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Clinical Trials/NCT06272825
NCT06272825CompletedNot Applicable

Effectiveness of Virtual Reality in Patients With Symptomatic Knee Osteoarthritis

Kirsehir Ahi Evran Universitesi1 site in 1 country60 target enrollmentStarted: May 28, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Visual Analog Scale

Study Overview

Brief Summary

One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation.

Detailed Description

Different VR systems have been shown to be effective in individuals with kinesiophobia as well as stroke patients. Virtual reality guided exercise is a proven method already used in stroke, Parkinson's, cerebral palsy rehabilitation, vestibular rehabilitation and orthopaedic rehabilitation. However, there is limited data on its effectiveness in patients with adhesive capsulitis. This randomized controlled study will contribute to the literature by investigating the effects of VR based exercises in individuals with AC

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

Investigator and Outcomes Assessor will be different persons.

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosis of chronic (>3 months) knee osteoarthritis between the ages of 40-85
  • •Kellgren and Lawrence Score ≥ 2 on knee radiograph
  • •Visual Analogue scale result VAS 4-8

Exclusion Criteria

  • •Orthopedic surgery performed on the lower extremity
  • •Cognitive dysfunction (Mini Mental Test Score <23)
  • •Having received any treatment for knee osteoarthritis in the last 6 months
  • •Following any ongoing exercise program (tai chi, pilates, yoga, fitness)
  • •History of ligament and ligament injury around the knee

Arms & Interventions

Experimental Group

Experimental

In addition to the conventional rehabilitation program at the hospital, virtual reality exercise will be applied in 15 sessions, 5 days a week.

Intervention: Virtual reality (Other)

Experimental Group

Experimental

In addition to the conventional rehabilitation program at the hospital, virtual reality exercise will be applied in 15 sessions, 5 days a week.

Intervention: conventional rehabilitation (Other)

Control group

Active Comparator

The conventional rehabilitation program at the hospital will be implemented in 15 sessions, 5 days a week.

Intervention: conventional rehabilitation (Other)

Outcomes

Primary Outcomes

Visual Analog Scale

Time Frame: Baseline

Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale. Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain. Increased scores indicate higher pain levels.

Visual Analog Scale

Time Frame: 3th week

Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale. Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain. Increased scores indicate higher pain levels.

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time Frame: Baseline

WOMAC was used to assess disability in patients with knee osteoarthritis. The WOMAC assesses pain, stiffness and physical function and consists of 24 items. Total score is between 24 and 120 points. A low score indicates mild illness, a high score indicates severe illness.

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time Frame: 3th week

WOMAC was used to assess disability in patients with knee osteoarthritis. The WOMAC assesses pain, stiffness and physical function and consists of 24 items. Total score is between 24 and 120 points. A low score indicates mild illness, a high score indicates severe illness.

Biodex Balance System

Time Frame: Baseline

The balance assessment of the participants will be made with the Biodex Balance Systems device. During the measurement, patients will try to stay balanced on the device whose platform stability is adjusted.

Biodex Balance System

Time Frame: 3th week

The balance assessment of the participants will be made with the Biodex Balance Systems device. During the measurement, patients will try to stay balanced on the device whose platform stability is adjusted.

Secondary Outcomes

  • Short Form 36 (SF36)(Baseline)
  • Short Form 36 (SF36)(3th week)

Investigators

Sponsor
Kirsehir Ahi Evran Universitesi
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Basak Cigdem Karacay

Principal Investigator

Kirsehir Ahi Evran Universitesi

Study Sites (1)

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