Knee Osteoarthritis

Istanbul Medeniyet University1 site in 1 country60 target enrollmentApril 21, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Istanbul Medeniyet University
Enrollment
60
Locations
1
Primary Endpoint
Kinesiophobia
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

We aimed to investigate the effects of virtual reality based rehabilitation program on patients with knee osteoarthritis.

Detailed Description

Sixty volunteer participants with knee osteoarthritis aged 40 to 65 years who were at stage of 2-3 according to the Kellgren Lawrence radiological evaluation were included in the study. Participants were randomly divided into two groups as virtual and control group. While a conventional physiotherapy program consisting of electrotherapy and exercise program was applied to both groups 5 days a week for 6 weeks, a virtual reality program was added to the virtual group for 6 weeks, 5 days a week. At the beginning of the treatment and at the end of the sixth week, ROM, pain, kinesiophobia, proprioception, balance, muscle strength and functional status were evaluated between groups.

Registry
clinicaltrials.gov
Start Date
April 21, 2018
End Date
May 29, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Medeniyet University
Responsible Party
Principal Investigator
Principal Investigator

EMEL METE

RESEARCH ASSISTANT

Istanbul Medeniyet University

Eligibility Criteria

Inclusion Criteria

  • knee osteoarhritis aged 40 to 75 years who were at stage of 2-3 according to the Kellegren Lawrence radiological evaluation were included in the study.

Exclusion Criteria

  • Those who have received physical therapy in the last 6 months
  • Having serious systemic and cardiovascular diseases that may prevent exercise
  • Neurological and orthopedic problems affecting gait
  • Those with sensory defects
  • Malignancy diagnosed
  • Those who have received PRP (Platelet-Rich Plasma) treatment or intra-articular steroid injection treatment in the last 6 months
  • With metal implants
  • Serious hearing loss or visual impairment
  • Communication problems

Outcomes

Primary Outcomes

Kinesiophobia

Time Frame: Change from baseline kinesiophobia at week 6.

Kinesiophobia was assessed with TAMPA Scale for Kinesiophobia (TSK). TSK is a 17-item measure that assesses kinesiophobia (fear of movement). Each item is evaluated on a 4-point Likert scale with scoring alternatives ranging from 'strongly disagree' to 'strongly agree. Total scores range from 17 to 68, with higher scores reflecting greater kinesiophobia.

Knee Pain

Time Frame: Change from baseline knee pain at week 6.

Pain was evaulated with VAS (Visual Analog Scale). The VAS consists of a 10 cm straight line which presents a continuum of intensity and has verbal anchors at opposite ends representing 'no pain' at the bottom and 'pain as bad as it can be' at the top. The participants were asked to mark the representing point of their pain levels. The values were recorded in cm .

Severity of the knee Osteoarthritis

Time Frame: Change from baseline severity of knee osteoarthritis at week 6.

Severity of the knee Osteoarthritis of participants was evaulated with "Western Ontario and McMaster Universities Arthritis" (WOMAC LK 3.1). The WOMAC LK has 24 questions in three subscales (pain , stiffness, physical functions) and a total of 24 questions. Each item is scored 0 to 4. Maxiumum score is 96. the higher the scores indicate that the severity of the disease is worse.

Muscle Strength of Knee extensor and flexor Muscles

Time Frame: Change from baseline muscle strength at week 6.

Muscle Strength was evaulated with Biodex System Pro 4 Isokinetic Dynamometer (Biodex Medical Systems, Inc, Shirley, NY. USA). The subjects were seated in such a position that knee and hip were at 900 flexion, and shoulders, ankle and pelvis were fixed to the machine. The centre of the knee joint was aligned with the centre of the dynamometer by using a laser-pointing device. Before testing, 5-min warming programme was performed by using treadmill. Isokinetic test was performed with 5 repetitions at 1200/s and 2400/s angular velocities. Tests were performed in a standardized order and all subjects have received identical instructions and encouragements.

Knee Proprioception

Time Frame: Change from baseline knee proprioception at week 6.

Knee proprioception was evaulated with MarVAJED system (Marmara Visual Auditory Joint Education Device). MarVAJED® is used in virtual rehabilitation and also has test software which can evaluate knee proprioception. The sensors of the system were placed on the upper and lower parts of the knee joint. The subjects were asked to lie down in prone position. The system was calibrated and then the knee joint was passively flexed at 30 degree. Participants were allowed to wait for ten minutes in this position to perceive the degree of knee flexion. Then the knee joint was passively brought back to the initial position and the patients were asked to actively flex their knee at 300 with their eyes closed. The same protocol was performed in 60 degree. . The difference between the reference degree and the degree that the subject performed during the test was automatically calculated by the MarVAJED system.

Functionality

Time Frame: Change baseline from functionality at week 6.

Functionality of participants was evaulated with Aggregated Locomotor Function (ALF) test. Aggregated Locomotor Function (ALF) test consists of three parts: stair climbing, walk and transfer tests. The time was recorded for each of the tests. longer periods mean that functionality is worse.

Postural Balance

Time Frame: Change from baseline postural balance at week 6.

PEDALO® Sensamove Balance System was used to evaluate postural balance of subjects.It has a balance board in which consists of sensors to record and process data about balance performance to a computer.

Range of Motion (ROM)

Time Frame: Change from baseline Range of Motion (ROM) at week 6.

The active range of motion of knee (flexion, extension) was assessed by using a universal goniometer. Kendall-McCreary criteria was considered in the assessments. Measurements were repeated three times and the average value was used in the statistical analysis.

Study Sites (1)

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