Comparison of the Effects of Different Treatment Modalities in Individuals with Knee Osteoarthritis

NCT05893017 | Completed DMC

• 1 other identifier: E-68869993-511.06-765176
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis (gonarthrosis) is one of the most common types of osteoarthritis. It is a degenerative joint disorder characterized by pain, muscle weakness, and functional loss. There have been no studies comparing the effects of conservative treatment approaches such as virtual reality exercises, orthoses, and kinesio taping. Therefore, the aim of this current study is to compare the effectiveness of virtual reality exercises alone and in combination with orthotic approach and kinesio taping in individuals with knee osteoarthritis. The participants included in the study will be randomly divided into three groups. The first group will receive virtual reality exercises, the second group will receive virtual reality exercises along with valgus orthosis, and the third group will receive virtual reality exercises combined with kinesio taping treatment. The interventions will be applied three times a week for eight weeks. Evaluations will be repeated before and after the exercise therapy. The evaluations will include pain assessment using the Visual Analog Scale (VAS), muscle strength measured by hand dynamometer, balance assessed by the Berg Balance Scale, proprioception measured by stabilizer and inclinometer, joint range of motion measured by goniometer, functional status evaluated by the WOMAC scale, lower extremity length measured by tape measure, walking speed assessed by the 10-Meter Walk Test (10 MWT), quality of life measured by the SF-36 questionnaire, kinesiophobia evaluated by the Tampa Scale for Kinesiophobia, architectural features of the quadriceps femoris muscle assessed by ultrasound imaging, knee OA score measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS), and medial compartment distance of the knee calculated and recorded using computer-aided analysis on anteroposterior radiographs.

Conditions

Gonarthrosis; Primary

Keywords

Gonarthrosis; Virtual Reality Exercises; Valgus Orthosis; Kinesiotaping

Outcome Measures

Primary Outcomes (3)

• Muscle Architectural Evaluation with USG

  Before and after the treatment, pennation angle calculation and muscle thickness measurement will be made at the 4 heads of the Quadriceps Femoris muscle (vastus medialis, lateralis, intermedius and rectus femoris). These measurements will be evaluated from the middle of the thigh (between the trochanter major of the femur and the midpoint of the lateral condyle of the femur) while the patient is lying in the supine position. Muscle thickness will be measured as the distance between the superficial and deep aponeuroses by applying the vertical and maximum pressure of the USG probe. Pennation angle measurement will be determined by placing the USG probe longitudinally from the middle of the thigh and measuring the angles where the muscle fascicles attach to the deep aponeurosis.

  2 months

• Knee medial compartment distance

  The minimum width remaining medially between the tibia and the femur will be recorded in millimeters. The minimum joint space width will be measured as the distance between the bones in the medial tibiofemoral region. The minimum distance is between the distal femur and the proximal tibia. The point where the convex line of the medial condyle of the femur is lowest is marked. From this point, the place where the perpendicular drawn on the ground intersects with the tibial plateau is marked. The medial compartment distance of the knee is calculated by recording the distance in millimeters between these two marked points. The decrease in the distance can be interpreted as an increase in the varus deformity of the knee.

  2 months

• Tibiofemoral angle measurement

  It is calculated by AP X-ray taken while the patient is in the standing position. It is found by the angle between the anatomical axis of the femur and the anatomical axis of the tibia. Its normal value is between 2.2 and 7.4. This angle is affected by all angle-related values of the lower extremity. Therefore, it is highly correlated with functional capacity. An angle above the normal value indicates valgus, and a decrease below the normal value indicates varus deformity in the lower extremity.

  2 months

Study Arms (3)

Virtual Reality Exercises

EXPERIMENTAL

Virtual Reality Exercises will be applied

Other: Virtual Reality Exercises

Virtual Reality Exercises and Kinesiotaping

EXPERIMENTAL

Virtual Reality Exercises and Kinesio taping for quadriceps and hamstring muscles will be applied

Other: Virtual Reality Exercises and Kinesiotaping

Virtual Reality Exercises and Valgus Orthoses

EXPERIMENTAL

Virtual Reality Exercises and Valgus Orthoses will be applied.

Other: Virtual Reality Exercises and Valgus Orthoses

Interventions

Virtual Reality Exercises OTHER

Virtual Reality Exercises will be apply for muscle strengthening

Virtual Reality Exercises

Virtual Reality Exercises and Kinesiotaping OTHER

Virtual Reality Exercises will be apply for muscle strengthening, Kinesiotaping will be applied at Quadriceps muscle and Hamstring muscle

Virtual Reality Exercises and Kinesiotaping

Virtual Reality Exercises and Valgus Orthoses OTHER

Virtual Reality Exercises will be apply for muscle strengthening, Orthoses is for correction at knee alignment

Virtual Reality Exercises and Valgus Orthoses

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals between the ages of 40-65,
• Those diagnosed with medial compartment knee OA, grade 2-3 according to the Kellgren-Lawrence classification,
• Patients who can stand on one leg for at least 30 seconds

You may not qualify if:

• Presence of neurological problems,
• Operation in the lower extremities or spinal column,
• Severe vision, speech, hearing problems,
• Inability to walk independently,
• Having a BMI of more than 35,
• Receiving physical therapy and rehabilitation due to gonarthrosis in the last year.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Amasya Healthy Life Center

Amasya, Turkey (Türkiye)

Location

Related Publications (5)

• Barrios JA, Higginson JS, Royer TD, Davis IS. Static and dynamic correlates of the knee adduction moment in healthy knees ranging from normal to varus-aligned. Clin Biomech (Bristol). 2009 Dec;24(10):850-4. doi: 10.1016/j.clinbiomech.2009.07.016. Epub 2009 Aug 22.

  PMID: 19703728 BACKGROUND

• Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, Heyse SP, Hirsch R, Hochberg MC, Hunder GG, Liang MH, Pillemer SR, Steen VD, Wolfe F. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998 May;41(5):778-99. doi: 10.1002/1529-0131(199805)41:53.0.CO;2-V.

  PMID: 9588729 BACKGROUND

• Hunt MA, Birmingham TB, Bryant D, Jones I, Giffin JR, Jenkyn TR, Vandervoort AA. Lateral trunk lean explains variation in dynamic knee joint load in patients with medial compartment knee osteoarthritis. Osteoarthritis Cartilage. 2008 May;16(5):591-9. doi: 10.1016/j.joca.2007.10.017. Epub 2008 Feb 21.

  PMID: 18206395 BACKGROUND

• Lephart SM, Pincivero DM, Rozzi SL. Proprioception of the ankle and knee. Sports Med. 1998 Mar;25(3):149-55. doi: 10.2165/00007256-199825030-00002.

  PMID: 9554026 BACKGROUND

• Gellhorn AC, Stumph JM, Zikry HE, Creelman CA, Welbel R. Ultrasound measures of muscle thickness may be superior to strength testing in adults with knee osteoarthritis: a cross-sectional study. BMC Musculoskelet Disord. 2018 Sep 27;19(1):350. doi: 10.1186/s12891-018-2267-4.

  PMID: 30261863 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fatih ERBAHÇECİ

  Hacettepe University

  STUDY DIRECTOR

• Eren ARABACI

  Amasya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. / Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 7, 2023
• Study Start: February 27, 2024
• Primary Completion: October 6, 2024
• Study Completion: October 7, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 01.06.2023-01.16.2024
• Access Criteria: Must be one of the researchers of this study

Locations

TU (1)